MEDICAL DEVICES

IN VITRO DIAGNOSTIC MEDICAL DEVICES

Chapter II: 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. egally binding signature of the notified body in accordance with the applicable national law.