Europe – Nouveau Organisme notifié au titre du Règlement (UE) 2017/745

Nouveau Organisme notifié au titre du Règlement (UE) 2017/745
Norway’s DNV GL Designated as 10th Notified Body Under MDRClinical Trials With Conditions

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...
Practical guidance for procedures related to Brexit for medicinal products for human and veterinary use within the framework of the centralised procedure

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...
DEKRA accredited under the MDR

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
As coronavirus roils region, EU device body adamant about steps to hit MDR deadline

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...
MHRA Offers Grace Period for Device Manufacturers Dealing With Withdrawn Notified Bodies

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...
As coronavirus roils region, EU device body adamant about steps to hit MDR deadline

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...
Could AI Become the New Quality Control Manager in Medical Device Manufacturing?

Europe – Experts outline current knowledge on AI and medical devices

With European legislation on how to regulate the integration of artificial intelligence (AI) into daily life on the horizon, it’s time to consider how...

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