As previously outlined in the EPSCO Council (Health) meeting on 9 December 2022 (Information Note), the European Commission adopted draft legislation on 6 January 2023 amending Regulations (EU) 2017/745 (Medical Devices Regulation – MDR) and (EU) 2017/746 (In Vitro Diagnostics Regulation – IVDR) as regards the transitional… read more
The objective of this survey is to capture the consequences of the Medical Devices Regulation (MDR) on innovative European companies, including those that have received significant government money. We expect that a contradiction could emerge between the massive investment done by the EU and Member… read more
On 3 April, the European Commission adopted a proposal to postpone by one year the application of the Medical Devices Regulation (MDR). Following adoption by the European Parliament on 17 April, the proposal was adopted by the Council on 22 April. The amending Regulation 2020/561… 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
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
The European Commission is calling the European Committee for Standardization (CEN) and the European Committee for Electrotechnical Standardization (CENELEC) to propose revision to current standards and new ones to be in line with the coming Medical Devices and In Vitro Diagnostics Regulations’ requirements. The requested… read more
With almost one year to go before the implementation of the Medical Devices Regulation (MDR) 2017/745, the Brussels-based edition of Politico reports on the main problems for related stakeholders, whilst the European Commission is scrambling to get things in order before May 2020. Representing EUCOPE… read more
Following the last Medical Devices Coordination Group (MDCG)-Stakeholders’ meeting of 14 February, the European Commission (EC) updated the ‘Rolling Plan’ containing the list of essential implementing acts and actions for the transitional period as well as information on expected timelines and state-of-play of the coming… read more
Following the last Medical Devices Coordination Group (MDCG)-Stakeholders’ meeting, the European Commission (EC) published a ‘Rolling Plan’containing the list of essential implementing acts and actions for the transitional period as well as information on expected timelines and state-of-play. As highlighted in the plan, the EC… read more
Keep up-to-date on all of the most pertinent policy files and regulatory news around the world of European health technologies with our monthly newsletter – the Innovation Eye-View