| Date | Guidance No | About the Guidance |
|---|---|---|
| 25 Sep 2024 | MDCG 2021-4 rev.1 | Application of transitional provisions for certification of class D in vitro diagnostic medical devices under Reg (EU) 2017/746 – September 2024 This essentially a Q&A document. The revisions are detailed on page 2 of the document. |
| 8 Jul 2024 | MDCG 2020-16 Rev.3 | Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746 – July 2024 This guidance, relating to the application of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) addresses the classification of in vitro diagnostic medical devices (IVDs) and provides clarifications on the classification rules as set out under Annex VIII. This classification guidance also applies to diagnostic or information society services performed on EU patients or devices put in to service through distance sales. The revisions are detailed on page ii of the document. |
| 2 Jul 2024 | MDCG 2021-5 Rev.1 | Guidance on standardisation for medical devices – July 2024 This document aims to provide guidance on different aspects related to standards in the medical devices sector in support of the requirements laid down in the applicable EU legislation, taking into account its specificities. There are many changes in this revision and they are provided on page 2 of the updated guidance. |
Pharmavibes
medicines-medical devices-regulatory affairs