COCIR

COCIR members are and have been dedicated to advancing a circular economy in the medical devices sector for years. Through the reuse and refurbishment of parts and equipment, we aim to minimize waste, conserve raw materials, and reduce energy consumptions.

COCIR welcomes the Commission proposal for a targeted revision of the Regulation (EU) 2017/745 and supports its overarching objectives: maintaining a high level of patient safety and public health, while reducing unnecessary administrative burden, improving the predictability and cost-efficiency of conformity assessment, strengthening digitalisation, and international cooperation.

COCIR welcomes the attention raised by the European Commission on the shortcomings in the implementation of Regulation (EU) 2017/745 (the Medical Devices Regulation, MDR). We commend the European Commissions intention to table a legislative proposal by end of 2025 to reduce the administrative burden, enhance the predictability and cost-efficiency of the certification processes of Notified Bodies, streamline…

COCIR is the European Trade Association representing the medical imaging, radiotherapy, health ICT and electromedical industries. Founded in 1959, COCIR is a non-profit association headquartered in Brussels (Belgium) with a China Desk based in Beijing since 2007.

COCIR is the voice of the European manufacturers of medical imaging, radiotherapy, health ICT and electromedical industries. COCIR welcomes the opportunity to present its views on Regulation (EU) 1025/2012 on standardisation in response to the European Commissions Call for evidence for an Impact Assessment launched on 23 June 2025. COCIR believes that Regulation (EU) 1025/2012 remains fit for purpose.

COCIR welcomes the European Commissions Digital Fitness Check as an opportunity to assess how EU digital legislation interacts with existing sectoral frameworks and how this interaction affects innovation, competitiveness, and the functioning of the Single Market. First, the Digital Fitness Check should ensure stronger coherence between horizontal digital legislation and sector-specific regulatory frameworks.

On behalf of the Company/Business organizations/Business associations listed in the attached document, participants in the RoHS Umbrella Industry Project (the Umbrella Project). The Umbrella Project contribution to the consultation is attached as a pdf document.

COCIR welcomes the draft Commission Implementing Regulation on the uniform application of requirements for notified bodies as a timely and necessary step. The objective of the proposed measures to increase predictability of conformity assessments will foster higher competitiveness of the EU regulatory framework, while ensuring patient safety.