Compliance with the Medical Device Regulation (MDR) and In-Vitro Medical Regulation (IVDR) is crucial in the complex and highly regulated medical device landscape of the European Union. As a non-EU-based Manufacturer, the role of the Authorised Representative is essential in ensuring compliance.
The Person Responsible for Regulatory Compliance (PRRC) further plays a crucial role to ensure medical devices and in-vitro medical devices meet stringent safety and performance standards.
At the same time, both the Manufacturer and Authorised Representative are required to individually assign a PRRC. The PRRC may not be the same PRRC for the Manufacturer as for the Authorised Representative.
The PRRC Role Explained
‘PRRC’ stands for Person Responsible for Regulatory Compliance. According to Article 15 of the EU MDR (Regulation (EU) 2017/745 on medical devices) and the IVDR (Regulation (EU) 2017/746 on in-vitro diagnostic devices), Manufacturers (or their Authorised Representatives if the manufacturer is located outside the European Economic Area) must designate at least one PRRC within their organization. According to MDCG 2019-07, the PRRC makes sure that vigilance, post-market surveillance, and quality management system requirements in regard to the design and development, and manufacturing process are fulfilled prior to releasing medical devices onto the market.
Responsibilities of a PRRC
The PRRC is a company’s central authority for regulatory compliance. They are responsible for making sure that all procedures pertaining to the performance and safety of devices are properly documented and carried out. This entails working together with several departments within a company, including risk management, clinical evaluation, and quality assurance, to ensure compliance at every stage of the product life cycle.
According to Article 15 of the MDR and IVDR, the PRRC’s role revolves around guaranteeing compliance in five crucial areas:
(I) Conformity of Devices: The PRRC ensures that all devices designed and manufactured by the organisation meet the requirements of the organisation’s quality management system. While the PRRC is not required to carry out each step personally, they must confirm that all processes are appropriately implemented and documented.
(II) Technical Documentation: The PRRC oversees the preparation and maintenance of technical documentation, including the Declaration of Conformity. This documentation serves as evidence that a device meets all relevant regulatory requirements before entering the market.
(III) Post-Market Surveillance (PMS): The PRRC is responsible for ensuring the company fulfils its post-market surveillance obligations listed in Article 10(10) of MDR and Article 10(9) of IVDR. This involves collecting, recording, and analyzing data on the performance of devices that are already in use to confirm ongoing compliance with safety and performance standards.
(IV) Vigilance Reporting: The PRRC is tasked with ensuring the company reports serious incidents or significant issues related to device use, as per Articles 87-91 of MDR and Articles 82-86 of IVDR. This proactive approach to risk management is crucial for enhancing device safety and reliability.
(V) Compliance for Investigational Devices: The PRRC is responsible for ensuring that the statement in Section 4.1 of Chapter II of Annex XV of the MDR is issued if the company is developing an investigational device. For the IVDR, this corresponds to Section 4.1 of Annex XIV.
Key Qualifications of the PRRC
Article 15 of MDR and IVDR outlines the qualifications and professional experience that a Person Responsible for Regulatory Compliance (PRRC) must have.
- A diploma or formal qualification from a university or an equivalent course of study in law, medicine, pharmacy, engineering, or another relevant scientific subject, along with a minimum of one year of professional experience in regulatory affairs or quality management within the medical device or in vitro diagnostic device fields.
- Guidance document MDCG 2019-7 states that a university degree or certificate, as well as any other qualification obtained outside the EU, must have been accepted by an EU member state as equivalent to the EU corresponding qualification.
- Four years of professional experience in regulatory or quality management in the medical device or in vitro diagnostic device fields.
How to Choose a PRRC?
Here are a few key points that manufacturers should consider while choosing a PRRC:
1. Liability and Responsibilities
The PRRC is fundamentally responsible for ensuring product compliance with the EU MDR, as outlined in subsection 3 of Article 15.
Italian lawmakers outline the liabilities of PRRC in case of a breach of the MDR. Article 27(17) of the new Leg. Decree 137/2022 states that ‘the person responsible for regulatory compliance who violates the obligations set out in Article 15(3) of the regulation shall be subject to an administrative sanction ranging from EUR 20,000 to EUR 120,000’. This means that the PRRC faces significant penalties if it fails to:
- Ensure conformity checks are conducted per the quality management system.
- Maintain up-to-date technical documentation and the EU declaration of conformity.
- Fulfil post-market surveillance obligations (Article 10(10)).
- Comply with reporting obligations (Articles 87–91).
- Issue the declaration referred to in Annex XV, Chapter II, Section 4.1 for investigational devices.
2. Internal Appointment vs Outsourcing
Larger companies should appoint a PRRC from within their organization, which means that they cannot outsource the role.
Companies with fewer than 50 employees and an annual turnover of less than EUR 10 million (classified as micro and small enterprises under Commission Recommendation 2003/361/EC) are permitted to outsource the PRRC role to an external expert. The point to remember here is that the regulations stipulate that this person must be “permanently and continuously” at your disposal.
3. Location
For legal manufacturers based in the EU, the PRRC must also be located within the EU. Similarly, manufacturers outside the EU must ensure their PRRC is based outside the EU, aligning with their operational jurisdiction.
4. Conflict of Interest
The PRRC of a manufacturer and the European Authorised Representative cannot be the same person. Therefore, if a micro or small business employs a third-party PRRC expert, their Authorised Representative cannot outsource to the same expert, so as to avoid any conflict of interest.
The Roles and Responsibilities of an Authorised Representative
A manufacturer based outside the European Union is required to designate an Authorised Representative (AR) within the EU. The AR acts on behalf of the manufacturer and assumes responsibility for the medical devices placed on the European market. You can refer to our blogpost on this topic for a detailed breakdown of the roles and responsibilities of an Authorised Representative.
Importance of Choosing the Right PRRC and Authorised Representative
Selecting the right Person Responsible for Regulatory Compliance (PRRC) and Authorised Representative is pivotal to ensuring compliance with the stringent European Medical Device Regulation (MDR).
For the PRRC, focus on candidates with robust qualifications, extensive knowledge of MDR and IVDR, and a proven track record in regulatory affairs or quality management. Effective communication skills and a history of successful regulatory compliance are essential.
For the Authorised Representative, prioritise those with a strong presence within the EU, significant regulatory experience, and a reputation for reliability. Confirm they have the necessary resources and capabilities to manage regulatory responsibilities effectively. Conduct thorough interviews, check references, and ensure clear contractual agreements to align roles and expectations.
This careful selection process ensures that your partners can effectively work with you to navigate the complex regulatory landscape and achieve market success.
Summarising
Selecting the right PRRC and Authorised Representative is crucial for regulatory compliance and market success in the EU. By thoroughly vetting your options and making well-informed decisions, you’ll ensure these key players have your back on the regulatory front.
Are you a medical or IVD device manufacturer aiming to enter the European market? As an experienced and reliable European Authorised Representative and PRRC, MedQAIR serves as your trusted liaison with European authorities, ensuring your compliance with the EU MDR Regulation. We streamline complex regulatory processes, making your journey to market entry smoother and more efficient.
Reach out to us today and let us simplify your path to achieving regulatory compliance!
