Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) - updated information

Switzerland – New organisational structure with separate Medical Devices Surveillance Sector

For the strategy period 2023-2026, Swissmedic’s objectives include making legal responsibilities for medical devices more visible and stepping up international collaboration in this area....

UK – Heart vests to identify those at high risk of sudden cardiac death

In the UK, heart rhythms affect around two million people and can cause sudden death. A re-useable heart vest developed by researchers from University College...

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 – The clock is ticking – MedTech Europe’s recommendations ahead of May 2025...

Class D IVDs are critical for public health. They mainly fall into two categories: a) those related to blood, cells, tissues or organ screening,...

Europe – Questions & Answers for applicants, marketing authorisation holders of medicinal products and...

This Question and Answer (Q&A) document provides practical considerations concerning the implementation of the medical devices and the in vitro diagnostic medical devices regulations. This...
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...
Opinion On Allergy Alert Test (AAT) as a proof-of-concept study

Europe – MDCG 2023-5 – Guidance on qualification and classification of Annex XVI products...

The Regulation (EU) 2017/745 on medical devices, hereafter referred to as the MDR, is applicable to the groups of products without an intended medical...

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...

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