Transitional provisions for certain medical devices and in vitro diagnostic medical devices

The transition period extension is excellent; however, it fell short of addressing another very concerning problem for the EU and its citizens. Access to innovation seems to move further and further from Europe.

EuromContact agrees with the initial postulate of the proposal : many devices which may be placed on the market in accordance with the initial MDR transitional provisions are not going to be certified in accordance with that Regulation before the end of the transition period, which leads to a major risk of shortages of medical devices in the EU.

At the EPSCO Health Council on December 9, 2022, the Commission had announced to put forward a TARGETED LEGISLATIVE PROPOSAL at the beginning of January 2023 TO ADDRESS the IMMINENT RISK OF SHORTAGES of MEDICAL DEVICES in Europe and the associated risk of a public health crisis, stemming from the Medical Device Regulation (MDR) implementation challenges.

Thank you to the Commission for this pragmatic proposal finally. Requirements, classification rules and deadlines to comply with MDR are disproportionate to the risks (i.e: class I to class IIa). It also induces a lot of exorbitant costs for the MD manufacturers and an incredible bottleneck for all the stakeholders. So, we are in favor to extend the transition period since it looks mandatory.

As a Medical device manufacturer, we support the proposal for an MDR amendment to mitigate the risks of shortages of medical devices in the EU Market. However, the following are still unclear: 1) The proposal states that the extension is directly applicable so that notified bodies are not required to change the date on the individual certificates.

Although extension may seem beneficial for timely certification and recertification of devices, more important is to precisely understand the root cause of the current situation. What failed to happen in 7 years after signing the law in May 2016, will most probably fail again when the new deadlines in this proposal approach. I would like to mention two serious concerns here.

Thank you for the proposal and the explanatory memorandum. I would just like to provide feedback on points that remain unclear. 'Appropriate surveillance' in the context of 120 (3d) (c) which states that if the device presents an unacceptable risk to health and safety, the extended transition period would cease for that device, should be clarified.

We understand the reasons listed for the extension amongst others due to the insufficient number of notified bodies, but the legislation must divide "medical devices" from the "medical device software", which must maintain the same deadlines. We are talking about perhaps hundreds of software MDR's versus hundred times as many "simple" devices.

The Advanced Medical Technology Association (AdvaMed) would like to highlight the utmost importance of ensuring the continuity of patient care in Europe and underscores the comments submitted by MedTech Europe, which highlight the importance for adoption of this legislative proposal as swiftly as possible, as follows -- MedTech Europe takes note of the European Commission's proposal to amend the transitional…

The current proposed extension of the transition period for medical devices can alleviate some of the concerns on certifying existing medical devices and avoid shortage of medical devices. It remains to be seen if the additional time and notified bodies will be sufficient to address pending research and clinical investigations which require also to be addressed by the notified bodies.

In May 2017, the MDR entered into force with the goal to increase the safety of medical devices, raise the requirements for the clinical evaluation of high-risk devices, harmonise assessment by Notified Bodies throughout Europe and increase transparency via a central database on medical devices available on the EU market (EUDAMED).

We are both in line with the new regulatory requirements that make it possible to advance the safety and performance of MDs and also fully in line with this proposed amendment, which could allow companies and notified bodies (scarce and expensive resources) to certify products in accordance with Regulation (EU) 2017/745 without the consequences of supply disruption for the health system.

Filed in French · English published by the European Commission

The opportunity raised by the European Commission for a possible extension of the term of expired and winning certificates favors manufacturers and the European Community. For the European Community, a possible shortage caused by the delay and complexity of obtaining an CE certificate through MDR would be avoided, consequently there would be an increase in the prices of medical devices, which would result in…

AFIDEO represents European manufacturers, importers and distributors of orthopedic and trauma implants. AFIDEO welcomes the principle and text of the European Commission's amendment to MDR 2017/745. The extension of the certificates until the end of 2027/2028 eliminates the risk of a massive shortage of medical devices in May 2024.

Amgen appreciates the opportunity to provide our comments on the Proposal for an Extension of the Transitional Provisions for Certain Medical Devices and In Vitro Diagnostic Medical Devices (IVDs). Amgen commends the European Commission for its proposal to protect access to on-market devices and IVDs and strongly supports efforts to extend the transition period for these products.

The European Federation of Pharmaceutical Industries and Associations (EFPIA) represents the biopharmaceutical industry operating in Europe. EFPIA appreciates the opportunity to provide comments on the Proposal for an Extension of the Transitional Provisions for Certain Medical Devices and In Vitro Diagnostic Medical Devices (IVDs), issued on 6 January 2023.

In view of the risk of shortages in the supply chains of medical devices currently in use, we understand the extension of the proposed transition period. A functioning certification system (sufficient number of NBs, with sufficient experts) is a prerequisite for the implementation of the regulatory change.

— Among the conditions for the extension of the MDD certificates, we would like to have the following clarifications: o Aview a QMS compliant with MDR: in what form will this condition be verified? Intervention by the ON? Manufacturer’s declaration of conformity?

Filed in French · English published by the European Commission

Forge agrees with the proposed delay in the transition to the MDR and the abolition of the sell-off deadline in the MDR and IVDR. Further, Forge would like to see additional measures taken to extend IVDR implementation delays or exemptions to companion diagnostics associated with orphan drugs or drugs targeting severe diseases with unmet medical needs (e.g., 'PRIME products).

We strongly support this legislative proposal to amend the MDR and the IVDR. However, we would like to provide several comments. MDR art 120.3 d e) It is foreseeable that the number of certification applications that the NBs will receive until May 26, 2024 (that is to say in 15 months from now) will be extremely large.

