Europe – Update – MDCG 2021-6 – Rev.1 – Regulation (EU) 2017/745 – Questions...
This document is intended for sponsors of clinical investigations of devices conducted within
the scope of the Regulation (EU) 2017/745 (MDR). This document may be...
Europe – Designation of EU reference laboratories for high-risk in vitro diagnostic medical devices
On 5 December 2023, the European Commission adopted an implementing act designating 5 EU reference laboratories (EURLs) in the field of in vitro diagnostic medical devices...
Europe – MDCG raises alarm over lack of MDR, IVDR applications
The European Commission’s Medical Device Coordination Group (MDCG) is telling medtech manufacturers to get certified under the new device and diagnostics regulations as soon...
Europe – Nouveau Organisme notifié au titre du Règlement (UE) 2017/745
Nouveau Organisme notifié au titre du Règlement (UE) 2017/745
USA – Medtech expert says EU’s AI Act could face an uphill political battle
If the EU is unable to pass a hotly anticipated artificial intelligence/machine learning (AI/ML) law by year’s end, it may face an uphill battle...
Europe – The Future of Europe’s Medical Technology Regulations
MedTech Europe and its members fully support the objectives of the medical technology regulations, In Vitro Diagnostic Medical Devices Regulation 2017/746/EU (IVDR) and Medical...
Europe – Notified Bodies Survey on certifications and applications (MDR/IVDR)
To support monitoring and analyzing the availability of medical devices on the EU
market in the context of the implementation of medical devices and in...
Europe – Un nouveau organisme notifié au titre du règlement (UE) 2017/746
Un nouveau organisme notifié au titre du règlement (UE) 2017/746
Europe – 40ème organisme notifié au titre du règlement (UE) 2017/745
40ème ON notifié au titre du règlement 2017/745
Europe – Notified body perspective: Evaluating uses for real-world data
Real-world data (RWD) can provide useful information that may be included in clinical data submissions, but the greatest value may be during the postmarket...
