News - February 28, 2020
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.
News - February 11, 2020
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 23, 2020
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
News - January 7, 2020
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
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
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.
News - November 7, 2019
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 May 2020. The two entities,… read more
News - October 14, 2019
The 10th World Orphan Drug Congress is taking place 12th–14th November, 2019 in Barcelona, Spain. Established as one of the largest and most established European orphan drug event, the event will propose an exciting speakers line-up and agenda covering the whole orphan drug landscape. The 12th… read more
News - October 2, 2019
Earlier this month, the European Commission published the outcome of an evaluation of the fee system of the European Medicines Agency (EMA) together with an Inception Impact Assessment (which can be downloaded here). The latter outlines three different options on how the EMA fee system… read more
News - September 26, 2019
The Czech Ministry of Health recently announced that the Public Health Insurance Act 48/1997, which regulates the scope and conditions under which health services are covered as well as their pricing and reimbursement, would be amended. The foreseen amendments, expected to enter into force in… read more
