Person responsible for regulatory compliance - PRRC
Published:
Changes
MDR and IVDR require a person to be responsible for complying with the regulations, a PRRC. This will strengthen the regulatory competence of manufacturers and authorised representatives. See Article 15 of the MDR and IVDR.
Manufacturers and authorised representatives must have at least one PRRC in their organisation, who has the necessary expertise in the field of medical devices.
The necessary expertise shall be demonstrated with one of the following:
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Qualification certificate awarded after completing a degree in law, medicine, pharmacy, engineering or another relevant scientific discipline, and at least one year of professional experience in regulatory affairs or quality management systems relating to medical devices.
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Four years of professional experience in regulatory affairs or quality management systems relating to medical devices.
PRRC for manufacturers of custom-made devices must demonstrate the necessary expertise by documenting that they have at least two years' professional experience within relevant field of manufacturing (including technology). In addition the knowledgde and ecperience of the PRRC must cover regulatory aspects of the production of cutom-made devices, such as preparation and maintenance of the manufacturer's quality management system.
Manufacturers with less than 50 employees are not required to have a PRRC within their organisation, but must have such a person available at all times.
The PRRC shall be at least be responsible for ensuring that:
- 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
- the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date
- the post-market surveillance obligations are complied with in accordance with Article 10 (10)
- the reporting obligations referred to in Articles 87 to 91 are fulfilled
- in the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued.
For further information, see the guide MDCG 2019-7 Guidance on Article 15 of the Medical Device Regulation (MDR) and in vitro Diagnostic Device Regulation (IVDR) regarding a person responsible for regulatory compliance (PRRC).
For further information, see the guide MDCG 2019-7 rev 1 Guidance on Article 15 of the Medical Device Regulation (MDR) and in vitro Diagnostic Device Regulation (IVDR) regarding a person responsible for regulatory compliance (PRRC).