EUCOPE Resources / News - April 11, 2023
Sounds of Science Podcast – Episode 15 MDR/IVDR: Recent changes and their implications for EU medical device companies and patients The EU’s Medical Device Regulation (MDR) came into full effect on 26 May 2021 and was followed by the In Vitro Diagnostic Device Regulation (IVDR)… read more
News - March 17, 2023
The European Medicines Agency (EMA) has launched a pilot to give scientific advice on the intended clinical development strategy and proposals for clinical investigation for certain high-risk medical devices (all class III devices and class IIb active devices intended to administer and/or remove medicinal product(s)). As of… read more
News - January 23, 2023
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
EUCOPE Resources / News - July 1, 2022
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
News - April 28, 2020
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
News - March 26, 2020
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
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 - August 14, 2019
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
News - July 1, 2019
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
News - May 24, 2019
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
