All Medical Device Regulation articles
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EditorialVeterinary medicines: the challenges of new regulation
Regulatory Rapporteur October 2023 | Volume 20 | No.9 The October 2023 edition of TOPRA’s journal – Regulatory Rapporteur – focuses on topics and developments specific for veterinary medicines: From the challenging aspects arising ...
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JournalRegulatory challenges and opportunities facing hearing aid manufacturers in Europe
In a world where many people are living longer but not all are living well and age-related hearing loss affects approximately 20% of the European population aged 65 or older – hearing aids address a medical need which for the most part remains unmet. With increasing evidence ...
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JournalOne year experience on EU Medical Devices Regulation (MDR) 2017/745 for single integral drug-device combination products
Since 26 May 2021, Article 117 of the MDR asks for a notified body opinion (NBOp) to be included in the marketing authorisation applications (MAAs) for medicinal products that are a single integral drug-device combination.
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FocusPractical insights into the recent EU MDR framework
This article focuses on the impact of the new guidance document on drug-device combination (DDC) products, in Article 117 of the European Medical Device Regulation (MDR) for pharmaceutical marketing authorisation holders (MAHs). It explores the new role of the notified body (NB) versus the MAH pertaining to the device part of the DDC, some of the pitfalls encountered by pharmaceutical MAHs and potential solutions to efficiently navigate the new framework. It also provides practical insights into key technical requirements for the product-specific quality aspects of a medical device, which are within the quality dossier of a successful EU application. The article also explores efficient global implementation within fast evolving and at times divergent, regional regulations.
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Meeting ReportMD2: Global development strategy, which market should you go to first?
Michelle Lotte started the session. She summarised considerations of the MDD/MDR transition against submission to the FDA.