PRRC: qualification and location

MDR and IVDR require manufacturers of medical devices or IVD devices, whose products are on the market of the European Union, to have at their disposal a Person Responsible for Regulatory Compliance (PRRC), an expert who possesses the requisite expertise in the field of medical devices.

But what exactly does "at their disposal" mean? And what is this "requisite expertise"? Little is said about this in MDR and IVDR.

The MDR and IVDR contain general PRRC requirements, but if you need more details on PRRC expertise and localization, you may find helpful the guidance MDCG 2019-7¹. Or you can just read this article.

PRRC within or outside your company?

Both MDR and IVDR state that medical device or IVD manufacturers shall have available within their organization at least one Person Responsible for Regulatory Compliance. The PRRC shall be an employee of the organization.

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However, micro or small enterprises may subcontract the responsibilities of a Person Responsible for Regulatory Compliance to a third party, so long as the qualification criteria are met, and the manufacturer can demonstrate and document how they meet their legal obligations.

Therefore, if your company employs fewer than 50 persons and its annual turnover and/or annual balance sheet total does not exceed 10 million EUR, the PRRC may be part of an external organization, with which the manufacturer has established a contract laying down provisions to ensure the permanent and continuous availability of that party.

PRRC of a group, holding, parent companies and subsidiaries (daughter companies)

In the context of Article 15 of MDR or Article 15 of IVDR, the obligation for having available within the organization at least one PRRC refers to the individual legal manufacturer. This means that organizations with more than one legal manufacturer under the parent company would need to ensure that each legal manufacturer has its own PRRC.

Therefore, if a manufacturer brings its products to the market through several legal manufacturers, it will not be enough to use a single PRRC operating in the parent company. Each individual legal manufacturer under the parent company is required to have its own PRRC.

However, if subsidiaries and daughter companies act as distributors or importers in the EU, they do not need a PRRC because distributors and importers are not required to have one.

Can the PRRC be located outside the EU?

With regard to the geographic location of the PRRC, a manufacturer may wonder where exactly his Person Responsible for Regulatory Compliance should be located. Can PRRC be anywhere?

First of all, it is important that a close linkage, of a permanent and continuous nature, shall be established between the PRRC and the manufacturing activities. For this reason, for non-EU medical device companies, it should be assumed that the PRRC must also be located outside the European Union. While medical device companies located in the EU shall have European PRRC.

This applies in particular to micro or small enterprises that outsource the function of PRRC to third parties. The same rule applies here: For micro or small enterprises located in the EU, it should be assumed that their PRRC must also be located in the EU and vice versa.

PRRC requisite expertise

European Medical Device and In Vitro Medical Device Regulations give manufacturers two alternatives in terms of PRRC's qualifications. MDR and IVDR, state that requisite expertise of the PRRC shall be 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 recognized 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;
• four years of professional experience in regulatory affairs or in quality management systems relating to medical devices.

Obviously, PRRC can't be just anyone. But what about PRRC's credentials from outside the EU?

MDCG 2019-7 gives us some clarification on this issue. For the purpose of fulfilling the requirement laid down in Article 15 (1), any qualification acquired outside the EU, including any university diplomas or certificates, should have been recognized by an EU Member State as equivalent to the EU corresponding qualification.

Another important question is what kind of regulatory experience should the PRRC have? And here again the MDCG guidance is helpful. It says: PRRC's professional experience in regulatory affairs or in quality management systems relating to medical devices should be related to the EU requirements in the field.