Artificial Intelligence and Medical Devices Regulation. Discussing the legal framework and the ethical challenges within the CORE-MD project
Debates in the legislative and policy-making environment on Artificial Intelligence (AI) have gradually concerned the medical device field. Where do AI-based medical devices regulation stand in the EU? This blog post gives a short and non-exhaustive overview of the legal
02/12/22
Biomed Alliance represents 36 biomedical Societies in Europe
Continuing challenges for the implementation of the EU Medical Devices Regulation (MDR…
31/10/22
MDCG guidance document on authorised representatives
Where the manufacturer of a device is not established in a Member State, the device may onlybe…
10/09/22
Within the CORE-MD Consortium, Drs Lotje A. Hoogervorst,MD, PhD student is working with Dr Perla J. Marang-van de Mheen on aggregating insights from r…
07/09/22
In the framework of the annual congress of the European Society of Cardiology (Barcelona, Friday 26 - Monday 29 August), a dedicated session on CORE-M…
29/08/22
Biomed Alliance's survey on availability of medical devices
Further to its June press release, the Biomed Alliance issued a survey to assess whethe…
06/08/22
According to Article 100 of Regulation (EU) 2017/746, the European Commission may designate EU reference laboratories (EURLs) for high-risk in vi…
06/06/22
In the framework of the BioMed Alliance In Vitro Diagnostics (IVD) Task Force, experts on in vitro diagnostic medical devices provided their analysis …
25/05/22
The European Commission issued its Implementing Decision (EU) 2022/757 of 11Â 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 …
