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  • 10 July 2019

    About SRN request by Notified Bodies

    2019-07-10 _ About SRN request by Notified Bodies

  • 1 July 2019

    Guidance about PPRC

    Guidance on Article 15 - MDR_IVDR PPRC Person Responsible for Regulatory Compliance

  • 1 April 2019

    Brexit _ UKCA marking April 01, 2019 Update

    Using the UKCA marking if the UK leaves the EU without a deal.

    GOV-UK - April 01, 2019 publishing

  • 19 March 2019

    BREXIT ISSUES - 2019-03-19 MHRA last update _ vs EU Com release dated Feb 01st

    MHRA March 19th 2019 Update about Brexit Issues confronted to EU Com last release about (how to manage) Brexit issues.

    Complementary points of views, even if some zones of confusion still exist due to the general historical and even more to the current context, as you may guess.

  • 7 March 2019

    2019-03-04 EUDAMED code chosen is Italian CDN

    2019-03-06 - European Commission: CND replaces GMDN for DM nomenclature

    The European Commission published on March 4, 2019, a document on the nomenclature of medical devices.

    _ The surprise is that the GMDN ("Global Medical Device Nomenclature") was not finally selected by the European Commission:

    - it is the CND ("Classificazione Nazionale dei Deviceivi medici"), a nomenclature established by the Italy, which will be used for EUDAMED.


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