UK – UK regulator MHRA to raise medical device registration and other fees by...
The UK Medicines & Healthcare Products Regulatory Agency (MHRA) has published a consultation for industry comment regarding a proposed increase in fees the agency...
Europe – MDCG 2023-4 Medical Device Software (MDSW) – Hardware combinations
Software has become an increasingly important part of the medical device landscape. It is
estimated that one in four medical devices either incorporate medical device...
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 announces consultation on improved safety for high risk in vitro diagnostic...
IVD devices are used to examine samples taken from the human body and to diagnose and monitor health conditions. For example, devices can determine...
Europe – Notified bodies concerned with lack of MDR/IVDR applications as deadlines approach
Notified body (NB) capacity has risen significantly in recent years as the number of designations has increased; however, some manufacturers have yet to transition...
Europe – Ongoing consultations under the PECP
This page lists the views provided by the in vitro diagnostics expert panel under the Performance Evaluation Consultation Procedure (PECP) according to Article 48(6)...
UK – MHRA announces a proposed framework for international recognition of medical devices
The Medicines and Healthcare products Regulatory Agency (MHRA) has today (21 May 2024) published a statement of policy intent for international recognition of medical devices.
The MHRA’s...
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...
Europe – The Future of Europe’s Medical Technology Regulations
MedTech Europe and its members fully support the objectives of the medical technology regulations, In Vitro Diagnostic Medical Devices Regulation 2017/746/EU (IVDR) and Medical...
Europe – Best Practice Guidance for the Submission of Technical Documentation under Annex...
This best practice guidance document has been developed by members of Team NB who have reviewed the best practice guidance documents submitted by individual...
