PRRC - Person responsible for regulatory compliance

PRRC - Person responsible for regulatory compliance

PRRC - Person responsible for regulatory compliance

Medical Device Regulation – MDR (EU 2017/745) and In Vitro Diagnostic Regulation – IVDR (EU 2017/746) require companies to have a Person Responsible for Regulatory Compliance (PRRC) at their disposal. PRRC is a regulatory expert whose responsibility is to ensure that the company is meeting applicable medical device requirements in the EU.

PRRC is a part of checks and balances needed to ensure the regulatory compliance including released devices, the post-market surveillance (PMS) and vigilance activities. If a manufacturer is located outside the EU and an Authorized Representative (AR) is required, PRRC of the AR provides the secondary control of the regulatory compliance in the EU.

The provisions related to the Person Responsible for Regulatory Compliance in the EU are set forth in MDR/IVDR Article 15 and the 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)».

Регистрация в EUDAMED

Need a PRRC for the EU?

Contact us right now:

+49 176 67510274

info@mdrc-consulting.com

Qualifications of the PRRC

The required qualifications and professional experience of the PRRC are specified in Article 15 and further elaborated by the MDCG Guidance 2019-7. The sum of required qualifications must be either of the following:

  1. 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.
    Any qualification acquired outside the EU, including any university diplomas or certificates, should be recognized by an EU Member State as equivalent to the EU corresponding qualification.
  2. PLUS

    At least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices.1 The professional experience in regulatory affairs or in quality management systems should be related to the EU requirements in the field – MDCG Guidance 2019-7.

    OR

  3. Four years of professional experience in regulatory affairs or in quality management systems relating to medical devices/ in vitro diagnostic medical devices.2 The professional experience in regulatory affairs or in quality management systems is expected to be recent and related to EU medical devices regulation.

How to appoint a PRRC

According to MDR/IVDR Article15 and the MDCG Guidance 2019-7 manufacturers are required to have available within their organization at least one PPRC with proper expertise in the field of medical devices or in vitro medical devices.

The MDCG Guidance 2019-7 explains that this would need to be an employee of the organization in case of larger organizations that employ at least 50 persons and whose annual turnover and/or annual balance sheet total exceeds EUR 10 million.

Micro and small manufacturers are permitted to designate an external subcontractor as their PRRC. Thay may subcontract the responsibilities of a PRRC to a third party, as long as the qualification criteria are met. In these cases 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 the Person Responsible for Regulatory Compliance. The contract should also mention the relevant person’s qualifications demonstrating compliance with provisions of Article 15.

If an organization has more than one legal manufacturer under the parent company, it would need to ensure that each legal manufacturer has its own PRRC.

MDGC Guidance 2019-7 emphasizes the importance of establishing a close linkage of a permanent and continuous nature between the PRRC and the manufacturing activities. For this reason, for manufacturers located outside the EU it is assumed that the PRRC should also be located outside the EU. On the other hand, for manufacturers within the EU it is assumed that the PRRC should also be located in the EU.

Manufacturers may have more than one PRRC. In such case the functions and responsibilities of company's PRRCs can be divided on the company’s needs and structure. For example, one PRRC can be responsible for the technical documentation, another PRRC provide the conformity of the released devices etc. Different PRRCs can be appointed in manufacturing sites that are geographically separated.

Manufacturers having more than one PRRC are expected to document the competencies and respective areas of responsibility and to register in EUDAMED each person who has been appointed as PRRC.

Responsibilities of a PRRC

The PRRC is required to ensure that at least the following activities are in compliance with the regulations:

  • 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
  • the reporting obligations referred to in Articles 87 to 91 are fulfilled
  • in the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued

Companies' responsibility to their PRRC

Manufacturers and Authorized Representatives are expected to identify the best person or persons to provide the regulatory compliance in the EU. They should start adapting their own systems to cover the requirements and truly invest in implementing the PRRC-requirement thoughtfully and in such a way as to genuinely enhance the compliance culture of the company. Senior management have a responsibility to appreciate the importance of defining the role of PRRC correctly and providing the necessary support and resources for the PRRC.


1. Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices

2. Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic

3. 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)

We are here to help you place your medical devices on your strategic markets.

