News

October 2021:

Publication of MDCG 2021-26 Q&A on repackaging & relabelling activities under Article 16.
Publication of MDCG 2021-25 Application of MDR requirements to ‘legacy devices’ and devices placed on the market prior to 26 May 2021.
Publication of MDCG 2021-24 Guidance on classification of medical devices.
The EUDAMED UDI/Devices and NBs & Certificates modules are now open for economic operators and notified bodies.

August 2021:

Publication of MDCG 2021-23 Guidance for notified bodies, distributors and importers on certification activities in accordance with Article 16(4).

July 2021:

Publication of MDCG 2021-20 Instructions for generating CIV-ID for MDR Clinical Investigations.
Publication of MDCG 2021-19 Integration of the UDI within an organisation’s quality management system.
Publication of MDCG 2021-13 Rev 1 Questions and answers on obligations and related rules for the registration in EUDAMED of actors other than manufacturers, authorised representatives and importers.
Publication of the first opinion of the scientific panels in the fields of medical devices

June 2021:

Publication of the first opinion of the scientific panels in the fields of medical devices
Publication of MDCG 2021-13 Questions and answers on obligations and related rules for the registration in EUDAMED of actors other than manufacturers, authorised representatives and importers
Publication of infographic European Medical Device Nomenclature (EMDN) – Questions and Answers
Publication of MDCG 2021-12 FAQ on the European Medical Device Nomenclature (EMDN)
Publication of MDCG 2021-11 Guidance on Implant Card “Device types”
Publication of a Joint implementation and preparedness plan for the IVDR