MDR and IVDR require that a person be responsible for complying with the regulations (PRRC, person responsible for regulatory compliance). 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:
- 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.
- Four years of professional experience in regulatory affairs or quality management systems relating to medical devices.
Manufacturers of custom-made devices may demonstrate the necessary expertise by documenting that they have at least two years' professional experience in a relevant manufacturing area.
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).