Thank you for the opportunity to give feedback on the "Medical devices transition period extension" initiative. My feedback is as follows: ad §1. overall capacity of conformity assessment (notified) bodies remains insufficient to carry out the tasks required: Why is the focus here on capacity but not the task as such?

The extension of the validity of the MDD certificates under the MDR is, in our opinion, essential to ensure adequate availability of medical devices on the market. However, we do think that only extending the validity of the certificates without taking any further actions will lead to the same problems as we face today when the new deadlines approach.

The MDR extension until 2027-2028 is an excellent news. It will give necessary time to the manufactures as well to the NB to be prepared for MDR. However, the expired certificates could create big problems for tenders and for export activities.

ADIFA as a national association full-member of GIRP - European Healthcare Distribution Association, strongly encourages the European Commissions proposal for a Regulation on the transitional provisions for certain medical devices and in vitro diagnostic medical devices and the extension of the time to certify the medical devices according to their risk class and that will remove the sell-off date, by allowing…

The Medtech & Pharma Platform Association (MPP) is writing to you to share its views on the European Commissions proposal regarding the transition periods of the Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR). Overall, the MPP supports and welcomes the proposal, which is crucial to ensure the continued supply of products to patients.

The Blood Transfusion Association (BTA) welcomes the Commissions recognition of the urgent risks of medical device shortages in Europe stemming from the challenges posed by the transitional provisions in the Medical Devices Regulation.

Great proposal. Thing are going in the right direction. One question though: Are the exceptions mentioned in Article 1 of the proposal (sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors) related to class IIb implantable devices only or to both class IIb implantable devices AND class III devices?

MDR and IVDR implementation proposal 2023/0005 (COD) leaves us desperate. Everything proposed does not address the structural problem this legislation has created. For sorting the structural problem out and saving the regulations from a fully confirmed fail in the end, leaving EU medtech on the ruines of what once was the world leader in innovation and exposing patients to shortages is the following: - Conformity…

As evaluators of innovation in health and in particular of medical devices, the draft amendment to the regulations is consistent with the vision and feedbacks that we daily have, from our industrial contacts, researchers, doctors and patients.

ICON welcomes the proposal as a way to avoid severe consequences arising from the predicted shortage of medical devices due to expiration of CE certificates. However, lengthening the transition period may have unintended consequence of delaying the introduction of beneficial modifications to the design or intended use of legacy devices.

The European Association of Authorized Representative (EAAR) welcomes the extension for the MDR compliance of legacy products and fully supports a fast implementation. It will allow for a smoother transition in particular for small and medium size manufacturers.

The Snitem (National Medical Technology Industry Union) takes note of the European Commission’s proposal to adapt the transitional measures of Regulation (EU) 2017/745 on medical devices and welcomes its recognition of the urgent and persistent risks of shortages of medical devices in Europe resulting from the implementation challenges of the Regulation.

Filed in French · English published by the European Commission

Notified Bodies are currently lacking sufficient capacity to certify not only existing devices which are transitioning to the MDR (in accordance with the transitional provisions) but also new devices requiring certification for the first time. Consequently, and as highlighted in the preamble to the proposal, this is threatening the availability of medical devices on the EU market.

The paragraphs of the amendment described below would require clarification in order to facilitate their application: — Paragraph: 1.1.b page 8: what does the latest mean in the paragraph below? Can a Notified Body take responsibility for monitoring before a written agreement is signed?

Filed in French · English published by the European Commission

This modification is urgently required and now becomes reality much faster than we had expected! This modification makes the transfer doable but still means that all partners need to stay focused on the running projects - especially the notified bodies need to continue all activities like additional people, etc.

We welcome this proposal to amend the end of the MDR transitional period. However, some questions remain unanswered. 49 were expected for MDR, with only 36 at present. What is the deadline for notification of NAOs? This amendment, although proposed, will not change much if there is not enough body to deal with the certification files.

Filed in French · English published by the European Commission

The proposal to extend the transition period is most welcome. With regards to the proposed amendment on MDR 2017/745, article 120, paragraph 3, it would be great to consider allowing changes to design that do not negatively affect the benefit risk profile of the product or can (even) improve the product and ultimately benefit the patient for low risk devices.

This is a satisfactory proposal for the manufacturers. However, the fact that NBs are not obliged to renew the certificates, or at least to draft an amendment, confirming the extension of the validity date will pose a problem for distributors who will not be able to check that the CE certificate is in force, as well as for National Authorities outside Europe that recognize the CE marking.

Thank you to the Commision for the extended tranistion period proposal. The extended transition time were very much needed and welcomed. However, the wordings in original english proposal texts needs clarity especially considering the fact that its translated into numerous other languages.

We support the MD transition period extension. Nevertheless, we still see the following ambiguities or amendment requirements here: -Regarding Article 1 of the amendment in paragraph 2, the creation period of certificates May 25, 2017 should be deleted and May 26, 2021 should be considered sufficient -The certificates are renewed without updating.

Concerning the transition period extension, we request to clarify the application linked with the validity lead time specified with notified bodies. In order to remain simple and efficient, it appears that the solution to update CE certificate with extension of validity period has to be written. As international company, CE certificate is used as reference for a lot of countries registration.

We would like to thank the Commission for the proposal for the extension and for the opportunity to comment this proposal. There is a proposal for the extension of the transition period for class IIa, IIb and III medical devices as well as for class Im, Is, Ir. There are no remarks concerning medical devices, that are class I products MDD.

