Person Responsible for Regulatory Compliance (PRRC)
Article 15 of both the in vitro diagnostic medical device regulation (2017/746) and the medical device regulation (2017/745) describe the new obligation that manufacturers and authorised representatives must meet such that they must have at least one Person Responsible for Regulatory Compliance (PRRC) “available within their organisation”. Manufacturers and authorised representatives must demonstrate that the PRRC have the requirements detailed in the Article.
Micro and small enterprises will not be required to have a PRRC within their organisation, however they must have such a person permanently and continuously at their disposal. The definition of micro and small enterprises is given below, in accordance with Commission Recommendation 2003/361/EC:
- Micro: Employees < 10, Annual Turnover / Annual Balance Sheet Total < EUR 2 million
- Small: Employees < 50, Annual Turnover / Annual Balance Sheet Total < EUR 10 million
The PRRC shall ensure that:
- Device conformity is adequately checked in accordance with the manufacturer’s quality management system, prior to release.
- Technical documentation and EU Declaration of Conformity are drawn up and kept up-to-date.
- Post-market obligations are met.
- Reporting obligations are met.
- Compliance for investigational devices or devices for performance studies with respect to Section 4.1 of Annex XV (MDR) and XIV (IVDR).
Multiple PRRCs may be appointed, and these can further delegate work as long as each respective area is covered and that all PRRCs and their responsibilities are recorded.
From the current interpretation of Article 15 of these Regulations, the PRRC shall not be individually held liable with matters related to the fulfilment of their duties. Whether this is correct or not will require further clarification.
Manufacturers and authorised representatives will need to submit the name, address, and contact details of the person, or persons responsible for regulatory compliance upon registration. Furthermore, this will need to be kept up to date if any changes are made.
We expect that further guidance will be released related to this subject.