Person Responsible for Regulatory Compliance (PRRC) Services

The responsibilities of the PRRC encompass several crucial tasks. These include ensuring that the device conforms to regulatory standards, maintaining comprehensive technical documentation, ensuring compliance with post-market surveillance activities, recording and reporting incidents, and implementing field safety corrective actions as necessary. Additionally, the PRRC is responsible for issuing statements in the case of investigational devices under the Medical Device Regulation (MDR) or in vitro diagnostic devices intended for use in interventional clinical effectiveness studies under the In-Vitro Diagnostic Regulation (IVDR).

In accordance with Article 15(1) of both the MDR and IVDR, individuals filling the PRRC role must possess specific qualifications:

They must hold a diploma or equivalent qualification from a university in law, medicine, pharmacy, engineering, or another relevant scientific subject, They should have at least one year of professional experience in regulatory or quality management within the medical device or in vitro diagnostic device fields.
Alternatively, they should possess four years of professional experience in regulatory affairs or quality management specifically within the medical device or in vitro diagnostic device sectors.

Moreover, the PRRC’s location is ideally suggested to be in close physical and geographical proximity to the manufacturing activities as per the MDCG guidelines.

Recent advancements in AI have paved the way for diverse applications in the medical field, including AI-enabled medical devices and in vitro diagnostics solutions. Key considerations include compliance with regulatory frameworks such as the EU’s AI Act, ensuring data privacy and security, and addressing ethical implications surrounding AI use in healthcare.

Recently, the European Parliament and European Council have approved a proposal known as the “AI Act,” aimed at providing a standardized legal framework for AI use in the European Union. The regulation is currently undergoing finalization and is expected to come into force in June 2024 with a transition period of either 2 (annex III) or 3 years (annex I, including medical devices and IVD’) for high-risk AI systems.

If your device incorporates AI elements, it’s crucial to assess its classification under the Act: a) prohibited, b) high-risk, c) limited risk, or d) minimal risk. This evaluation will determine the regulatory requirements and compliance measures necessary for your device. Medical Devices and IVDs that include AI and undergo third-party conformity assessment will be considered high-risk AI by default.

To have a confident and efficient assessment of AI regulatory compliance, it is necessary to collaborate with an Authorised Representative who is well-versed in legal terms and AI-related technicalities. MedQAIR is qualified to be the perfect partner for all your medical and IVD device compliance covering those with AI features and supporting providers of High-Risk AI systems

European regulations have become increasingly intricate, notably with the implementation of the EU Medical Device Regulation (2017/745) and In Vitro Diagnostic Regulation (2017/746). To ensure companies comply with EU requirements, regulators mandate having a qualified regulatory expert available, leading to the creation of the Person Responsible for Regulatory Compliance (PRRC) role. This necessitates that the non-EU manufacturers and their EU-authorised representatives should have at least one PRRC as an employee. This individual must possess adequate qualifications for the role.

Micro- and small companies have the option to outsource PRRC activities to external experts. If you choose to outsource the PRRC role, the designated individual must possess the necessary qualifications to manage European medical device regulatory (MDR) compliance. An outsourced PRRC must be seamlessly integrated into the organization in a way that enables all involved parties to meet the requirements of the EU-MDR/IVDR. An outsourced PRRC must be seamlessly integrated into the organization in a way that enables all involved parties to meet the requirements of the EU-MDR/IVDR. Since your PRRC is viewed as a critical supplier, it’s essential to establish appropriate agreements to ensure regulatory standards are met effectively. However, uncertainties persist regarding personal liability and enforcement of this responsibility.

Note, that as a larger organisation (non-Micro / SME enterprise), you cannot directly outsource the PRRC to an external organisation, nevertheless, the PRRC may subcontract specific tasks to an external organisation, e.g. in the form of a consulting agreement.

As a last comment, it is important to note that the PRRC of the Authorised Representative cannot also function as the PRRC of the manufacturer. Therefore, at MedQAIR we ensure that these roles are separated, and a team of experts is available to effectively fulfill these roles.

In principle, the PRRC should ensure that the devices manufactured are compliant with the requirements set out in the Quality Management System of the Manufacturer. The PRRC should confirm this, for each and every release. Therefore, it may be advised that the PRRC explicitly documents such a review. As an organisation, you can appoint the sign off to the PRRc directly for the DOC, or alternatively, request the PRRC to review and co-sign on the DOC (e.g. to ensure that their review and approval for their review are documented).

As MedQAIR, our PRRCs cannot sign off on the Declaration of Conformity of the Manufacturer, since the release responsibility lies primarily with the Manufacturer. Instead our PRRC’s can co-sign on the DOC in the role of a ‘reviewer’, not as ‘approver’.