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:

(3) 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 Person Responsible for Regulatory Compliance

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Was the product used on a patient?*

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