PRRC For Medical device Manufacturers

All manufacturers must have a Person responsible for regulatory compliance (PRRC).  It is one of requirements of the European Union’s Medical Device Regulation (MDR) and In-Vitro Diagnostic Medical Device Regulation (IVDR). It intends to ensure companies have a qualified regulatory expert at their disposal. If a company consists of more than one legal manufacturer, each legal manufacturer must appoint its PRRC. Manufacturers are required to confirm that their EU authorised representative has appointed a same person too.

Who can be a PRRC?

Article 15(1) of the MDR and the IVDR calls for a person possessing the requisite expertise in the field of medical devices, which is defined as qualifications that are demonstrated by either:
  • a diploma, certificate or other evidence of formal qualification, awarded on completion of a university degree 
  • or of a course of study recognised as equivalent by the Member State concerned, in law, medicine, pharmacy, engineering or another relevant scientific discipline, and at least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices 
  • or four years of professional experience in regulatory affairs or in quality management systems relating to medical devices.

While formal qualification is easily documented with a diploma or certificate, professional experience in medical device regulatory affairs or in quality management systems (referring to experience gained in the EU) has to be demonstrated as well. Qualification based on professional experience has to be substantiated with documents such as a work contract, organisation chart, training evidence or internal records such as document releases.

In the additional guidance document MDCG 2019-7, the EU Medical Device Coordination Group clarifies how to interpret Article 15. With regard to the required qualifications, the guidance adds that, for the purpose of fulfilling the requirements in Article 15(1), qualifications acquired outside the EU should have been recognised by an EU Member State as equivalent to the corresponding qualification in the EU.

responsibilities of a PRRC under the MDR

Article 15(3) of the EU MDR outlines the requirements and responsibilities of the PRRC. The PRRC of a manufacturer is 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; NOTE: This refers to Vigilance reporting, i.e. serious incident, field safety corrective action, and incident trend reporting).
  • the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued. NOTE: This refers to the statement confirming that the investigational device conforms to the General Safety and Performance Requirements in Annex I of the EU MDR, except those relative to aspects covered by the clinical investigation and that, for these, precautions are taken to protect the subject’s health and safety.

The MDR stipulates that the name and contact details of the appointed person responsible for regulatory compliance have to be entered in the EUDAMED database. The MDR does not stipulate that the PRRC has to perform all tasks and activities in order to ensure compliance with the requirements, but that those are performed under his/her responsibility.

The role of the PRRC has to be included into the quality management system, and the role will be subject to scrutiny during audits.

Who needs a PRRC?

All manufacturer of Medical Devises must have a PRRC.  If a company consists of more than one legal manufacturer, each legal manufacturer must appoint its own PRRC.

  • Companies with fewer than 50 employees and an annual turnover under EUR 10 million (falling within the definition of micro and small enterprises as per Commission Recommendation 2003/361/EC) are allowed to outsource their PRRC to an outside expert, under the conditions that the PRRC fulfils the qualification criteria and is permanently and continuously at their disposal
  • The enterprises which employ at least 50 persons and whose annual turnover and/or annual balance sheet total exceeds EUR 10 million required to have available within their organisation at least one PPRC with proper expertise in the field of medical devices or in vitro medical devices.

OUR price for PRRC services

1500 EUR 
per annum


3000 EUR
per annum

II a, B class MDR Class C,B IVDR

4500 EUR
per annum

III class MDR Class D IVDR

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