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…
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…
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…
On 3 February 2025, the UK Medicines and Healthcare products Regulatory Agency (MHRA) released a new guidance document to help manufacturers navigate the regulatory landscape…
The European Commission just published an advice on IVDs testing SARS-CoV-2 on request from the Medical Device Coordination Group (MDCG) issued by the IVDR Expert…
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…
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…
On 15 January 2025, the MHRA (Medicines & Healthcare products Regulatory Agency) released a new guidance on PMS requirements for medical devices following the adoption…
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…
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has released Version 2.0 of its Medical Devices Regulatory Reform Roadmap, providing a detailed timeline for…
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.…
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…
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…
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