Europe – New Swiss IVD regulations come into force as EU mutual recognition agreement...
A mutual recognition agreement (MRA) aligning in vitro diagnostic (IVD) regulations between the European Union and Switzerland has officially expired following the In Vitro...
UK – MHRA and NICE awarded £1.8m to explore regulation of digital mental health...
The healthcare sector has seen a considerable increase in the number of digital mental health tools made available in recent years. Despite this improvement...
Europe – MDR transition delay needs clarification, industry engagement to succeed
Whether the new proposal from the European Commission to delay the EU Medical Device Regulation (MDR) transition period works out will depend on the...
Europe – Euro Convergence: Experts call for more IVD-specific guidance during IVDR transition
Notified body representatives say that when regulators develop guidance for the In Vitro Diagnostics Regulation (IVDR) they need to get more input from IVD...
Europe – IMDRF: Medical Devices: Post Market Surveillance National Competent Authority Report Exchange Criteria...
This document was developed by the IMDRF National Competent Authority report (NCAR) Exchange Program Working Group as an update to the original document (N79)...
Italy – The New Italian Sunshine Act: What Companies Should Know And How To...
On 31 May 2022, the Italian Parliament approved Law 62/2022, also known as the Sunshine Act. The Sunshine Act entered into force on 26...
Europe – European Notified Body survey: MDR, IVDR certification numbers remain low
A new survey from the European Commission shows that many medical device and in vitro diagnostic (IVD) manufacturers have yet to apply for certification...
Europe – European Parliament votes to extend MDR transition period
The European Parliament on Thursday voted overwhelmingly to extend the Medical Devices Regulation (MDR) transition periods to avoid a shortage of life-saving products in...
Europe – MDCG 2022-8 Regulation (EU) 2017/746 – application of IVDR requirements to ‘legacy...
Regulation (EU) 2022/1121 extended the transitional provisions of Regulation (EU)
2017/746 on in vitro diagnostic medical devices (IVDR), in particular its Article 110(3),
in terms of...
Europe – New European Manual on Borderline and Classification for medical devices and IVDs...
Determining whether a given product falls under the definition of a medical device and the
application of the classification rules fall within the competence of...
