| MDCG 2019-2 |
Guidance on application of UDI rules to device-part of products referred to in article 1(8), 1(9) and 1(10) of Regulation 745/2017 |
February 2019 |
| MDCG 2019-1 |
MDCG guiding principles for issuing entities rules on basic UDI-DI |
January 2019 |
| MDCG 2018-7 |
Provisional considerations regarding language issues associated with the UDI database |
October 2018 |
| MDCG 2018-6 |
Clarifications of UDI related responsibilities in relation to article 16 |
October 2018 |
| MDCG 2018-5 |
UDI assignment to medical device software |
October 2018 |
| MDCG 2018-4 |
Definitions/descriptions and formats of the UDI core elements for systems or procedure packs |
October 2018 |
| MDCG 2018-3 |
Guidance on UDI for systems and procedure packs |
October 2018 |
| MDCG 2018-2 |
Future EU medical device nomenclature – Description of requirements |
March 2018 |
| MDCG 2018-1 v2 |
Guidance on basic UDI-DI and changes to UDI-DI |
February 2019 |
| 2019-5 |
Registration of legacy devices in EUDAMED |
April 2019 |
| 2019-4 |
Timelines for registration of device data elements in EUDAMED |
April 2019 |