Extended transition period is mandatory to avoid medical device ecosystem collapse and patient care deterioration. However, extending transition time alone doesn't solve the numerous issues still present with the MDR: 1/ EUDAMED being still incomplete, 2/ the delay in publishing the harmonized standards, 3/ the over cautious classification of devices, notably for software as per rule 11 (while more pragmatic…

MedTech Europe takes note of the European Commissions proposal to amend the transitional measures in the Medical Devices Regulation (EU) 2017/745 and welcomes its recognition of the ongoing urgent risks of medical device shortages in Europe stemming from the Regulation implementation challenges.

The German Chamber of Commerce and Industry (DIHK) supports the planned extension of the deadline for existing products. This will give all actors more time to overcome the existing bottlenecks. The abolition of the sales period is also important in order to avoid unnecessary destruction of already produced safe medical devices.

Filed in German · English published by the European Commission

Citing the Russian aggression in Ukraine and the Covid Pandemic as justification for the extension seems disingenuous when the root-cause has been the failure to institute a system to designate an adequate cadre of Notified Bodies in a timely manner.

Due to the pandemic and the postponement of the issuance of MDD certificates, we have lost money and time, which cannot be compensated retrospectively. Normally, CE certificates are valid for five years. The MDR deadline has been postponed to May 2021, which gives us a period of three years of certificate validity till May 2024.

Dear Sirs, This amendment is welcome. As manager of a company operating in this sector, I want to IMMEDIATELY SUGGEST evaluating the following points to be applied in the transitional period: 1) it is necessary to go back to the previous certification rules to allow companies and notified bodies to carry out their work; 2) significant modifications to products must be allowed for multiple reasons (lack of materials…

We agree with the extension of the transitional period and the removal of the sell-off deadline, but this may be useless if additional measures are not taken by the Commission, MDCG, Competent Authorities, and Notified Bodies. It is not a bottleneck, it is a blocked pipe and we will face the same situation in 2027.

The extension is necessary given the current situation to guarantee the safety of European patients. The backlog of notified bodies and certification/audits significantly delays access to the EU market and therefore increases manufacturer expenses and costs. Getting regulatory approval is a very important milestone for the success of small companies and start-ups.

We act for a number of manufacturers of Annex XVI products. They welcome the proposed amending text for MDR Article 120, contained in the Proposal. This clarifies that Certificates issued [] as from 25 May 2017 that were valid on 26 May 2021 and that have not been withdrawn afterwards *shall remain valid* after the end of the period indicated on the certificate until [either 31 December 2027 or 31 December 2028] if…

From our viewpoint as clinical trial center of an academic hospital, our concerns regarding the extension proposal reflect mainly the clinical investigations. In the past year we have set up a Medical Device Framework Board, as proposed by the MDCG, to document the assessments and choices of regulatory pathways of clinical investigations planned to take place at our institution.

We are in favor and welcome the extension of the transition period for the MDR implementation in order to maintain uninterrupted supply to European markets. We want to highlight two aspects 1. A design freeze (see article 1b of the proposal extension of the transition period, second bulletin point) during the transitional period till 2027 respective 2028 remains a challenge based on the fact that ECHA continues to…

Dear Sir, Further to my initial comments under comment reference F3375233, I read with considerable interest comments by others. Particular insight from many commenters indicates the Commission, in not consulting stakeholders properly, embarking on intervention only at such a late point and not tackling fundamental problem- which is how conformity is assessed by ill-conceived or unformulated measures- can simply be…

We are in favor to the extension of the transition period for medical devices. Our Notified Body has only recently (December 2022) acquired the authorization to notify according to the Regulation (EU) 2017/745 on medical devices. The time frame for the NB to recertify the devices it's not enough, considering that the certification procedure duration is long: (it takes three months for each familys devices.

With the proposal for a Regulation (2023/0005) submitted on January 6, 2023 extending the transition period of the EU regulations on medical devices, the European Commission is working to ensure smooth implementation of its regulatory framework for medical devices, ensuring their availability, safety and effectiveness.

Thank you for this amendment, which should allow companies and NAs to carry out more ‘tightly’ the implementation of Regulation (EU) 2017/745. However, we have concerns about the arrangements for extending EC certificates under the relevant Directives (93/42/EC...), which is therefore not required in the proposed text, I quote: “The extension is directly applicable, so that notified bodies are not required to change…

Filed in French · English published by the European Commission

As academic hospital and research institution, we face more issues than just expired certificates. This proposal does not resolve these issues, in fact, it only makes it more complicated since we need to be sure that the medical devices we purchase/use are compliant to legislations and are effective and safe to use in our patients.

This is Gökhan Yalçın from Turkey. We are Medical Device CE Certification Consultancy Company. Notified Bodies are requesting Technical documentation in 3 months to review when you sign an agreement with them. If the notified body doesn't get them on time, they may omit your application and agreement.

Regarding the proposal of revision of Article 120(3), the condition (e) no later than 26 May 2024, the manufacturer, or an authorized representative, has lodged a formal application in accordance with Section 4.3, first subparagraph, of Annex VII for conformity assessment in respect of a device referred to in paragraphs 3b and 3c of this Article or "in respect of a device intended to substitute that device", and no…

Firstly, thank you for listening to industry & accepting to consider extending transition times; without wanting to push further the debate, nor react to certain comments used to justify the difficulties above all I really hope now that Europe will learn from this stupendously horrendous experience and its never ever repeated.

Dear, The transition to PSD has been deliberately postponed by many (large) companies in order to force postponement. As a result, the notified bodies are now becoming too short of the capacity to meet the high demand. If the transition to the PSD had started earlier, this problem had not arisen. As a result, the peak load would now have been much lower. It would not be necessary to postpone it.

