Regulation (EU) 2017/745 of the European Parliament and of the CouncilShow full title

Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (Text with EEA relevance)

CHAPTER IIU.K. 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.