EUCOPE News by Category — News

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News - February 11, 2020

Fair competition for SMEs – Letter to DG SANTE

Following the application of the new organisation of the European Commission’s DG SANTE, EUCOPE took the opportunity to send a letter to Ms Anna-Eva Ampelas, recently appointed as Head of Unit B6 on Medical Devices, to outline our concerns on the implementation status of the… read more

News - January 7, 2020

Guidance on Cybersecurity for Medical Devices

The European Commission published this 06 January its guidance on cybersecurity for Medical Devices. The document, fruit of a long consultation with stakeholders including EUCOPE, provide manufacturers with guidance on how to fulfil all the relevant essential requirements of Annex I to the MDR and… read more

News - November 28, 2019

MDR: Second Corrigendum aims at Class 1 Devices

The Council of the European Union has published a second set of corrections as part of a corrigendum for the EU’s Medical Devices Regulation (MDR), this time giving manufacturers of certain Class I devices an additional four years to comply. With this corrigendum, all Class… read more

News - November 18, 2019

EMA Regulatory Science Strategy: Our Proposals

As the European Medicines Agency (EMA) is convening stakeholders (including a EUCOPE delegation) for a two-days workshop to brainstorm on its Regulatory Science Strategy 2025, please read our latest blog piece detailing our priorities and proposals for a more integrated and collaborative regulatory framework.