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...
UK – MHRA to launch the AI-Airlock, a new regulatory sandbox for AI developers
The Medicines and Healthcare products Regulatory Agency (MHRA) has announced it is taking forward its new ‘regulatory sandbox’, the AI-Airlock, that will provide a...
Europe – Stakeholders seek short-term fixes, long-term reform for European medtech regulations
Medtech stakeholders say there needs to be a reform of the European medtech regulatory system to improve efficiency, consistency and agility.
Cracks in the current...
