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...
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...
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...
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...
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...
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...
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...
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...
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...
