PRRC plays a crucial role in ensuring all necessary checks for regulatory compliance, encompassing documentation, released devices, QMS, post-market surveillance, and vigilance activities.

For manufacturers located outside the EU who require an Authorised Representative (AR), the AR's PRRC provides an additional layer of regulatory oversight in the EU, reinforcing compliance measures.

The requirements governing the Person Responsible for Regulatory Compliance in the EU are outlined in MDR/IVDR Article 15, and further detailed in the MDCG 2019-7, titled "Guidance on Article 15 of the Medical Device Regulation and in vitro Diagnostic Device Regulation regarding a person responsible for regulatory compliance (PRRC)". These guidelines set the standard for the critical role PRRC fulfills in maintaining regulatory compliance and ensuring the safe and effective use of medical devices in the EU market.

How to appoint a PRRC

As per MDR/IVDR Article 15 and the MDCG Guidance 2019-7, it is mandatory for manufacturers to designate at least one PRRC within their organisation who possesses the necessary expertise in the field of medical devices or in vitro medical devices.

The MDCG Guidance 2019-7 further clarifies that in the case of larger organisations employing at least 50 individuals, with an annual turnover and/or annual balance sheet total exceeding EUR 10 million, the PRRC must be an employee of the organisation itself. This ensures that the PRRC is an integral part of the company's team, facilitating seamless communication and swift decision-making related to regulatory compliance matters.

Micro and small manufacturers have the option to appoint an external subcontractor as their PRRC. They are allowed to delegate the responsibilities of a PRRC to a qualified third-party, provided that the required qualification criteria are met. In such cases, the PRRC may be affiliated with an external organisation, subject to a contractual agreement with the manufacturer to ensure a continuous and permanent presence of the Person Responsible for Regulatory Compliance. The contract should explicitly state the relevant person's qualifications, ensuring compliance with the provisions outlined in Article 15.

In cases where an organisation comprises multiple legal manufacturers under a parent company, it is crucial to ensure that each legal manufacturer has its own designated PRRC.

The MDGC Guidance 2019-7 underscores the significance of establishing a strong and continuous link between the PRRC and the manufacturing activities. Consequently, for manufacturers located outside the EU, it is expected that their PRRC will also be situated outside the EU. Conversely, for manufacturers within the EU, it is assumed that their PRRC will likewise be located within the EU.

Manufacturers have the flexibility to appoint multiple PRRCs based on their specific needs and organisational structure. This allows for the division of functions and responsibilities among the PRRCs according to the company's requirements. For instance, one PRRC may focus on overseeing technical documentation, while another PRRC ensures conformity of the released devices. In cases where manufacturing sites are geographically dispersed, separate PRRCs can be designated for each site.

To ensure transparency and compliance, manufacturers with multiple PRRCs are required to document the competencies and respective areas of responsibility of each PRRC. Additionally, each appointed PRRC must be registered in EUDAMED, the European Databank on Medical Devices. This registration process serves to validate the qualifications and responsibilities of each PRRC, contributing to a more efficient and organised regulatory compliance framework.

PRRC of a group, holding, parent companies and subsidiaries (daughter companies)

According to Article 15 of MDR or Article 15 of IVDR, the obligation to have a Person Responsible for Regulatory Compliance (PRRC) available within the organisation pertains to each individual legal manufacturer. Consequently, if a company has multiple legal manufacturers under its parent entity, it must ensure that each legal manufacturer has its own designated PRRC.

In the case where a manufacturer distributes its products through several legal entities, relying on a single PRRC within the parent company will not suffice. Each distinct legal manufacturer under the parent company must independently appoint its own PRRC.

However, it's important to note that subsidiaries and daughter companies functioning solely as distributors or importers in the EU are exempt from the PRRC requirement. This is because distributors and importers are not mandated to have a PRRC as part of their regulatory obligations.