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)».
Need a PRRC for the EU?
Contact us right now:
+357 22253765
info@mdrc-consulting.com
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:
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
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.
The PRRC is required to ensure that at least the following activities are in compliance with the regulations:
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)
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+357 22253765
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)».
Need a PRRC for the EU?
Contact us right now:
+357 22253765
info@mdrc-consulting.com
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:
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
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.
The PRRC is required to ensure that at least the following activities are in compliance with the regulations:
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)
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