Today, at a conference in Brussels, the European Commission shared important points and dates regarding the MDR implementation and preparedness of the regulatory framework, and main actors for May 2020.
Notified Bodies (NBs)
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As of February 2019, 33 NBs applied under the MDR and 9 NBs under the IVDR; so far, there were 25 Joint Assessments performed and 3 are scheduled;
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New designations of NBs can soon be expected and significant number of newly designated NBs is estimated by end of 2019;
MDCG Working Groups will be operational from 1st of March 2019 (List of observers should be shortly published); So far, MDCG met eight times, you can here find a schedule of MDCG and its subgroups meetings;
Functional specifications for EUDAMED should be released next week;
Designation of UDI issuing entities is expected by May 2019;
By mid-2019:
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Guidance on vigilance (April/May)
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Guidance on software
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Guidance on classification
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Guidance on clinical evidence
Under preparation:
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Guidance for substance-based devices
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Common Specifications on Annex XVI
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Common Specifications on reprocessing (as well as Implementing Act)
It was indicated by other speakers that the first NB designated under the IVDR is forecasted for July 2019!
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