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The European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) represents small to mid-sized innovative companies in pharmaceuticals, biotechnology, and medical technologies across Europe. EUCOPE welcomes the European Commissions initiative to revise the MDR and IVDR to ensure a more predictable, proportionate, and innovation-friendly framework.

EUCOPE welcomes the European Commission's targeted revision of the Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), recognising it as a timely opportunity to improve predictability, reduce unnecessary regulatory burdens, and strengthen Europe's competitiveness.

AbbVie welcomes the Commissions targeted revision of the MDR/IVDR and appreciates the intent to update Regulation (EU) 2017/745 based on practical experience and broadly supports many of the Commissions proposals. These proposals introduce important measures to support innovation and improve regulatory efficiency, however, there is room for further improvement on several aspects.

As a research-driven biopharmaceutical company, AbbVie supports the Commission objectives to create a patient-centered and globally competitive European pharmaceutical policy environment that enhances the availability of medicines across the EU and incentivizes development of treatments for unmet health needs in both diseases where no treatments exist as well as those where the existing treatments do not…

EUCOPE is the voice of small to midsize innovative companies active in the field of pharmaceuticals and medical technologies at the European level. The COVID-19 pandemic has again made the vital importance of the European pharmaceutical sector apparent, and while regulatory simplification is welcomed, broader business incentives should also be considered to address the EU’s competitiveness.

EUCOPE acknowledges the objectives of the review. While numerous regulatory provisions will streamline the functioning of the market, changes to the incentive framework outweigh these, weakening EU global competitiveness.

EUCOPE acknowledges the objectives of the Pharmaceutical Package, and welcomes maintaining a separate Directive and Regulation for decentralized and central approval processes. While we appreciate streamlining and digitisation of regulatory procedures, we are concerned that other proposed provisions will undermine R&D, innovation, EU competitiveness, and be particularly detrimental for patients and small and…

As an innovative biopharmaceutical company with over 11.000 employees in the EU, AbbVie supports the Commission’s aims to develop more medicines for unmet needs, speed access to new therapies for all EU citizens, and ensure the maximum benefits from scientific and technological advances.

EUCOPE’s represents 130 small to medium-sized companies playing a key role in the European pharmaceutical environment, many focused on rare diseases. Some of them have unique profiles due to their highly specialised product portfolio, no or limited revenues to date and/or significant risky R&D investments.