MHRA Offers Grace Period for Device Manufacturers Dealing With Withdrawn Notified Bodies

UK – MHRA launches public consultation on future of medical device regulation

Launched today by the Medicines and Healthcare products Regulatory Agency (MHRA), the 10-week consultation gives everyone the opportunity to draw on their own experiences...
As coronavirus roils region, EU device body adamant about steps to hit MDR deadline

Europe – European IVDR application partially postponed

The European Commission has proposed delaying compliance deadlines for the In-vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR), which would allow some manufacturers more...
CLASSIFICATION DES DM : Comparaison DDM/RDM

Europe – IVDR: Commission proposes to delay implementation amid ‘grave’ notified body shortage

Amid concerns of a market collapse and a "grave shortage" of notified body capacity, the European Commission on Thursday proposed to delay the implementation...
Eudamed : un report de 2 ans à mettre à profit pour mieux se préparer au RDM

Europe – Eudamed update: Additional data entry modules now online for European medical device,...

EUDAMED is the IT system developed by the European Commission to implement Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnosis medical devices. The...

Europe – MDCG 2021-24 : Guidance on classification of medical devices

The classification of medical devices in use by the EU medical device legislation is a risk-based system taking into account the vulnerability of the...
Advice for Management of Clinical trials in relation to Coronavirus

UK – Borderlines with medical devices and other products in Great Britain

This document gives help in working out if your product is considered to be a medical device under UK legislation...
MHRA Offers Grace Period for Device Manufacturers Dealing With Withdrawn Notified Bodies

UK – MHRA shares guidance on need to review registration of medical devices

MHRA has told medical device manufacturers to review their registration information “frequently” to ensure it is up to date. The agency provided the advice...
Advice for Management of Clinical trials in relation to Coronavirus

UK – Transforming the regulation of software and artificial intelligence as a medical device

These measures demonstrate the UK’s commitment, following our exit from the European Union, to drive innovation in healthcare and improve patient outcomes. The exciting and...
MHRA Offers Grace Period for Device Manufacturers Dealing With Withdrawn Notified Bodies

UK – MHRA launches public consultation on future of medical device regulation

Launched today by the Medicines and Healthcare products Regulatory Agency (MHRA), the 10-week consultation gives everyone the opportunity to draw on their own experiences...
As coronavirus roils region, EU device body adamant about steps to hit MDR deadline

Europe – IVDR watch: IVD Expert Panel now accepting submissions for performance evaluation consultations

The European Expert Panel established to provide scientific and technical expertise regarding in vitro diagnostic (IVD) devices under the In-vitro Diagnostic Medical Devices Regulation...

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