Spotlight

What is a PRRC and what are their Responsibilities?

PRRC

What is a PRRC? #

PRRC is the abbreviated form of “Person Responsible for Regulatory Compliance” and is one of the requirements for compliance with the EU Medical Device Regulation (MDR) and IVD Regulation (IVDR). The requirement itself stems from Article 15 of both these EU Regulations; the article itself lays out the criteria of who may be appointed as a PRRC and what their obligations will be.

Manufacturers placing their products on the EU market and their EU Authorised Representatives (AR / EC-REP) are required to appoint a PRRC. As the term suggests, the PRRC is the “go-to” person (or persons) who should be knowledgeable about EU regulatory obligations. The remainder of this article shall focus on PRRC requirements specifically for medical device manufacturers, although it shall also apply for IVDs.

Additional guidance on Article 15 is provided in MDCG 2019-7.

Who can be a PRRC? #

In order to be appointed a PRRC, that person must have the “requisite expertise” within the field of medical devices which must be demonstrated by either of the following:

  • (a) 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;
  • (b) four years of professional experience in regulatory affairs or in quality management systems relating to medical devices.
EU MDR / EU IVDR Article 15(1)

A person choosing to demonstrate their requisite expertise through point (a) must ensure that the diploma or certificate is recognised as equivalent by the Member State concerned. This means that a qualification obtained from a non-EU institution must be verified as equivalent to that in the EU Member State. This can be a bit tricky to prove and in many cases will require additional dialogue with a relevant national authority within that Member State. The following link should be of assistance: Recognition of academic diplomas.

Although it is not very clear in the Regulation, “professional experience in regulatory affairs or in quality management systems relating to medical devices” is widely understood as experience relevant to the regulation of medical devices in the EU. This may thus disqualify persons with experience solely in the legislative framework outside of the EU, however, interpretations on this may vary.

For manufacturers of custom-made medical devices (CMDs), the organisation can demonstrate requisite experience in the field of medical devices by having at least two years of professional experience within a relevant field of manufacturing.

It is also possible for a manufacturer to have more than one PRRC who are jointly responsible for regulatory compliance. In such a case, their respective areas of responsibility shall be recorded. In all cases, we recommend that the manufacturer issues a ‘Letter of Appointment’ which indicates the person chosen as the PRRC, signed by both parties. Either as part of this letter, or in a separate document such as a Job Description, it would be advantageous to clearly indicate their responsibilities as well as demonstratable evidence of the requisite expertise.

Is it mandatory to have a PRRC? #

The simple answer is, yes; Article 15 is very clear in that the legal manufacturer requires a PRRC to be available within their organisation. This means that the PRRC must be an employee of that organisation.

However, it does make an exception with respect to the “within their organisation” requirement for companies which qualify as a “micro” or “small” enterprise, as defined in Commission Recommendation 2003/361/EC:

  • 1. The category of micro, small and medium-sized enterprises (SMEs) is made up of enterprises which employ fewer than 250 persons and which have an annual turnover not exceeding EUR 50 million, and/or an annual balance sheet total not exceeding EUR 43 million.
  • 2. Within the SME category, a small enterprise is defined as an enterprise which employs fewer than 50 persons and whose annual turnover and/or annual balance sheet total does not exceed EUR 10 million.
  • 3. Within the SME category, a microenterprise is defined as an enterprise which employs fewer than 10 persons and whose annual turnover and/or annual balance sheet total does not exceed EUR 2 million.
Commission Recommendation 2003/361/EC Article 2.

This exception allows micro and small enterprises to subcontract their PRRC to a third party who must be permanently and continuously at their disposal. The latter phrase is important as it sets an expectation for the location of the PRRC.

The PRRC location is also brought up in MDCG 2019-7 which stresses the importance of a close, permanent and continuous relationship to exist between the PRRC and the manufacturing activities. Therefore, it would be assumed that a manufacturer based outside of the EU should have a PRRC based outside of the EU, and vice versa. However, it would be safe to say that the PRRC should be at least based within the same country or within a reasonable distance of the manufacturer. This was something expected by Notified Bodies during their assessments. At the very least, a robust justification as to how the PRRC is continuously and permanently available should be provided.

It will certainly be advantageous for the manufacturer to have the PRRC as part of their own team and so we would encourage that relevant employees are provided with the appropriate training to fill the role.

PRRC Responsibilities #

The Person Responsible for Regulatory Compliance shall be in charge of ensuring that:

  1. Device conformity has been checked in accordance with the QMS, prior to product release.
  2. EU technical documentation and EU declaration of conformity have been drawn up and are kept up to date.
  3. Post-market surveillance (PMS) obligations are complied with.
  4. Reporting and vigilance obligations are fulfilled.
  5. Annex XV statement [investigational devices] is issued.

It will be key to understand that the PRRC is responsible for ensuring that the above are carried out, they are not necessarily required to perform the tasks themselves. The PRRC should definitely be aware and knowledgeable of how these activities should be carried out and must have demonstratable knowledge of issues such as PMS, vigilance, and technical documentation requirements.

The PRRC will therefore require a certain level of access to the manufacturer’s documentation and quality records. Transparency with the PRRC will be key in order for them to identify any obligations which may not have been met.

Other note-worthy points. #

Article 15(4) states that the PRRC should be able to exercise their duties without suffering disadvantage within the organisation. This means that the PRRC should not, in any way, be penalised if they have identified certain shortfalls in the manufacturer’s compliance with the regulations. In a way, the PRRC is backed up by the law in order to be able to fulfil their responsibilities without fear of any repercussions.

If you are opting to subcontract a PRRC, ensure that you have an appropriate contractual agreement in place which clearly indicates their responsibilities within the organisation as a PRRC. It should also clearly show the permanent and continuous nature of the relationship. The contract should not have a time or duration limit but should take into account the normal office hours during which the PRRC may be reached.

Although not stipulated within the Regulations, the PRRC shall be indicated within Eudamed for that medical device manufacturer and authorised representative as part of the actor registration process. The Eudamed actor profile must be amended in the event of an update to the PRRC details.

It should be noted that you will not be able to outsource your PRRC to the PRRC of your authorised representative, as this would be a potential conflict of interest.

Finally, we recommend that the subcontracted PRRC acquire Professional Indemnity insurance in order to protect them from any potential legal claims.

How can we help? #

Specculo does not currently provide the service as a PRRC. However, we offer a specialised PRRC training session to those persons wishing to take on the role of PRRC.

Furthermore, through our General Consulting services, we can provide you with guidance in developing your agreement or assessing your system to ensure compliance with the Regulations.