Opinion On Allergy Alert Test (AAT) as a proof-of-concept study

Europe – MDCG 2023-6 Guidance on demonstration of equivalence for Annex XVI products :...

The Regulation (EU) 2017/745 on medical devices, hereafter referred to as the MDR (medical device regulation), provides a possibility to use clinical data related...

Europe – CAMD Statement – 50th CAMD Plenary meeting

In the context of the French Presidency of the EU Council, during its 50th plenary meeting, CAMD adopted a statement, following discussions about transition to...

UK- Wearable technology to be offered to thousands with type 1 diabetes in UK

The condition affects around 270,935 people in England and 16,090 people in Wales. The National Institute for Health and Care Excellence (NICE) has published final...

Europe – Commission proposes measures to improve the availability of in vitro diagnostics

Today, the European Commission is proposing more time for companies to apply the In Vitro Diagnostic Medical Devices Regulation (IVDR), under certain conditions. With this...

Europe – La prolongation de la période de transition pour les dispositifs médicaux et...

L’amendement qui modifie les Règlements (UE) 2017/745 et (UE) 2017/746 en ce qui concerne les dispositions transitoires relatives à certains dispositifs médicaux (DM) et...

Europe – Artificial Intelligence Act : un nouveau règlement européen à suivre de près

L’AIA est une proposition de règlement du parlement et du conseil européens dévoilée le 21 avril 2021, dont l'entrée en vigueur est programmée dans...

Europe – Euro Roundup: European Commission proposes streamlining regulations to boost biomanufacturing

The European Commission is set to assess how to streamline regulatory pathways for the biotechnology and biomanufacturing sector as part of a broader push...
MHRA Offers Grace Period for Device Manufacturers Dealing With Withdrawn Notified Bodies

UK – Medical devices: EU regulations for MDR and IVDR (Northern Ireland)

This guidance provides information on the EU Regulations for medical devices (MDR) and in vitro diagnostic medical devices (IVDR). From 1 January 2021 the Medicines and Healthcare...

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 – Votre avis sur l’extension de la période de transition des RDM et...

La Commission européenne va soumettre au Parlement européen et au Conseil une proposition d'amendement modifiant les règlements (UE) 2017/745 (RDM) et (UE) 2017/746 (RDMDIV) en ce...

NOS PROCHAINES FORMATIONS