Filed in Dutch · English published by the European Commission

The medical device regulation was intended to improve the safety and quality of medical devices and to bring a harmonized regulatory framework for medical devices across the EU. However, the implementation of the MDR has caused disruptions in the medical device industry, with some manufacturers raising prices or discontinuing certain devices due to the added costs and regulatory burdens.

It is a great news for the manufacturer; we have one comment: The expired date on the CE certificates won't change, that may cause confusion to customs, to foreign governments, to clients; is it possible to find a way to avoid the confusion? e.g. NB issue a formal letter.

Distributor of medical devices. Everyone is aware that we are heading for a DM shortage disaster if we keep going this way, or even see the disappearance of small and medium-sized companies. We have qualified Witnessed the disappearance of certain niche DMS for overly expensive upgrading in accordance with the requirements of the MDR.

Filed in French · English published by the European Commission

Being a company already MDR certified, this proposal is adding major additional activities by notified bodies. Notified Bodies will become more than before the unique bottleneck of all MDR compliance activities.

This proposal to extend the transitional period is crucial in several respects: * allow a quality assessment of the dossiers submitted in accordance with MDR * to spread out the need for resources for these evaluations for NAOs * to avoid abandonment of certain MDs, which are very used for care or for the quality of life of patients * avoid the loss of competitiveness of the European medical device industries, which…

Filed in French · English published by the European Commission

Dear all, As MDR Project Manager within the company Aptissen SA based in Switzerland we are nowadays impacted by the transition to the MDR 2017/745. We're facing big delays in order to have the review of our Technical Files to obtain the certification under MDR.

Hello This report is absolutely essential and should not be called into question. I am Médecin hospitalo-Universities, Fondateur d unE startup developing a highly innovative medical device (labeled deeptech by bpi) to.Poitiers (SomnoEngineering.SAS) L congestion of the notified bodies is a major argument for investment funds and bissness angels not to finance seed startups...

Filed in French · English published by the European Commission

Symatese really appreciates the efforts from EU commission with the support of competent authorities to find solutions for patients, physicians, distributors and legal manufacturers. The transition period extension is one good approach at short term, even if we have to set up solutions and new processes in order not to simply postpone the issues.

Thank you for the proposal for the extension. Kindly request text of proposal be shortened and simplified in an easily readable fashion and straight forward manner. Here are some recommendations. In the attachment is the reasoning. Time extension for all medical devices regardless of risk classification, including custom-made devices, should be the same year: either 2027 or 2028.

There is an oversight within the proposal for transitional arrangements in respect of Annex XVI products that have now been brought within scope of the Medical Regulation. Whilst new Common Specifications have recently been established for such products, they do not benefit from existing conformity certificates under the former Medical Devices Directive.

With regard to Article 1(1), point (a), of the proposal - extension of the validity of certificates. We propose a change to the following requirement be considered: As regards certificates that have already expired when the proposed amendment comes into force, the extension would be subject to the condition that, at the moment *of the expiry*, the manufacturer has signed a contract with a notified body for the…

The main issue with this proposal is that it does not fix the root cause of the problem. With the current rate of 1000 certificates issued per year, it will take till 2041 to renew all MDD certificates. MDCG 2022-14 nicely addresses root causes, but their advises could at best give a slight push in the right direction. There are no guarantees that the certification rate will increase in the coming years.

January 17, 2023 RE: MDMA Comments regarding amending regulations EU 2017/745 and EU 2017/746 Dear EU Commission representatives: We appreciate the EU Commission proposal to amend EU 2017/745 and EU 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices.

As a small manufacturer we support the commissions efforts to alleviate the backlog of certifications to the MDR with the proposed legislation. However, we ask that the Commission consider making certain provisions effective from the time that the legislation is passed, or some date after, rather than on conditions that could have taken place in the past, but which manufacturers and other participants can no longer…

Euro-Pharmat welcomes the consideration of the situation that suggested major risks in terms of MD availability and, as a result, a serious failure in patient care. Already, today, on a daily basis, healthcare professionals encounter a number of supply tensions, or even disruptions due to the impossibility for manufacturers to renew in due time the CE marking of MD previously certified according to the MD…

Ladies and Gentlemen, our company sells IVD products and is therefore exclusively concerned by the proposed amendment to the IVDR. The planned extension of the sales period has only a slight positive impact on our product portfolio, as the reagents we sell are stable for a maximum of 1.5 years and thus only result in an extension of the sale option of a maximum of 6 months.

Filed in German · English published by the European Commission

Overall, the proposal and the extension of the deadline are very good. With the extension of the transitional period, the next health crisis will be averted for the first time. Proven and safe medical devices, essential for sometimes vital treatments, remain available. However, the extension of the deadline merely shifts the problems to the future.

Filed in German · English published by the European Commission

Good day. Whitney Medical Solutions is a (very) small U.S. manufacturer of simple sterile medical devices (Class Is), registered under the FDA for many years. We applied for and received our first (and only) CE Mark under MDD one of our products shortly before the deadline for MDD expiration in 2021.

We support the solution of extending the transition periods to prevent disruption of medical devices provision in European Union. But other solutions may be proposed. A lot of requirements are excessive with regards to the risk class of the medical devices (for instance : software and its classification rule #11).

