Europe – MDCG 2025-6 – FAQ on Interplay between the Medical Devices Regulation &...
This document provides a first set of answers, that will be continuously developed
and updated, to the most frequently asked questions related to the joint...
Europe – MDCG 2025-5 Questions & Answers regarding performance studies of in vitro diagnostic...
This document is intended for sponsors of performance studies of in vitro diagnostic
medical devices (IVDs) conducted within the scope of the Regulation (EU) 2017/746
(IVDR)....
Europe – Update MDCG 2019-11 rev.1 – Qualification and classification of software – Regulation...
This document, which primarily targets Medical Device Software (MDSW) manufacturers,
provides guidance on:
the criteria for the qualification of software falling within the scope of...
UK – First major overhaul of medical device regulation comes into force across Great...
From today (16 June 2025), a landmark reform of how medical devices are regulated in Great Britain takes effect, as part of the Medicines...
Europe – MDCG 2025-4 Guidance on the safe making available of medical device software...
Software Applications (Apps) are significantly changing our way of living, helping in various
aspects of our daily lives, including healthcare. Medical device software (MDSW) Apps...
UK – MHRA releases spate of new guidelines on decentralized manufacturing
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Tuesday released six guidelines to clarify expectations and support the new regulatory framework for...
Europe – EU plan would limit Chinese device makers in Europe
European Union member states this week voted to support a plan to adopt measures that would restrict Chinese medical device makers’ access to the...
Europe – Study supporting the monitoring of the availability of medical devices on the...
Commissioned by: The European Commission’s Directorate-General for Health and Food
Safety (DG SANTE) via the European Health and Digital Executive Agency (HaDEA)
• Aim: To support...
UK – The Medical Devices (Amendment) (Great Britain) Regulations 2025 (Draft)
The Secretary of State in exercise of powers conferred by sections 15(1), 16(1)(a), (b), (c), (e), (g) and (i),17(1)(b) and (c) of the Medicines and Medical...
Europe – MIR PDF 7.3.1 New MIR form – mandatory as from November 2025
The Manufacturer Incident Report (MIR) Form v7.3.1 is the official European Union template used for reporting serious incidents involving medical devices under the MDR/IVDR...
