All Regulation (EU) 2017/745 articles
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JournalEU MDR implementation – what is changing for the medical device industry?
Regulatory Rapporteur February 2024 | Volume 21 | No.2 Abstract This article focuses on the impact of the Medical Device Regulation (MDR) transition extension period and provides guidance for medical device manufacturers on the new Regulation (EU) 2023/607. ...
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JournalIVDs and medical devices — post-market surveillance and clinical follow-up requirements
Written by Kirsten Van Garsse from Qarad (part of the QbD Group) based on an online seminar presentation, made in collaboration with TOPRA and QbD, given on 6 December 2022 by Kirsten Van Garsse and Anne-Sophie Grell from QbD.