The Medical Devices Coordination Group (MDCG) has published special guidance providing medical device manufacturers and other parties involved with additional recommendations and clarifications regarding how Article 15 of the Medical Device Regulation 2017/745 (MDR) and In Vitro Diagnostic Device Regulation 2017/746 (IVDR) should be applied. In particular, Article 15 sets forth the requirements related to the “person responsible for regulatory compliance (PRRC).” The whole document is divided into separate sections depending on the particular party the recommendations are addressed to.
Regulatory Compliance for Medical Device Manufacturers
In accordance with Article 15 of the MDR, the manufacturers shall have available within their organization at least one person responsible for regulatory compliance who possesses the requisite expertise in the field of medical devices. The provision further states that in order to fulfill the eligibility criteria, the person intended to be responsible for regulatory compliance should have either an appropriate diploma, certificate or other evidence of formal qualification, and at least one year of professional experience in the appropriate sphere, or four years of professional experience in regulatory affairs or in quality management systems relating to medical devices.
The MDCG also clarifies some important points related to the qualification requirements mentioned hereabove, namely:
- Any formal qualification the person has obtained outside the EU should be properly recognized by any of the EU Member States providing equivalence to the corresponding EU qualification,
- In order for the person to be allowed to refer to his/her professional experience, such experience should be related to the EU regulatory requirements.
According to the MDCG guidance, a person responsible for regulatory compliance should be employed in a particular legal entity. In the case of an organization consisting of several medical device manufacturers, each of the manufacturers should have its own responsible person. The actual location of a responsible person should align with the location of the manufacturer. In particular, a person responsible for regulatory compliance in the EU-based entity should be also located in the EU, while for the foreign entities the responsible person should be located in the appropriate jurisdiction respectively.
Regulatory Compliance for Micro and Small Medical Device Manufacturers
In accordance with the Commission Recommendation 2003/361/EC, micro and small enterprises shall not be required to have the person responsible for regulatory compliance within their organization but shall have such person permanently and continuously at their disposal.
Thus, the guidance states that in the case of the micro or small enterprises, the position of a person responsible for regulatory compliance could be subcontracted, provided that the person will meet the aforementioned qualification requirements. For instance, the manufacturer is allowed to conclude an appropriate agreement with the third-party organization, under which the person responsible for regulatory compliance would be permanently and continuously available for the manufacturer.
Regarding the requirements on the location of the responsible person, the general rules should be applied.
Regulatory Compliance for Authorised Representatives
The MDCG guidance also describes in detail the requirement related to the person responsible for regulatory compliance to be applied in the case of authorized representatives. In accordance with the Regulations, authorized representatives shall have permanently and continuously at their disposal at least one person responsible for regulatory compliance. The qualification requirements related to the formal qualification and professional experience of a person responsible for regulatory compliance are the same as in the case of medical device manufacturers – formal qualification in the appropriate sphere plus at least one year of professional experience, or at least four years of professional experience.
The authorized representative is also allowed to subcontract the position of the person responsible for regulatory compliance.
Due to the fact that the authorized representative of the foreign medical device manufacturer is always located in the EU, a person responsible for regulatory compliance should be also located in the EU.
Duties and Responsibilities of the Person Responsible for Regulatory Compliance (PRRC)
The particular roles and responsibilities of the responsible person appointed by the medical device manufacturer actually correspond with the responsibilities of the manufacturer itself. Thus, when determining the responsibilities of a PRRC, the manufacturer should refer to the appropriate EU guidance on post-market surveillance, vigilance, clinical investigations, and performance studies.
In accordance with the general rule set forth by the Regulations, the PRRC shall be responsible for:
- Ensuring that the conformity of medical devices has been properly checked before making the device available and in accordance with the quality management system established by the manufacturer,
- Preparation and keeping all necessary technical documentation, and also the EU Declaration of Conformity,
- The responsibilities of the manufacturer in the context of the post-market surveillance.
- Proper implementation of an efficient reporting system ensuring that any and all incidents and field safety corrective actions would be duly recorded and reported as required under the applicable regulations,
- Special statements to be issued by the manufacturer in case of investigational devices (by providing such a document, the manufacturer explicitly states, that the medical device in question is compliant with the general safety and performance requirements apart from certain specific aspects to be covered by the scope of the appropriate investigation and that the manufacturer has already taken all reasonable measures to mitigate risks associated with such aspects).
In case of the person responsible for regulatory compliance appointed by the authorized representative of a foreign medical device manufacturer, the particular responsibilities of such person would correspond to the appropriate obligations and responsibilities of the authorized representative itself.
The MDCG also emphasizes certain points to be taken into consideration: the person responsible for regulatory compliance appointed by the medical device manufacturer and by the authorized representative could not be the same person. In accordance with the principles established by the Regulations, an authorized representative should create an additional level of supervision and control, hence, combining both roles by one person would actually contradict these principles. It is also stated that the same approach should be applied in the case of micro and small enterprises and their authorized representatives – they are not allowed to appoint the persons responsible for regulatory compliance from the same external organization.
Summarizing the information provided here above, the MDGC guidance on requirements to and responsibilities of a person responsible for regulatory compliance provides the manufacturers and their authorized representatives with the additional clarifications regarding the most important points related to the appointment of the PRRC, and also about specific rules and limitations associated thereto. In particular, the document describes the requirements related to the formal qualification and professional experience of the person responsible for regulatory compliance, roles, and responsibilities of PRRC and specific aspects to be considered when determining the eligibility of the particular person for the purpose of an appointment as a PRRC.
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