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MDCG 2018-4 : Annex: UDI database Definitions/Descriptions and formats of the UDI core elements for systems or procedure packs – October 2018

19 Nov 2020 | MDCG

Theme UDI – Systems and procedure pack Target audience Persons referred to in Article 22 (Systems and procedure pack producer) Products concerned MD Regulatory references MDR (EU) 2017/745 Article 29(2) Annex VI Part B Documents mentioned   This guide provides...

MDCG 2018-3 Rev.1 : Guidance on UDI for systems and procedure packs – June 2018

19 Nov 2020 | MDCG

Theme UDI – Systems and procedure pack Target audience Persons referred to in Article 22 (Systems and procedure pack producer) Products concerned MD Regulatory references MDR (EU) 2017/745 Article 22 Article 29(2) Annex VI Part C points 3.7 and 6.3.1 Documents...

MDCG 2018-2 : Future EU medical device nomenclature – Description of requirements – Mars 2018

19 Nov 2020 | MDCG

  Theme European MD nomenclature (EMDN) Target audience All actors Products concerned MD, IVD Regulatory references MDR (EU) 2017/745 Article 26 IVDR (EU) 2017/746 Article 23 Documents mentioned   The purpose of this guide is to clarify the criteria and...

MDCG 2018-1 Rev. 4 : Guidance on basic UDI-DI and changes to UDI-DI – March 2020

19 Nov 2020 | MDCG

  Theme Basic UDI and UDI-DI Target audience Manufacturers Products concerned MD, IVD Regulatory references MDR (EU) 2017/745 Chapter III Annex VI IVDR (EU) 2017/746 Chapter III Annex VI Documents mentioned UDIWG 2018-1 European Commission : Q/A about UDI  ...

MD and IVD Regulations and standards: where are we now?

13 Nov 2020 | All the News, Risk management

On 29 October 2020, the European Commission published a new version of the Draft standardisation request as regards medical devices (MD) in support of Regulation (EU) 2017/745 and in vitro diagnostic medical devices (IVD) in support of Regulation (EU) 2017/746. Does...
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