IVDR Article 52 — Electronic system on notified bodies and on certificates of conformity

Article 52

Electronic system on notified bodies and on certificates of conformity

For the purposes of this Regulation, the following information shall be collated and processed pursuant to Article 57 of Regulation (EU) 2017/745 in the electronic system set up in accordance with that Article:

(a)

the list of subsidiaries referred to in Article 33(2);

(b)

the list of experts referred to in Article 36(2);

(c)

the information relating to the notification referred to in Article 38(10) and the amended notifications referred to in Article 42(2);

(d)

the list of notified bodies referred to in Article 39(2);

(e)

the summary of the report referred to in Article 40(12);

(f)

the notifications for conformity assessments and certificates referred to in Article 50(1);

(g)

withdrawal or refusals of applications for the certificates as referred to in Article 49(2) and Section 4.3 of Annex VII;

(h)

the information regarding certificates referred to in Article 51(5);

(i)

the summary of safety and performance referred to in Article 29.

This tool is provided for convenience only and has no legal effect. Only the texts published in the Official Journal of the European Union are authentic. Source: EUR-Lex, CELEX 02017R0746-20250110, © European Union. Reuse is authorised provided the source is acknowledged.

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