2019-9 Guide for Summary of safety and clinical performance
SSCP ...

Size	122.24 KB
Downloaded	4 times
Last Updated	1 October 2019
Download

2019-7 Person Responsible for Regulatory Compliance (PRRC)
...

Size	80.57 KB
Downloaded	6 times
Last Updated	8 July 2019
Download

2019-3 Interpretation of Article 54(2)b
...

Size	488.94 KB
Downloaded	6 times
Last Updated	9 July 2019
Download

2019-2 UDI rules to device-part of products referred to in Regulation 745/2017
...

Size	388.39 KB
Downloaded	5 times
Last Updated	15 July 2019
Download

2019-1 Issuing entities rules on Basic UDI-DI
...

Size	211.08 KB
Downloaded	5 times
Last Updated	15 July 2019
Download

2018-7 Provisional considerations regarding language issues associated with the UDI database
MDCG ...

Size	332.55 KB
Downloaded	21 times
Last Updated	8 July 2019
Download

2018-6 Clarifications of UDI related responsibilities in relation to Article 16 (MDR)
...

Size	0.00 KB
Downloaded	21 times
Last Updated	18 October 2018
Download

2018-5 UDI Assignment to Medical Device Software
...

Size	343.45 KB
Downloaded	19 times
Last Updated	18 October 2018
Download

2018-4 UDI core elements systems or procedure packs
Definitions/Descriptions and formats of the UDI core elements for systems or procedure packs ...

Size	299.19 KB
Downloaded	16 times
Last Updated	18 October 2018
Download

2018-3 Guidance on UDI for systems and procedure packs
MDCG ...

Size	0.00 KB
Downloaded	18 times
Last Updated	18 October 2018
Download