지침,참고문헌 | MDCG 2019-4 Timelines for registration of device data elements in EUDAMED

MDCG 2019-4_devices_registration_eudamed_en.pdf (273.8K) [30]

“With regard to timelines for device registration, the text of the MDR presents an inconsistency. On the one hand, Article 123(3)(d) lists the full Article 29 as being applicable from the application dates or, if EUDAMED is not functional on time, six months after the date of publication of the notice referred to in Article 34(3). On the other hand, Article 123(3)(e) grants an additional 18-month transitional period for obligations contained in Article 29(4).
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)).
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