New Guidance On The European Medical Devices And In Vitro Diagnostic Medical Devices Regulations

Author:Bonnie Clemence and Jacqueline Mulryne
Profession:Arnold & Porter

As we approach one year to go before the application of Regulations (EU) 745/2017 (Medical Devices) and 746/2017 (In Vitro Diagnostic Medical Devices) (applicable in May 2020 and May 2022, respectively), the European Commission has updated its website to collate all of its guidance on the legislation. This includes a recently published series of nine non-binding practical reference guides, which is now available in a new section of the website entitled "Spread the word" - part of the Commission's campaign to "inform as many stakeholders as possible about their roles and responsibilities under the new Regulations". In particular, they consist of:

"Infographic": An at-a-glance guide, summarising the purpose and key features of the new Regulations, as well as their practical implications. This provides a high-level overview of the new legislation and may be helpful as a training tool to introduce the changes to staff (e.g., it could be easily adapted for use in a training presentation). "Transition timelines": A diagram setting out the periods of application of the current legislation (Directives 93/42/EC (Medical Devices) and 98/79/EC (In Vitro Diagnostic Medical Devices)), the new Regulations, and the transition periods between the two. Again, this is a visual aid, which could be adapted for training purposes, or kept as a quick-reference guide. "Factsheets": High level guidance documents, aimed at each of the following stakeholders, summarising what has changed in the legislation, the implications of these changes for their practices, and when the new obligations will apply: Regulatory / competent authorities in non-EU/EEA member states Authorised representatives, importers and distributors of medical devices and in vitro diagnostic medical devices Manufacturers of...

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