This proposal is needed and is a good news,but 2 aspects need to be reviewed : Article 1(1), point (a), of the proposal extension of the validity of certificates : In some third parties' countries it is required to have certificates with valid dates it is critical for the business to have NB re-editing the Certificates with the extended dates Article 1(1), point (b), of the proposal extension of the transition…

The extension period will be beneficial for both industries and Notify Bodies. What is the meaning of: 'the devices do not present an unacceptable risk to the health or safety of patients, users or other persons, or to other aspects of the protection of public health'? The removal of the legal time restriction (27 May 2025) is a real great sensible decision.

Dear Sir, Thank you for the opportunity to comment on COM(2023) 10 final 2023/0005 (COD) proposing extension to period of transition to Regulations (EU) 2017/745 and (EU) 2017/746, respectively. Accordingly, please would you find attached comments and observations. Yours faithfully [name removed] International OU

On 6 January, the European Commission presented a proposal to amend the Medical Devices Regulation (MDR). The proposal extends the transitional period for adaptation to the new certification rules under the MDR. In doing so, the European Commission responds to the ongoing debate on the threat of shortages of urgently needed medical devices.

Filed in German · English published by the European Commission

Hello, I agree to extend the transition period to avoid the shortage of DM and periods of supply disruption, especially for patients. For companies, the difficulties currently encountered in re-certification of medical devices (reduction in the number of NAOs and increase in the time taken to audit files according to MDR) will not ensure the certification of medical devices before 05/2024.

Filed in French · English published by the European Commission

From our perspective the intended changes to the MDR brings new risks to the respective industries as well to the patients, thus jeopardizing one of the original intentions of the MDR legislation. Although supply chain related concerns might be prudent, the solution must not deteriorate the quality of the health system, as the current draft creates new systematic risks for patient safety.

Dear Sir/Madam, We, as Dogpa Medical Device Company, believe there is a gap for sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors devices with the proposed amendment. For these devices including sutures, there is no extension proposed.

Dear Sir/Madam, We, as Dogsan Surgical sutures, believe there is a gap for sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors devices with the proposed amendment. For these devices including sutures, there is no extension proposed.

Thank you for giving us the opportunity of commenting on the proposal. We believe there is a gap for sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors devices with the proposed amendment. For these devices including sutures, there is no extension proposed.

Thank you for giving us the opportunity of commenting on the proposal. We believe there is a gap for sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors devices with the proposed amendment. For these devices including sutures, there is no extension proposed.

I believe that their is a huge risk to patient safety if products are not available between their CE certificate expiring and new MDR certificate being issued. Products are having to be temporarily withdrawn from the market as notifiable bodies are not able to keep up with the demands of assessing products through the more stringent MDR process with technical files to review etc and are significantly behind…

In the view of an Austrian software manufacturer (SHL Solutions for Healthcare and Life-Sciences GmbH), an extension of the transitional period is absolutely necessary, as the shortage of notified bodies and the length of the procedure make it impossible to place products on the market in due time.

Filed in German · English published by the European Commission

Manufacturer and distributor of medical devices, we are in favour of extending the transitional period of Regulation 2017/745. The difficulties currently encountered in re-certification of medical devices (reduction in the number of NAOs and increase in the time taken to audit files according to MDR) will not ensure the certification of medical devices before 05/2024.

Filed in French · English published by the European Commission

As a distributor with a very wide range of medical devices, technical products, mainly single-use devices, I very much need an extension of the deadlines. The tight supply situation would be significantly aggravated by the current deadlines. The current proposal would significantly reduce the capacity shortage situation of certification bodies and thus significantly increase security of supply.

Filed in German · English published by the European Commission

The extension of transition period is necessary because certification process takes a long time. Knowing that MDR certification deadline would be 2027 from the beginning would have allowed manufacturers to certify their products in 2 phases (first to better understand the global process, and second to adapt to all technical files).

It is satisfactory that the European Commission is finally examining the possibility of relaxing the transition period to new certification, but this postponement will not interrupt the decisions already taken in our company. EC (under the Directive) certification of our medical devices manufactured in France expired in August 2022. We have tried to postpone this deadline to the health authorities without success.

Filed in French · English published by the European Commission

The proposal has the following weaknesses: 1. It creates an uneven playing field. MDCG 2022-18 exempts legacy devices, or economic operators involved in legacy devices, from certain requirements (e.g. PRRC, SSCP, UDI, etc.). Worse, manufacturers of MDR-certified devices cannot show there is a benefit in being early, while companies at the lower end of the compliance scale can hide for much longer.

Hello, this extension was very much expected. Thank you for taking into account the demands and very great concerns of the industrial and economic world. We remain very concerned about the long-term effects of this new regulation in terms of competitiveness and innovation capacity for European businesses. We are a startup of Class 2A medical devices (surgical instrumentation).

Filed in French · English published by the European Commission

Moin from Lübeck! I have the following questions: What happens to the allowances still in force – which expire in May 2024? Are these automatically extended to the relevant cut-off date? What is planned for the Notified Body Capacity? Is there a simplification in the takeover of MDD to MDR by the Notified Bodies of the main files already examined – as there is a shortage of time?

Filed in German · English published by the European Commission

The proposed amendment for MDD certified legacy devices with documented history of safe use is long overdue given the limited number of qualified notified bodies, their resource limitations, and general inability to conduct the conformity assessment process with consistency and alignment to an agreed upon contract date.

Would it be possible for the amendment to the MDR and IVDR to be made more clear with respect to how it will impact on new medical devices and / or existing medical devices which are subject to significant change in design or intended purpose?

The extension of transition period is a good thing because certification process takes a long time and it is not possible to certify all products at the same time. Knowing that MDR certification deadline would be 2027 from the beginning would have allowed manufacturers to certify their products in 2 phases (first to better understand the global process, and second to adapt to all technical files).

