(a) A diploma, certificate, or other official qualification awarded upon completion of a university degree or education recognized as equivalent by the relevant Member State in Law, Medicine, Dentistry, Pharmacy, Engineering, or another related scientific discipline, along with a minimum of one year of professional experience in regulatory affairs or quality management systems related to Medical Devices;
(b) Four years of professional experience in regulatory affairs related to Medical Devices or in Quality Management Systems.
Without prejudice to national provisions concerning professional qualifications, manufacturers of custom-made devices may demonstrate the required expertise referenced in the first subparagraph through a minimum of two years of professional experience in the relevant manufacturing field.
MDCG 2019-7 Guide on the ‘Person Responsible for Regulatory Compliance’ (PRRC) under the Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR) Article 15
Under Commission Recommendation 2003/361/EC, micro and small enterprises are not required to have a person responsible for regulatory compliance within their organization; however, such businesses must permanently and continuously obtain services from such a person.
Manufacturers: Businesses employing at least 50 people and with an annual turnover and/or annual balance sheet total exceeding 10 million euros.
Micro and small manufacturers: Businesses employing fewer than 50 people and with an annual turnover and/or annual balance sheet total not exceeding 10 million euros.
Authorized Representatives must also have a Person Responsible for Regulatory Compliance (PRRC), and this requirement must be defined in the Authorized Representative Agreement.
Responsibilities of the Person Responsible for Regulatory Compliance;
- Before a device is placed on the market, ensuring the conformity of the devices according to the Quality Management System under which they are manufactured.
- Preparing and keeping the Technical Documentation and the EU Declaration of Conformity up to date.
- Fulfilling post-market surveillance obligations.
- Ensuring that the manufacturer complies with critical reporting obligations.
- In the case of devices intended for research purposes, preparing the declaration referred to in Section 4.1 of Annex XV.