Services
- CertificationWhatever the size of your company, wherever you are based, and whatever the category of your medical devices, we make it our mission to support you throughout your certification process.
- TrainingThe GMED North America Training Center delivers to you its expertise to enhance and develop your skills.
  - Training Catalog
  - Request a Training
- Focus on Medical DevicesTechnical and regulatory information in key medical device fields.
Company
- CompanyPresent in both Europe and North America, GMED’s level of excellence and standards have made it an internationally recognized name in the field of medical device certification.
Knowledge Center
Events

Monday, May 3rd

News

Publication of a new revision (rev. 4) of the MDCG 2018-1 Guidance on basic UDI-DI and changes related to UDI-DI

In the MDCG 2018-1 Rev. 4 Guidance, the definition of the basic UDI-DI has been revised by deleting the concept of group.

In addition, in the section related to the changes on the UDI-DI, clarification has been added regarding the maximum number of reuses of the medical device (if applicable) that the manufacturer shall enter in the UDI database according to Annex VI, Part B, 17 of Regulation (EU) 2017/745.

DOWNLOAD GUIDANCE MDCG 2018-1 Rev.4

Publication of a new revision (rev. 4) of the MDCG 2018-1 Guidance on basic UDI-DI and changes related to UDI-DI

Content

share

Related Posts

Events