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EU IVD Risk Determination of sample collection

  • Thread starter Murielle Meunier
  • Start date
M

Murielle Meunier

#1
In the EU IVD Regulation 2017/746, Chapter VI Article 58 paragraph 1 calls out the following:

Any performance study: (a) in which surgically invasive sample-taking is done only for the purpose of the performance study;
(b) that is an interventional clinical performance study as defined in point (46) of Article 2; or
(c) where the conduct of the study involves additional invasive procedures or other risks for the subjects of the studies, shall, in addition to meeting the requirements set out in Article 57 and Annex XIII, be designed, authorised, conducted, recorded and reported in accordance with this Article and Articles 59 to 77 and Annex XIV.

If your study complies with a, b or c you need to apply for your study within the member states it is executed.

Does article (c) also imply low risk invasive procedures such as vaginal/ saliva swabs, blood withdrawals, finger prick... ? Is there any guidance document available on this paragraph?

Thank you,
Murielle Meunier
 
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