European Medicines Agency updated the page Medical devices, on June 29, 2021, by adding a questionnaire with respect to the implementation of the Medical Devices and In Vitro Diagnostic Medical Devices Regulations ((EU) 2017/745 and (EU) 2017/746).
The PDF document has been uploaded to provide explicit guidance to Applicants, Marketing Authorisations Holders (MAH) and notified bodies (NB). The question and answers in this document are mainly related to regulatory framework and submissions of medical devices under the new Regulation (EU) 2017/745, and Regulation (EU) 2017/746. It covers questions in relation to medical devices that form an integral product with a medicinal product, medicinal products that include a medical device in the secondary packaging of the marketed medicinal product (co-packaged), and consultation procedure for ancillary medicinal substances that are integral part of medical devices.
This document will be updated regularly and will be marked by “New” or “Rev.” with the relevant date upon publication. As of now, the document does not contain any questions regarding transparency.