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 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.
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
