Person Responsible for Regulatory Compliance

MDR 2017/745 requires that all manufacturers have a PRRC at available at all times. There are clearly defined requirements to the education and regulatory/quality assurance experience of the PRRC and to the responsibility.

The PRRC is responsible for:

(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.

For larger manufacturers this person has to be an employee. For smaller manufacturers (less than 50 employees and less than 10 mill in annual turnover) and authorized representatives it is possible to outsource the position to an external party.

Quality-Audit is able to support your organization with a PRRC.

Contact us if you are in need of a PRRC.

Link to the MDCG position paper on the PRRC role: