Person Responsible for Regulatory Compliance2024-12-04T02:00:52+03:00

Manufacturers shall have at least one person within their organization who is responsible for regulatory compliance and possesses the necessary expertise in the field of Medical Devices. The required expertise is demonstrated through any of the following qualifications:

(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.
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