Person Responsible for Regulatory Compliance (PRRC)

What is PRRC?

Having a PRRC is a mandatory requirement according to Article 15 of the (EU)MDR 2017/745. A PRRC stands for Person Responsible for Regulatory Compliance. This role is crucial within organizations, particularly in industries such as the medical sector, where compliance with regulations is essential. The PRRC is responsible for ensuring that the organization adheres to relevant laws and regulations governing its operations. This includes tasks such as staying updated on regulatory changes, monitoring technical documentation, overseeing post-market surveillance, and reporting incidents. The PRRC plays a key role in maintaining compliance and ensuring that the organization operates within the bounds of the law.

The biggest challenges for a PRRC

Outsourcing the role of the PRRC

Outsourcing the role of the PRRC to our specialized consultants can offer several benefits:

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PRRC & MDR

The connection between the PRRC (Person Responsible for Regulatory Compliance) and the MDR (Medical Device Regulation) is pivotal in ensuring adherence to regulatory standards within the medical device industry. The PRRC serves as the central figure responsible for overseeing compliance with the MDR requirements layed down in (EU)MDr 2017/745 Article 15. As mandated by the MDR, medical device manufacturers must appoint a PRRC who possesses the requisite expertise and authority to ensure conformity with regulatory obligations. The PRRC plays a crucial role in facilitating communication between the manufacturer and regulatory authorities, ensuring that all necessary procedures and documentation are in place to meet MDR standards.

Moreover, the PRRC is responsible for keeping abreast of evolving regulatory requirements and industry best practices, thereby guiding the organization in maintaining compliance with the MDR. Through their expertise and vigilance, the PRRC helps mitigate risks associated with non-compliance and contributes to the overall safety and effectiveness of medical devices in the market.

In essence, the PRRC acts as the linchpin connecting the organization’s regulatory compliance efforts with the stringent requirements outlined in the MDR, fostering a culture of accountability and diligence in ensuring the safety and efficacy of medical devices.

PRRC Responsibilities

Article 15 of the Medical Device Regulation (MDR) outlines the responsibilities of the Person Responsible for Regulatory Compliance (PRRC). According to this article, the PRRC is responsible for ensuring compliance with the MDR and other relevant regulatory requirements. Specifically, their responsibilities include:

• Ensuring that the conformity of devices is appropriately assessed in accordance with the requirements of the MDR before they are placed on the market or put into service.
• Overseeing the ongoing conformity of devices throughout their lifecycle, including post-market surveillance activities.
• Ensuring that the technical documentation and the EU declaration of conformity are drawn up and kept up to date.
• Ensuring the reporting obligations in case of (reportable) incidents are fulfilled
• Keeping up-to-date with changes in the regulatory landscape and ensuring that the organization is aware of and compliant with any new requirements.

Overall, the PRRC plays a crucial role in ensuring that medical device manufacturers comply with the regulatory requirements outlined in the MDR, thereby contributing to the safety and effectiveness of medical devices placed on the market within the European Union.

PRRC requirements

Manufacturers must appoint someone in their organization to oversee regulatory compliance for medical devices. This person needs to have the following education or expertise:

• 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;
• 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.

Micro and small enterprises within the meaning of Commission Recommendation 2003/361/EC 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.

but also:

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 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;
• four years of professional experience in regulatory affairs or in quality management systems relating to medical devices.