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Medical device manufacturers doing business in the European Union (EU) will want to review the most recent version of the MDCG 2019-6 Questions and Answers (Q&A) document, which represents the most significant update to date, with five updated Q&As, two replacement Q&As, and one new Q&A. Of particular interest in this update, Question I.6 (Q I.6) concerns whether notified bodies would be able to..

Introduction Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) establishes the requirements for notified bodies involved in the conformity assessment of applicable classes of in vitro diagnostic medical devices (IVDs). Manufacturers must demonstrate that the devices conform to relevant requirements based upon objective evidence and analysis. In accordance with these conformi..

▶ Introduction The Regulation (EU) 2017/745 on medical devices, hereafter referred to as the MDR (medical device regulation), provides a possibility to use clinical data related to an equivalent device in the clinical evaluation required for a device under conformity assessment. Whilst carrying out a clinical investigation is the most direct way to generate clinical data concerning the safety an..

The RAPS Convergence 2023 concluded on 5 October 2023. For a few glorious days, professionals convened in Montreal, Canada to discuss all aspects regulatory. One topic discussed extensively covered notified bodies and the European Medical Devices Regulation (2017/745, MDR). Notified bodies have been working to harmonize their activities. Notified body representatives have attended meetings and a..