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 14, 2023
On 7 March, the Council of the EU has officially adopted the amendment to the MDR and IVDR. This follows the positive vote from the European Parliament last month and paves the way for the formal signature of the legislative text, which is scheduled for… 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 / Press Releases - April 27, 2021
The Genomics Working Group is made up of advanced diagnostics companies that have come together to ensure Europe will be able to draw benefit from the significant advances that have been made in genomic testing. The group aims to facilitate a dialogue around these technologies… 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 - 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
