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The Person Responsible for Regulatory Compliance (PRRC) under the MDR and the IVDR (Art. 15/15)

PPRC: Definition & Purpose

The Person Responsible for Regulatory Compliance (PRRC) is, under the MDR and the IVDR, a person responsible for ensuring compliance with the MDR/IVDR requirements regarding the conformity of the devices, the technical documentation, the EU declaration of conformity, the post-market surveillance obligations and the reporting of serious incidents and field safety corrective actions (FSCAs). 

The manufacturer and its authorized representative(s) shall have available within their organisation, permanently and continuously, at least one PPRC at their disposal. 

Note that the PRRC of a manufacturer cannot also be its authorized representative.

MDR/IVDR Requirements about the PRRC

Article 15 MDR and article 15 IVDR mention the requirements for the PRRC. Both articles have almost the same requirements. Minor differences can be highlighted (See Comparison Table below).

Qualifications of the PRRC

The PRRC shall have several requisite expertise in the field of medical devices, demonstrated by either of the following qualifications:

(a) a formal qualification (diploma, certificate, university degree, course of study) in law, medicine, pharmacy, engineering or another relevant scientific discipline. This formal qualification shall be recognised as equivalent by the Member State concerned) AND at least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices; 

Note that for manufacturers of custom-made devices, the PRRC may demonstrate at least two years of professional experience within a relevant field of manufacturing.

OR

(b) four years of professional experience in regulatory affairs or in quality management systems relating to medical devices.

Responsibilities of the PRRC

The PRRC shall at least be responsible for ensuring that:

(a) the conformity of the devices is appropriately checked, in accordance with the quality management system (QMS) under which the devices are manufactured, before a device is released;

(b) the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date;

(c) the post-market surveillance obligations are complied with in accordance with the manufacturer obligations;

(d) the reporting obligations are fulfilled;

(e) in the case of investigational devices, the statement that must be referred is issued.

More than one person can be in charge of these obligations, but their respective areas of responsibility shall be stipulated in writing.

The Independence of the PRRC

Both MDR and IVDR stipulate that the PRRC shall suffer no disadvantage within the manufacturer’s organisation in relation to the proper fulfilment of his or her duties, regardless of whether or not they are employees of the organisation.

For Micro and Small Enterprises

Micro and small enterprises shall not be required to have the PRRC within their organisation but shall have such person permanently and continuously at their disposal.

The definition of micro and small enterprises can be founded in the Commission Recommendation 2003/361/ΕC of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises (OJ L 124, 20.5.2003, p. 36).

About the Authorized Representatives

Similar requirements (qualifications and obligations) must be also fulfilled by the authorized representatives.

About Liability

The potential liability of the PRRC is not explicitly addressed in the current revision of the MDR/IVDR. Therefore, this point is left to the Member States in their implementation of the MDR and IVDR in national law..

A limitation of liability or an exemption can be included in the employment contract of PRRC – This one must be reviewed carefully.

Usually, in cases of ordinary negligence, the PRRC is not personally liable. But in cases of gross negligence, the manufacturer may take recourse against the PRRC.

In the case of gross negligence and intent, such an exclusion is not reasonable or possible. There is also a risk of criminal prosecution.

In essence, infringement of the PRRC responsibilities is subject to competent authority enforcement by means of administrative fines and penalty payments. But it is still unclear whether the enforcement may be directed against the manufacturer and/or the PRRC.

Comparison Table

Differences are in orange.

EU MDR – Regulation (EU) 2017/745
EU IVDR – Regulation (EU) 2017/746

Article 15

Person responsible for regulatory compliance

Article 15

Person responsible for regulatory compliance

1. Manufacturers shall have available within their organisation at least one person responsible for regulatory compliance who possesses the requisite expertise in the field of medical devices. 

The requisite expertise shall be demonstrated by either of the following qualifications:

(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.

Without prejudice to national provisions regarding professional qualifications, manufacturers of custom-made devices may demonstrate the requisite expertise referred to in the first subparagraph by having at least two years of professional experience within a relevant field of manufacturing.

1. Manufacturers shall have available within their organisation at least one person responsible for regulatory compliance who possesses the requisite expertise in the field of in vitro diagnostic medical devices. 

The requisite expertise shall be demonstrated by either of the following qualifications:

(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 in vitro diagnostic medical devices;

(b) four years of professional experience in regulatory affairs or in quality management systems relating to in vitro diagnostic medical devices.

2. Micro and small enterprises within the meaning of Commission Recommendation 2003/361/EC ( 1 ) shall not be required to have the person responsible for regulatory compliance within their organisation but shall have such person permanently and continuously at their disposal.

( 1 ) Commission Recommendation 2003/361/ΕC of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises (OJ L 124, 20.5.2003, p. 36).

2. Micro and small enterprises within the meaning of Commission Recommendation 2003/361/EC ( 1 ) shall not be required to have the person responsible for regulatory compliance within their organisation but shall have such person permanently and continuously at their disposal.

( 1 ) Commission Recommendation of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises (OJ L 124, 20.5.2003, p. 36).

3. The person responsible for regulatory compliance shall at least be responsible for ensuring that:

(a) 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;

(b) the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date;

(c) the post-market surveillance obligations are complied with in accordance with Article 10(10);

(d) the reporting obligations referred to in Articles 87 to 91 are fulfilled;

(e) in the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued.

3. The person responsible for regulatory compliance shall at least be responsible for ensuring that:

(a) 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;

(b) the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date;

(c) the post-market surveillance obligations are complied with in accordance with Article 10(9);

(d) the reporting obligations referred to in Articles 82 to 86 are fulfilled;

(e) in the case of devices for performance studies intended to be used in the context of interventional clinical performance studies or other performance studies involving risks for the subjects, the statement referred to in Section 4.1 of Annex XIV is issued.

4. If a number of persons are jointly responsible for regulatory compliance in accordance with paragraphs 1, 2 and 3, their respective areas of responsibility shall be stipulated in writing.

4. If a number of persons are jointly responsible for regulatory compliance in accordance with paragraphs 1, 2 and 3, their respective areas of responsibility shall be stipulated in writing.

5. The person responsible for regulatory compliance shall suffer no disadvantage within the manufacturer’s organisation in relation to the proper fulfilment of his or her duties, regardless of whether or not they are employees of the organisation.

5. The person responsible for regulatory compliance shall suffer no disadvantage within the manufacturer’s organisation in relation to the proper fulfilment of his or her duties, regardless of whether or not they are employees of the organisation.

6. Authorised representatives shall have permanently and continuously at their disposal at least one person responsible for regulatory compliance who possesses the requisite expertise regarding the regulatory requirements for medical devices in the Union. The requisite expertise shall be demonstrated by either of the following qualifications:

(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.

6. Authorised representatives shall have permanently and continuously at their disposal at least one person responsible for regulatory compliance who possesses the requisite expertise regarding the regulatory requirements for in vitro diagnostic medical devices in the Union. The requisite expertise shall be demonstrated by either of the following qualifications:

(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 in vitro diagnostic medical devices;

(b) four years of professional experience in regulatory affairs or in quality management systems relating to in vitro diagnostic medical devices.

Recommended Reading

MDCG 2019-7 Guidance on Article 15 of the Medical Device Regulation (MDR) and in vitro Diagnostic Device Regulation (IVDR) regarding a “person responsible for regulatory compliance” (PRRC)

References

Regulation (EU) 2017/745 MDR: 02017R0745 — EN — 24.04.2020 — 001.001 (consolidated version)

Regulation (EU) 2017/746 IVDR: 02017R0746 — EN — 05.05.2017 — 000.003 (consolidated version)

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