The EU regulatory environment still sees the release of numerous guidance documents that may help economic operators to implement the requirements for Regulations (EU) 2017/745 and 2017/746 on medical devices or in vitro diagnostic medical devices respectively (MDR and IVDR):
The Medical Device Coordination Group (MDCG) published MDCG 2023-3, Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 on medical devices. The document provides specific advice on how manufacturers should set up their vigilance system and can be seen as a replacement of MEDDEV 2.12-1. Mdi Europa is currently working on a more comprehensive article on that topic. Please note the guidance addresses the MDR requirements. An update is expected for the IVDR. We nonetheless think that the document may generally be very useful also for manufacturers of IVD medical devices.
Notified body bsi published a white paper on dos and don’ts under the IVDR. It is an update to the previously issued document and provides a checklist approach to the different aspects for a successful IVDR implementation.
The notified body association Team-NB published a best practice guidance for technical documentation submissions according to annex II and III of the IVDR. Although the market seems to see the guidance in parts critical, we think it is a valuable support to prepare technical files in accordance with IVDR requirements. It can also be a useful tool for manufacturers of class A IVD medical devices where no notified body involvement is required as the position of notified bodies and competent authorities are often aligned.
The medical technology industry association MedTech Europe issued the third edition of its ebook Clinical Evidence Requirements under the EU In Vitro Diagnostics Regulation (IVDR). The document is a “a collection of questions and answers designed to help manufacturers navigate their performance evaluation obligations under the IVD Regulation 2017/746.”
Should you have any questions or wish to have one of the documents submitted to you, please let us know.
Source: MDCG, bsi , Team-NB
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Browse mdi-europa.com by tag “Guidance Documents“.