Experts’ views and analysis on the challenges of IVDR
In the framework of the BioMed Alliance In Vitro Diagnostics (IVD) Task Force, experts on in vitro diagnostic medical devices provided their analysis on the challenges of IVDR. Several experts are also CORE-MD partners.
With the implementation of Regulation (European
25/05/22
The European Commission issued its Implementing Decision (EU) 2022/757 of 11 May 2022 amending Implementing Decision (EU) 2021/1182 as regards harmon…
18/05/22
A new survey was launched by CORE-MD partners, aiming to assess educational needs of clinicians, notified bodies and regulators related to regulatory …
15/05/22
Participants in CORE-MD Project Board Meeting - Leiden 25-26 April 2022
Members of the CORE-MD consortium met recently for the first time in person…
13/05/22
RAPS meeting in Amsterdam - 12 May 2022
CORE-MD project was presented at the Regulatory Affairs Professionals Society in Amsterdam. Euro Convergenc…
17/04/22
A new legislative framework on medical devices, comprising Regulation (EU) 2017/745 on medical devices (MDR)1 and Regulation (EU) 2017/746 on in vitro…
02/03/22
The regulation reinforcing EMA’s role in crisis preparedness and management of medicinal products and medical devices becomes applicable as of 1 March…
18/02/22
Held in Madrid on 6-7 February 2022, the 6th EUCROF Congress “Clinical Trials in a New Era” proved to be an important forum to discuss changes which c…
01/02/22
Under the leadership of the Department of Cardiology, Bern University Hospital, CORE-MD partners work on a protocol for a systematic review to critica…
27/01/22
CORE-MD work package and task leaders got together online on 21st January 2022 fostering synergies between the CORE-MD researchers. This meeting aimed…
