The European Medicines Agency (EMA) recently issued a new guidance following the COVID-19 outbreak, to help clinical trials sponsors in adjusting their management of trials and participants during the pandemic. The guidance covers how to deal with, for example, the self-isolation or quarantine of trial participants,… read more
The European Commission announced on 25/03/20 that it will work to propose to the postponement of the implementation date of the Medical Devices Regulation (2017/745 – MDR). In light of the fight against COVID-19 and its numerous consequences on the healthcare systems and all actors,… read more
EUCOPE and its member companies are closely monitoring the COVID-19 situation and its potential impact on the manufacturing and distribution of medicinal products. EUCOPE is reporting any expected shortages or distribution problems due to the COVID-19 outbreak and/or current cross-border restrictions put in place by… read more
EUCOPE asks the European Commission to put research at the heart of its Pharmaceutical Strategy The European Commission’s Pharmaceutical Strategy for Europe must: Provide ambitious measures to foster research in rare diseases and other disease areas for which we currently have no cure. Harness the… read more
On Rare Diseases Day, EUCOPE is delighted to host an interview with Laurence Woollard, patient expert and rare disease advocate, to discuss with him the importance of an engaged community and the opportunities and challenges new treatments can bring. See Laurence’s Q&A on our blog.
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
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 the European Joint Programme on… read more
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
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
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.