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Person responsible for regulatory compliance

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.

Contact Form


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