We strongly support the extension of the MRS transitional period, which is vital for DM manufacturers and especially for notifying bodies which are under pressure and are unable to absorb all pending requests. In France with a single notifying body, it is very difficult to plan an assessment before 2024. Furthermore, there is a great risk of shortages and stopping the marketing of MDs essential for patients’ health.

Filed in French · English published by the European Commission

It is important that medical devices that have existed for many years and do not show a negative trend from a safety and performance point of view can be audited more quickly with a lighter process (e.g. review of new data only). It is essential that documentary audits of devices be prioritised according to the date of their submission.

Filed in French · English published by the European Commission

1. Will EC certificates be extended after 2024? If not, which valid document can we provide for export records? 2. In Article 1 (3) (c), there is a condition to continue placing the DM on the market after 2024: “the devices do not present an unacceptable risk to the health or safety of grandants, users or other persons, or to other aspects of the protection of the public health – > who will assess this aspect? 3.

Filed in French · English published by the European Commission

Mr PREVOR supported the proposed extension of the transitional period of Regulation 2017/745. However, in paragraph 5 of the explanatory document of 6/01/2023, it is stated for Article 1 (1) (a) that the voltage would be directly applicable so that the NAs would not have to change the dates on the EC certificates.

Filed in French · English published by the European Commission

Hello, we are a start-up developing a software medical device that was previously self-certified under the old Directive 93/42/EEC. Although we have started our transition upstream, we are facing significant challenges in implementing Regulation (EU) 2017/745. Firstly, as a small company with an innovative product, it is difficult to find a notified body; obtaining feedback from a Notified Body alone is complicated.

Filed in French · English published by the European Commission

We completely support and approve of this proposal to extend the transition period for medical devices, especially the spirit of the initiative detailed in the explanatory memorandum section. Its a true testament to a pragmatic reaction to the current state of the medical device industry, all stakeholders considered.

The proposed change to implementation timetable is a welcome relief. It will enable manufacturers to continue to supply, clinicians to prescribe and patients to have access to the necessary range of medical devices without harmful interruption. We are able to comment authoritatively on this as leading advisors on medtech policy across the EU. www.whitehousecomms.com

En tant que Société de Consulting pour entreprises Françaises, fabricants de dispositif médicaux, nous sommes entièrement favorables pour cette proposition damendement au règlement(UE) 2017/745 pour lextension de la période de transition.

A suggestion is to give companies with already approved MDR-products latest May 25th 2024 two years, from last certificate, until next notify body audit date. We are against the postponement of the dates to accommodate for the laggards, and slow moving Notified Bodies. Everyone have had a chance to be diligent and on time.

Hello, we agree on the draft new timetable for compliance with Regulation 2017-745.This extension will allow time to comply while maintaining product safety and performance. Best regards,

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This measure seems essential to enable manufacturers to contract with a notified body, especially for those who did not need a NAO under the MDD. However, this measure will not be sufficient if the number of NAOs and their availability do not increase.

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It is the opinion of MOSS, on the basis of the experience gained in the course of the MDR transition of its certificates, that the proposed amendment shows the following criticalities: Uneven competition between Manufacturers: Legacy Devices will not be required to have in place many relevant requirements such as e.g. SSCP, PRRC, liability. MDR devices must instead have all of these requirements in place.

Hello Ladies, Gentlemen, I am in favour of extending the transitional period for the full application of RDM 2017/745. This period seems to me to be even too short when one takes into account the difficulties on the ground, both on the side of the Notified Bodies (NAO) and the Manufacturers: they are enormous and serious: To recruit resources (human resources and skills), with rapid capacity to re-evaluate the…

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As manufacturers of IIb active medical devices, we do support the proposal for amending Regulation (EU) 2017/745. At present, our Notified Body cannot even schedule assessment audits for our existing MDD technical files to transit to MDR as they have limited resources. Under MDR, they should have experts for each MDA code which is currently not the case.

Devant l'impossibilité des organismes notifiés d'étudier les dossiers sous Règlement (UE) 2017/745 dans un délai relativement court (moyenne d'étude de 2 ans), il devient nécessaire et vital pour l'industrie du biomédical Européen de prolonger les certificats CE sous Directive de plusieurs années.

Hello, an additional transitional period for legacy devices seems essential since the bodies were notified very late and the processing times for cases are relatively long, with numerous exchanges between the manufacturer and the NAO. On the other hand, some devices require skills that not all notified bodies have or have very limited resources.

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The removal of the “close-out” period beyond which devices placed on the market before or during transition periods and which are still in the supply chain should be withdrawn is absolutely necessary. Maintaining that deadline would have disastrous consequences for the sector of renting of medical equipment. If DM stocks on sale are easy to sell, a DM Multi-User may have a lifetime of more than 15 years.

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The Commission's proposal is ridiculous to say least. The extension of transitional period based on Article 120 will cause huge chaos in already existing, quite complicated regulatory environment for medical devices. What will the Commission do then with local legislation issued under MDR - will withdraw it?

It is a very good initiative to postpone deadlines until May 2024. Unfortunately, this does not solve all the problems: the disappearance of many MSW manufactured in Europe. MDR2017/745 would have exempted devices on the market for many years, which have proved their worth – for which manufacturers no longer want to invest significant amounts such as MDR certification.

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As a distributor, the transition is difficult to manage because some suppliers see their MDD certification expire without having MDR certification. the Medical device is then no longer available on the market and finding alternatives may be difficult. This can lead to stock-outs

The extension of the transition period for medical devices would be an excellent news for the sector. As things stand, if nothing is done, notified bodies will not have the capacity to manage all the files that are and must be submitted by manufacturers, which will inevitably lead to disruptions in the supply of medical devices, which will then be replaced by non-CE marked medical devices that are improperly…

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- Date for filing MDR files: the text sets the deadlines for filing CE marking applications and issuing an offer by the ON. The procedures for filing the files are not defined: should they be made available to the ON a few weeks before the evaluation or from 2024?

Hello, I am AQ/AR manager of an SME, a manufacturer of DM since 2017. The extension of the transitional period is a good thing, since undertakings with difficulties have been given ‘reasonable’ time for their file to be examined by the NAOs, if they do not have to change their NAO, if their NAO no longer does their D.M. or even if their NAO no longer exists.

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I support the extension of the transition period of Regulation (EU) 2017/745. I work in regulatory assets in medical device software (non in-vitro). Our Notified Body has very long lead times for the product reviewed necessary to obtain a CE marking certificate under MDR (12 to 18 months for a new medical device or a transfer under MDR of an existing dossier).

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Extension is absolutely necessary to ensure that all actors have sufficient resources to fulfil their role profesically. Without this, the accessibility of medical devices for European patients will be severely disrupted, resulting in avoidable care times and deaths.

Filed in French · English published by the European Commission

Hello, an extension of the transitional period is proposed. The causes are known (e.g. overcrowding of notifying bodies). However, it should not be forgotten that Regulation (2017/745) was voted in 2017. There was very much time to implement it, and it was lobbyists/industry who did nothing to achieve the current situation. It is now a bit easy to apply for an extension.

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MDSS GmbH appreciates the solution proposed with extending the transition in order to ease the implementation of the MDR. Being the European Authorized Representative, also, of small and medium size companies sees the struggles with the MDR implementation. Therefore, we would like to comment in a different direction, which would allow all legacy products to enter the MDR process immediately.

The extension of the transitional period until December 2028 (Class IIa medical device) makes it possible to better prepare for the MDR certification process. However, the most critical point of certification is the lack of availability of notifying bodies in Poland. Currently, two notifying bodies are qualified, of which only one of them employs technical experts qualified to assess the technical documentation.

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Congratulations for the propose. The extension of the transition period of the MDR and IVDR is necessary, ant the time is running out. Below some questions/comments to improve the proposal. In our opinion, the application of the amendment proposal of article 120 should be clarified.

Congratulations on the proposal to improve compliance with the new regulations for manufacturers in the process of adapting to MDR. So that it is not unfair, but for manufacturers who have already completed this iria adaptation or for EUDAMED to reflect this, we look forward to the final text.

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This proposal, which follows the presentation of 9/12/2022 to EPSCO, can only be welcomed. The need to extend the transitional period for the application of the MDR beyond 2024 is beneficial and indispensable for manufacturers, NAs and patients.

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I am supporting the extension of the transition period because: Notified bodies do not have the bandwith to assess the conformity in due time and there is a risk of device not anymore available to allow proper medical treatment Manufacturers are focussing on upgrading their techfiles to the modified/new requirements but legacy products which are already demonstrated to be safe and efficient are not actually modified…

(2nd time this advice is posted, the first one posted the 12th January is not visible on the website. Please delete this one if this is duplicate) This proposition of extension solves partially the problem of bottleneck of certification requests by manufacturers. Notified Bodies are doing their best efforts to have adequate resources, but they lack trained human resources.

On the list of Notified Bodies: This postponement will enable the Notified Bodies to: — Carry out all applications from manufacturers, – evaluate all technical files efficiently, – recruit more resources that can evaluate CE marking files.

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Hello Good initiative to extend the grace period, however, it must be ensured that the MDD aurpes certificates of notified bodies can be extended. The guide should be provided for in order to analyse the impact of the regulation on the various articles of the regulation. I am thinking in particular of the delay in affixing UDI or not?

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We believe that with the acceptance of the extension of the transition period for medical devices will be very useful for us, as it will give us time to have our MDR certification without our main medical device being withdrawn from the market, because with the current transition period, our MDD certificate will end in May 2024, and it is a risk for us to be at that time without MDR certification as our MDR file…

Dear, First I want to thank you to permit to give our feedback. Below some questions/ comments : - Harmonization for qualification of product reviewer and recognition at European Level RDM 2017/745 Annex VII §3.2.5 Criteria for qualification of product reviewer is not sufficiently detailed in RDM 2017/745 and subject to the interpretation and not harmonization between NB regarding qualification.

Date of submission of MDR files: the text sets the final dates for applications for CE marking and the resignation of an offer by the ON. The procedures for submitting files are not defined: will they have to be made available to the NAO a few weeks in advance of the evaluation or as early as 2024?

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We believe that manufacturers with certificates that have already expired since May 2021 should be offered an opportunity for reinstatement with the caveats of no significant changes, PMS per MDR etc. In many cases the expiration is unavoidable by any means available to the manufacturer; they may not have had the opportunity for a transition audit yet or may have been unable to find notified body to accept them for…

It seems to us that this extension is necessary given the current situation. In the same way, the situation of blockage that has lasted for more than two years regarding the possible extensions of certificates under MDD makes the development and improvement of existing medical devices more than problematic, we would even say critical.

I am in favour of extending the transitional period of Regulation (EU) 2017/745. I work in regulatory cases in the medical device (non-in-vitro). 1. Our Notified Body has extremely long time to carry out the product examinations necessary to obtain a CE marking certificate under MDR (12 to 18 months for either a new medical device or a transfer of an existing file to MDR).

