For contacting the person responsible for regulatory compliance (PRRC), please use the following contact form. The PRRC covers all issues from article 15, paragraph 3 of the MDR 2017/745.
Summary of article 15, paragraph 3 of the MDR 2017/745:
The person responsible for regulatory compliance shall at least be responsible for ensuring that:
- (a) the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released;
- (b) the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date;
- (c) the post-market surveillance obligations are complied with in accordance with Article 10(10);
- (d) the reporting obligations referred to in Articles 87 to 91 are fulfilled;
- (e) in the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued.