According to the presentation answers for the following questions can be given:
- Q: How many Notified Bodies are applying for the new regulation?
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- 28 applications in total were received by SANTE F
- 21 for the MDR
- 7 for the IVDR
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Q: Is it assured that all product codes as published under the C(2017) 7779 are covered?
(for details on the C(2017) 7779 see this post) -
- Yes, for the MDR all scopes are covered
- Yes, for the IVDR all Scopes are covered
- Q: When will the joint assessments of the Notified Bodies be performed?
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- 3 in April 2018 (all MDR)
- 4 in June 2018 (all MDR)
- 2 in July 2018 (all IVDR)
- 3 in September 2018 (2 MDR + 1 IVDR)
- 1 in October 2018 (MDR)
- 3 in November 2018 (1 IVDR + 2 MDR)
- For another 3 Notified Bodies the scheduling is ongoing.
This presentation still leaves some open questions but it sheds some lights on the current situation.