EUCOPE, the European association for small to medium-sized companies active in pharmaceuticals and biotechnologies – many of which are researching and developing rare disease treatments – notes the publication of the European Commission Communication on the Pharmaceutical Strategy for Europe. EUCOPE calls for a comprehensive Pharmaceutical Strategy… read more
In the follow-up of Commission President von der Leyen’s intention to shape a resilient European Health Union, the Commission services announced on 11 November the publication of a Communication on Building a European Health Union: Reinforcing the EU’s resilience for cross-border health threats accompanied by… read more
The European Commission just opened the public consultation on its proposed pharmaceutical strategy for the EU. In the Commission’s words, the strategy intends to ‘address the current issues of access, availability and affordability of medicines, while still promoting sustainable innovation and support EU industry to… read more
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
The European Commission just published a FAQ document on the new Unique Device Identification (UDI) system, as introduced by the two new Regulations on Medical Devices (2017/745) and In Vitro Diagnostics Devices (2017/746). The document spells out the objectives of this new system, namely to… read more
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