MDR - annex XII - chapter II

Original text

Expert opinion

Minimum content of the certificates

1. name, address and identification number of the notified body;

2. name and address of the manufacturer and, if applicable, of the authorised representative;

3. unique number identifying the certificate;

4. if already issued, the SRN of the manufacturer referred to in to Article 31(2);

5. date of issue;

6. date of expiry;

7. data needed for the unambiguous identification of the device or devices where applicable as specified in Section 4 of Part I;

8. if applicable, reference to any previous certificate as specified in Section 8 of Chapter I;

9. reference to this Regulation and the relevant Annex in accordance with which the conformity assessment has been carried out;

10. examinations and tests performed, e.g. reference to relevant CS, harmonised standards, test reports and audit report(s);

11. if applicable, reference to the relevant parts of the technical documentation or other certificates required for the placing on the market of the device or devices covered;

12. if applicable, information about the surveillance by the notified body;

13. conclusions of the notified body’s conformity assessment with regard to the relevant Annex;

14. conditions for or limitations to the validity of the certificate;

15. legally binding signature of the notified body in accordance with the applicable national law.

Certificates issued by NB

The certificates issued by a Notfied Body (NB) has to hold at least the information listed in the Annex XII.
As the certification holder, you are adviced to check all the data for correctness and inform immediately the NB in cases of errors. Please be further adviced that all applicable locations of the manufacutere and/or EC REP should be listed on the certificate.


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