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 – 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...
UK – MHRA expected to launch recognition framework for devices
According to Richard Phillips, executive director of the Association of British HealthTech Industries (ABHI), the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is...
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...
Europe – MDCG 2022-19 Performance study application/notification documents under Regulation (EU) 2017/746
The sponsor of a performance study is required to submit an application/notification1 to the Member State(s) in which a performance study is to be...
Europe – Questions and Answers: Commission proposes an extension of the transitional periods for...
The EU rules on the safety and performance of medical devices were created in the 1990s. In April 2017, the European Parliament and the...
Europe – European Commission Publishes Directive on the Liability of Artificial Intelligence Systems
On September 28, 2022, the European Commission published its long-promised proposal for an AI Liability Directive. The draft Directive is intended to complement the...
