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COMPANY NEWS

Maria Donawa spoke at the 9th EAAR Annual Conference on 24-25 February 2025

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…

Clinical Data Requirements: EU vs. US – Critical Differences and Strategies

On 25 September 2024, Donawa Lifescience President Dr. Maria E. Donawa spoke at the webinar titled ‘Clinical Data Requirements: EU vs. US – Critical Differences and Strategies’. Dr. Donawa was joined as a speaker by Tom Melvin, Associate Professor of Medical Device Regulatory Affairs, Trinity College, Dublin. The webinar was hosted by MedTech Leading Voice…

Maria Donawa posts a second article on device clinical evaluation plans on LinkedIn

Donawa Lifescience President, Maria E. Donawa, M.D., has authored a second ‘Regulatory Recap’ article on LinkedIn covering interpretational difficulties with requirements for Clinical Evaluation Plans (CEPs) under the EU Medical Device Regulation (MDR, 2017/745) titled: ‘CEPs: What Does “State of the Art” Modify?’ The topic arises because of confusion among manufacturers, notified bodies, and competent…

Global News

UK introduces new PMS regulation for Great Britain

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,…

New IMDRF guidance covers postmarket surveillance report sharing

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…

European industry provides opinions on two important topics: MDSAP and Clinical Strategy

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…