+49 176 67510274

info@mdrc-consulting.com

Medical Device Regulation – MDR (EU 2017/745) and In Vitro Diagnostic Regulation – IVDR (EU 2017/746) require companies to have a Person Responsible for Regulatory Compliance (PRRC) at their disposal. PRRC is a regulatory expert whose responsibility is to ensure that the company is meeting applicable medical device requirements in the EU.

PRRC is a part of checks and balances needed to ensure the regulatory compliance including released devices, the post-market surveillance (PMS) and vigilance activities. If a manufacturer is located outside the EU and an Authorized Representative (AR) is required, PRRC of the AR provides the secondary control of the regulatory compliance in the EU.

The provisions related to the Person Responsible for Regulatory Compliance in the EU are set forth in MDR/IVDR Article 15 and the 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)».

Регистрация в EUDAMED

Need a PRRC for the EU?

Contact us right now:

+49 176 67510274

info@mdrc-consulting.com

Qualifications of the PRRC

The required qualifications and professional experience of the PRRC are specified in Article 15 and further elaborated by the MDCG Guidance 2019-7. The sum of required qualifications must be either of the following:

  1. 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.
    Any qualification acquired outside the EU, including any university diplomas or certificates, should be recognized by an EU Member State as equivalent to the EU corresponding qualification.
  2. PLUS

    At least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices.1 The professional experience in regulatory affairs or in quality management systems should be related to the EU requirements in the field – MDCG Guidance 2019-7.

    OR

  3. Four years of professional experience in regulatory affairs or in quality management systems relating to medical devices/ in vitro diagnostic medical devices.2 The professional experience in regulatory affairs or in quality management systems is expected to be recent and related to EU medical devices regulation.

How to appoint a PRRC

According to MDR/IVDR Article15 and the MDCG Guidance 2019-7 manufacturers are required to have available within their organization at least one PPRC with proper expertise in the field of medical devices or in vitro medical devices.

The MDCG Guidance 2019-7 explains that this would need to be an employee of the organization in case of larger organizations that employ at least 50 persons and whose annual turnover and/or annual balance sheet total exceeds EUR 10 million.

Micro and small manufacturers are permitted to designate an external subcontractor as their PRRC. Thay may subcontract the responsibilities of a PRRC to a third party, as long as the qualification criteria are met. In these cases 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 the Person Responsible for Regulatory Compliance. The contract should also mention the relevant person’s qualifications demonstrating compliance with provisions of Article 15.

If an organization has more than one legal manufacturer under the parent company, it would need to ensure that each legal manufacturer has its own PRRC.

MDGC Guidance 2019-7 emphasizes the importance of establishing a close linkage of a permanent and continuous nature between the PRRC and the manufacturing activities. For this reason, for manufacturers located outside the EU it is assumed that the PRRC should also be located outside the EU. On the other hand, for manufacturers within the EU it is assumed that the PRRC should also be located in the EU.

Manufacturers may have more than one PRRC. In such case the functions and responsibilities of company's PRRCs can be divided on the company’s needs and structure. For example, one PRRC can be responsible for the technical documentation, another PRRC provide the conformity of the released devices etc. Different PRRCs can be appointed in manufacturing sites that are geographically separated.

Manufacturers having more than one PRRC are expected to document the competencies and respective areas of responsibility and to register in EUDAMED each person who has been appointed as PRRC.

Responsibilities of a PRRC

The PRRC is required to ensure that at least the following activities are in compliance with the regulations:

  • 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
  • the reporting obligations referred to in Articles 87 to 91 are fulfilled
  • in the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued

Companies' responsibility to their PRRC

Manufacturers and Authorized Representatives are expected to identify the best person or persons to provide the regulatory compliance in the EU. They should start adapting their own systems to cover the requirements and truly invest in implementing the PRRC-requirement thoughtfully and in such a way as to genuinely enhance the compliance culture of the company. Senior management have a responsibility to appreciate the importance of defining the role of PRRC correctly and providing the necessary support and resources for the PRRC.


1. Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices

2. Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic

3. 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)


We are here to help you place your medical devices on your strategic markets.

+49 176 67510274

info@mdrc-consulting.com


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