In the most recently endorsed document, the MDCG addressed the issue of inconsistency between Article 123(3)(d) and 123(3)(e) of the MDR. These provisions foresee certain derogation from the general entry into force and date of application of the Regulation – 26 May 2020. 123(3)(d) envisages applicability of the Regulation from the general date of application or with a 6 months ”delay” if EUDAMED would not be functional by May 2020 for the whole Article 29 (Registration of devices); while 123 (3)(e) gives a ”grace period” of 18 months solely to 29 (4) (Part A of Annex VI related to device data to be inserted in EUDAMED).
The MDCG stated while taking into account:
-
the declared will of the co-legislator to grant an 18-month additional transitional period for device registration and registration of certificates,
-
the logical correspondence and complementary character of device data elements in Part A (Section 2) and Part B of Annex VI,
-
the need to ensure that information on devices in EUDAMED is not displayed to public in a partial or misleading nature,
the obligation for registration in EUDAMED of device data elements listed in both part A, Section 2, and Part B of Annex VI, shall be applicable as from the timelines indicated in Article 123(3)(e) (meaning from 18 months after the general application date or, if EUDAMED is not fully functional on time, from 24 months after the date of publication of the notice referred to in Article 34(3)).
Subscribe to MDlaw and stay informed on any new documents produced by the MDCG.
Leave a Reply