News - January 23, 2020

EJP RD – Networking event for interested parties

On the 3rd of March, in Paris, France, the Rare Diseases Research (RDR) initiative will organise a networking event for SMEs, academia and interested stakeholders to take part in research project targeting specific rare diseases challenges. Within the framework of… 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… 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…. 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… read more

News - November 7, 2019

Medical Devices: 2 New Notified Bodies ready for MDR

With 6 months to go before the application of the Medical Devices Regulation (MDR), the European Commission is putting pedal to metal in the implementation process! Two new Notified Bodies have indeed been recently designated to operate under MDR from… read more