As part of its post-Brexit demarcation from the rest of Europe, the UK has introduced stand-alone Post-Market Surveillance (PMS) regulations that have been integrated into The Medical Devices Regulations 2002. The new requirements apply to Great Britain (GB), comprising England, Scotland and Wales. Northern Ireland will continue to recognise the EU regulations for medical devices,…
The International Medical Devices Regulators Forum (IMDRF) has issued guidance on when and how regulators should share information about the potential postmarket risks of certain medical devices. On 1 April, IMDRF’s National Competent Authority Report (NCAR) Exchange Program Working Group published guidance titled ‘Medical Devices: Post Market Surveillance National Competent Authority Report Exchange Criteria and…
The 9th EAAR Annual Conference on New Medical Device Regulations (RMD 2025) took place in Brussels, Belgium, on 24-25 February 2025, featuring speakers from across the MedTech industry, including regulators and notified bodies. Organized by the European Association of Authorised Representatives (EAAR), the conference serves as an inclusive platform for all stakeholders across the both…
MedTech Europe, together with COCIR and other European industry associations, have published joint papers on two important topics for medical device manufacturers in the context of the forthcoming review of the Medical Device Regulation (MDR, 2017/745). The topics are: Recognition of MDSAP certificates for the purpose of CE marking, and Clinical strategy as part of…
Currently, electronic Instructions for Use (eIFUs) are only allowed for certain types of medical device, e.g.: If they are for professional use and use by other persons is not foreseeable: Implantable and active implantable devices, Fixed installed medical devices and their accessories, and Medical devices and their accessories fitted with a built-in system visually displaying…
MDCG 2019-6 has been revised and reissued as Rev.5, with changes related to ‘structured dialogue’ and ‘leveraging evidence’ being included. The main change has been to add section IV.13, ‘What is considered “Leveraging evidence”?’, which explains that: “notified bodies should avoid unnecessary duplication of work when performing their conformity assessment activities. In this respect, a…
The International Medical Device Regulators Forum (IMDRF) on has finalised two technical documents detailing guiding principles for good machine learning practices (GMLP) and risk characterization for medical device software. The final IMDRF GMLP document lists ten guiding principles for good machine learning practices. The principles include understanding the product’s intended use; implementing good software, design,…
For anyone in the medtech industry seeking up-to-date information relating to the performance of actors within the regulatory sector covering the Medical Device Regulation (MDR, 2017/745) and In Vitro Diagnostics Regulation (IVDR, 2017/746), the on-line dashboard provided by the Austrian National Public Health Institute (Gesundheit Österreich GmbH/GÖG), in collaboration with Areté and Civic Consulting, commissioned…
The US Food and Drug Administration (FDA) finalized guidance to industry on allowable communications to health care providers about off-label drug and device uses. The Q&A document, issued on 6 January 2025, outlines the agency’s enforcement policy for firm-initiated communications to health care providers that contain scientific information on unapproved uses (SIUU) for approved or…
The European Commission has launched a public consultation seeking stakeholder input on the effectiveness of the EU Medical Devices Regulation (MDR, 2017/745) and the In Vitro Diagnostic Medical Devices Regulation (IVDR, 2017/746) in a targeted evaluation. An announcement stated that the evaluation will help the Commission “take stock” and assess the effectiveness, efficiency, and proportionality…
