The Romanian implementation laws of the MDR (Emergency Ordinance no. 46 of 9 June 2021) and of IVDR (Emergency Ordinance no 137 of 12 October…
EMA advice on high-risk medical device clinical development
The European Medicines Agency (EMA), in collaboration with the European Commission, has established a standard procedure for manufacturers of certain high-risk medical devices to request…
EU clinical investigations and performance evaluations pilot project
In February 2025, the European Commission and Member States have launched a pilot program for coordinated assessments of clinical investigations and performance studies under EU…
2025 deadlines for medtech in the EU, UK, and Switzerland
2025 brings crucial regulatory deadlines for the medtech sector across the EU, UK, and Switzerland. Some of the key dates and requirements that a manufacturer…
Removability and replaceability of portable batteries in medical devices
The EU Battery Regulation 2023/1542 applies to all batteries in the EU, including batteries incorporated into or added to medical devices and IVDs. The Regulation…
UK Regulations on Post-market Surveillance Requirements
On 15 January 2025, the MHRA (Medicines & Healthcare products Regulatory Agency) released a new guidance on PMS requirements for medical devices following the adoption…
Initiatives to reform MDR and IVDR
Since the Medical Devices Regulation (MDR) and the In-vitro Medical Device Regulation (IVDR) came into full force, several individuals and associations have raised concerns regarding…
Public Consultation on EU MDR & IVDR is now open
On 12 December 2024, the European Commission launched a feedback period for a targeted evaluation of EU regulations on medical devices and in vitro diagnostics.…
Q&A and form for notification obligation for supply interruption or discontinuation
From 10 January 2025, manufacturers of medical devices and in vitro diagnostics (IVDs) must notify the relevant competent authorities and economic operators of any interruptions…
Guidance on clinical investigation reports in EUDAMED absence
MDCG 2024-15 is the first guidance document published by the Medical Device Coordination Group in December 2024. This document provides instructions on how to submit…