5 new guidance documents concerning the implementation of the UDI in Europe published by MDCG
The Medical device coordination group (MDCG) publishes 4 guidance documents on the implementation of the Unique device identification (UDI) under the new European regulatory framework.
Todays publication list includes:
- MDCG 2018-3
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- Guidance on UDI for systems and procedure packs
- MDCG 2018 -04 Annex
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- UDI database Definitions/Descriptions and formats of the UDI core elements for systems or procedure packs
- MDCG 2018 -05
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- UDI Assignment to Medical Device Software
- MDCG 2018 -06
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- Clarifications of UDI related responsibilities in relation to Article 16 of the Medical Device Regulation 2017/745 and the In-Vitro Diagnostic Medical Devices Regulation 2017/746
- MDCG 2018 -07
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- Provisional considerations regarding the language issues associated with the UDI database (Annex VI, Part A Section 2 and Part B of the Medical Devices Regulation 2017/745 and the In-Vitro Diagnostic Medical Device Regulation 2017/745