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I am in favour of an extension of the transition period for the benefit of industrialists, notified bodies and beyond patients. The resources allocated to the MDD/MDR transition are enormous for manufacturers to be able to switch technical files to MDR requirements, but after that the NAOs are not able to follow... it takes between 12 and 18 months to obtain an EC-MDR between the rounds and the review panel.

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HI, in my view, are the reasons why the transition period should be extended: — Impact of the health crisis on businesses: concerns about the “survival” of the activity have hampered the work to comply with the Regulation – Impact of the health crisis on trade undertaken/notified bodies/approach to obtaining the EC – Current difficulties in the availability of notified bodies to carry out audits. Warmly

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We agree with the legislative proposal to amend the MDR with an extension of the Directive Certificates to 31 December 2028 at the latest. However, given the small number of notified bodies, the large number of dossiers to be processed and the review times, it seems complicated to us to get a written agreement signed with a NB before 26 September 2024.

It was time to allow continuity of distribution of existing medical devices. However, the extension period seems to me to be too short. The new medical devices which have to pass through RDM 2017/745 will require significant resources on the part of the Notified Bodies.

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I agree to postpone and actually review the MDR. The impact that this new regulation is having in all the med-tech and european competitive landascape is the following: - most of European and international med-tech company stopped to register innovative solution in Europe because it is too costy and time consuming.

The extension of the transition period for medical devices is certainly necessary given the lengthening of the certification times. We fully endorse the removal of the "sell-off" date, which would only create confusion and sales problems, especially in a long distribution chain.

Some Notify Bodies are not issuing official offer We are dealing and working with two Notify Bodies and we have already received Non-Conformity without an official offer Is the correspondence and activities with Notify Body considered equal to the offer?

In my view, this proposal to amend the two Regulations goes in the right direction. However, as a manufacturer of IVDs, I do not consider it sufficient to remove only the sales deadlines for in vitro diagnostic medical devices under (EU) 2017/746. The lack of notified bodies for the IVDR is, in my view, the biggest problem facing the industry.

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Subject: excepting sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors As proposed it seems sutures etc. legacy devices need to be certified before 31 December 2027. Article 120 amendment with paragraph 3 will increase the load of Notified Bodies. This is contrary to the risk based extension of the MDR.

This extension of the transition period for the MDR is really necessary and expected by all economic operators and by all European publics, however many manufacturers that already had their MDD certificates expired and, did not start their MDR process in Due to the exorbitant costs hitherto presented by the NB's associated with the MDR requirements that are disproportionate to the risks of many products, we…

It is essential to establish how the verification of the implementation of item 120.3.d will be carried out, since the big problem is the lack of Notified Bodies how we can expect that companies will have been audited under Article 10 of the MDR by May 26, 2024 ?

We believe that Rule 11, which leads to almost all medical device software being placed in Class IIa, is an aberration. Extending the transition will not solve the bottleneck for medical device software and ultimately the loss of competitiveness of the EU compared to other medical device markets.

Great initiative for existing products but for innovative new MD to come, it means an issue to be able to be registred before 2026... Europe may lost many European innovative and cost effective MD that will move to USA to launch instead of Europe to find market access... There is a special warning on bioproduction MD as without those, new biotech therapies are not possible.

Dear EU commission, Extension for the transition period of MDR is welcomed for the safety of the patients and people living in the EU. It is vital and critical to ensure that there are enough medical devices on the market. However, what I am lacking in the proposal is ensuring that there are set conditions for the extension (specifically for non-European countries).

This extension is a necessity, it's perfectly summarized in the "Context" part of document 2023/0005 (COD). Nevertheless, the provision of article 120.3.d.e depends on the availability of the notified bodies, which is not guaranteed, they are private companies that manage their activities as they see fit.

Dear, An important subject is not stated in the proposal. What about harmonization of standards? Today, a few of them are harmonized to MDR and as a manufacturer, our NB asks us to justify the use of not yet harmonized. Accorsding to them, we need to prove compliance to GSP by given exact clause of each standard and justify why this complies with GSP? Why should we do job of the EU commission?

The postponement of the deadline is essential. Without the postponement, Europe would lose a significant proportion of good and safe medical devices, because manufacturers would only register their most lucrative product groups with the notified bodies due to the bottleneck. This would greatly reduce the supply of (in particular) niche products, which in turn would endanger patient health.

This proposal doesn't solve the problem of software up-classification with the MDR. The current wording of Rule 11 in Annex VIII of the MDR places almost every SaMD in class IIa. This is confirmed by the MDCG 2019-11 and the Manual on Borderline and Classification V2 of December 2022.

The proposed new dates are too far away and this could interfere with the purpose for which the new regulations were drafted. I believe that it is necessary to give flexibility and help manufacturers but at the same time be strict in complying with the requirements of both regulations in order to ensure that the products on the market are safe.

We are a Manufacturer of Injectable and Topical Devices This extension will help us to complete our clinical studies ongoing and to improve our technical documentation I hope that thanks to this extension all the Manufacturers will be able to improve and reinforce Vigilance and Post Mktg activities on Legacy Devices.

I support the proposed chnages and the timeline. What is missing is are better options for toforce NB to charge less fees for SME, especially start-ups. Same for the SME's , especially start-ups: no facilitations to have immediate access to the expert panels, clear common regulations across Europe on early feasibility clinical studies before performing a large clinical trial to obtain CE mark.

As a representative of medical device manufacturers I strongly support the extension of the transition periods and the cancellation of sell-off periods. My concern lies with short period of just three months between application dead line for conformity assessment by manufacturers (26.5.2024) and the required presentation of the written agreement between them and the notified bodies (26.9.2024).

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