EU - Draft Commission Implementing Regulation Amending Implementing Regulation (EU) 2021/2226 as Regards the Medical Devices for which the Instructions for Use May Be Provided in Electronic Form

Business description

European Commission announces draft Commission Implementing Regulation amending Implementing Regulation (EU) 2021/2226.

This draft Commission Implementing Regulation expands the scope of the possibility to provi​​de electronic instructions for use to all devices intended for exclusive use by healthcare professionals in accordance with Annex I, Chapter III, point 23.1(f), to Regulation (EU) 2017/745. It also requires provision in EUDAMED of the URL to the electronic instructions for use.




Source: G/TBT/N/EU/1113
Countries:
01 European Union
Product categories:
05 Medical Devices
Technical aspects:
Safety
Business fields:
P.05 Medical
Regions:
Europe

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