This document has been approved by the Medical Device Coordination Group (MDCG) created by article 103 of EU Regulation 2017/745.
It clarifies the role and responsibilities of the “Person Responsible for Regulatory Compliance” (PRRC). It also specifies the location of the PRRC.
Analysis
Article 15
The person responsible for ensuring regulatory compliance.
Manufacturers have within their organisation at least one person responsible for ensuring regulatory compliance, with the required expertise in the medical device sector. This expertise must be certified by one of the following qualifications:
a) a degree, certificate or other formal certification document recognising university studies in law, medicine, pharmacy, engineering or other relevant scientific discipline, or a course recognised as equivalent by the Member State concerned, and professional experience of at least one year in regulation or quality management systems in the medical devices sector,
b) professional experience of four years in regulation or quality management systems in the medical devices sector. Without prejudice to the national provisions relating to professional qualifications, manufacturers of customised devices can certify that they have the required expertise, referred to in the first paragraph by providing proof of professional experience of at least two years in the relevant manufacturing sector.
CLARIFICATION ON QUALIFICATIONS
To meet the requirements listed in point a of Article 15, Paragraph 1, any qualification acquired outside the European Union, including degrees and university certificates, must be recognised as equivalent to the qualifications applicable to the Member State concerned.
Professional experience in regulation or quality management systems in the medical device sector must meet EU requirements for the field concerned.
Meaning of “within their organisation”
The Person Responsible for Regulatory Compliance (PRRC) must be an employee of the organisation.
Organisations with more than one legal manufacturer
Organisations with more than one legal manufacturer under their authority must ensure that each legal manufacturer has its own PRRC.
Can the PRRC be located outside the EU?
As regards the location of the PRRC, it is important that a close link, of a permanent and continuous nature, is established between the PRRC and manufacturing activities.
The PRRC for manufacturers located outside the EU must therefore be located outside the EU and inside the EU for manufacturers located inside the EU.
2. Micro and small enterprises are not obliged to have, within their organisation, a Person Responsible for Regulatory Compliance but such a person must be permanently and uninterruptedly at their service.
Meaning of “permanently and uninterruptedly at their service”
Micro and small enterprises can subcontract the responsibilities of the Person Responsible for Regulatory Compliance to a third party, as long as the qualification criteria are met and the manufacturer can demonstrate and document how they are meeting their legal obligations.
For example, the PRRC can form part of an external organisation with which the manufacturer has entered into a contract containing provisions that guarantee the permanent and continuous availability of this party. The contract must mention the qualifications of the person concerned, that make them compliant with points a and b of Article 15, Paragraph
Can the PRRC be located outside the EU?
For micro and small enterprises located inside the UE, this person must be located inside the EU.
6. Agents must have, permanently and uninterruptedly, at least one person responsible for ensuring regulatory compliance, with the required expertise in the medical device sector in the Union. This expertise must be certified by one of the following qualifications: a) a degree, certificate or other formal certification document recognising university studies in law, medicine, pharmacy, engineering or other relevant scientific discipline, or a course recognised as equivalent by the Member State concerned, and professional experience of at least one year in regulation or quality management systems in the medical devices sector, b) professional experience of four years in regulation or quality management systems in the medical devices sector.
Meaning of “permanently and uninterruptedly at their service”
The agent can subcontract to a third party the responsibilities of the PRRC, as long as the qualification criteria are met and the manufacturer can demonstrate and document how they are meeting their legal obligations. For example, the PRRC can belong of an external organisation with which the agent has established a contract containing the necessary provisions to guarantee the permanent and uninterrupted availability of this party. The contract must also mention the qualifications of the person concerned.
Can the PRRC be located outside the EU?
Since the agent is located inside the EU, this person must be located inside the EU.
Roles and responsibilities of the PRRC of a manufacturer
The PRRC must at least ensure that:
- Compliance of the devices has been appropriately verified, in accordance with the quality management system under which the devices are manufactured, prior to their release,
- The technical documentation and compliance declaration has been drawn up and kept up to date,
- Post-Market Surveillance obligations are complied with,
- Obligations relating to the reporting of incidents are complied with,
- For devices under investigation, the declaration that the device in question is compliant with the general requirements relating to safety and performance, irrespective of the aspects under clinical investigation, and that, in relation to these aspects, every precaution has been taken to protect the health and safety of the participant.
Roles and responsibilities of the PRR
The PRRC must ensure that the tasks stipulated in the agent’s contract are completed.
Can the same person be the PRRC of a manufacturer and of its agent?
The PRRC of an agent and of a manufacturer located “outside the EU” cannot be the same person.
The Regulation sets out clearly that the agent represents an additional level of control, ensuring that device manufacturing surveillance and checks, as well as the market surveillance activities and vigilance are carried out adequately.
If the two roles were assumed by the same person, the additional level of control would be compromised.
For this reason, the PRRC of a microenterprise or small enterprise and the PRRC of the agent of this same enterprise must not belong to the same external organisation.