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
G/TBT/N/EU/1113
Eingangsdatum:
2025 March 06
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Frist für Kommentare:
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Beschreibung
This draft Commission Implementing Regulation expands the scope of the possibility to provide 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.
Disclaimer:
Please note that the information published is not necessarily comprehensive. In particular, documents of notifications dated before 1 January 2014, and comments and answers received or sent on TBT notifications before 1 January 2018 are not publicly available due to data protection requirements. Some comments and answers received or sent after 1 January 2018 may be unavailable also for data protection reasons.