Author: Suzanne Broussard | September 07, 2020
The newly created Person Responsible for Regulatory Compliance (PRRC) position is a unique regulatory requirement that applies only to the European Union, and is a key area of responsibility for a person or persons under the Medical Device Regulation (MDR) and In Vitro Device Regulation (IVDR).
The motivation for creating the PRRC positions is so that there is a qualified regulatory expert directly responsible for the manufacturing and the market surveillance and reporting systems to ensure the company is meeting the European Union requirements.
The Regulations have a clear desire to add an additional level of scrutiny to the supervision and control of the manufacturing of medical devices, as well as relevant post-market surveillance and vigilance activities. Thus, the PRRC role is purposefully a unique position from the European Union Authorized Representative.
The requirements, qualifications, and responsibilities of the PRRC is outline in Article 15 of both Regulation (EU) 2017/745 MDR and Regulation (EU) 2017/746 (IVDR).
Article 15 of both MDR and IVDR state:
“Manufacturers shall have available within their organisation at least one person responsible for regulatory compliance who possesses the requisite expertise in the field of in vitro diagnostic medical devices.”
Manufacturers will be looking closely at how to fill these positions. Parent companies with more than one legal manufacturer under the organization needs to ensure that each legal manufacturer has its own PRRC. Micro or small business enterprises have the option to contract a PRRC (EU definition of micro and small businesses can be found in Regulation 2003/361/1C).
The PRRC has at least 5 responsibilities clearly outline in Article 15.
- Checking the conformity of medical devices in accordance with the quality management system (QMS) before the medical device is released;
- Drawing up the technical documentation and keeping it up to date;
- Making sure the post-market surveillance obligations are in compliance with EU regulations Article 10(9);
- Fulfilling the reporting obligations referred to in reporting of serious incidents and field safety corrective actions (Article 82) and implementing acts (Article 86)
- Ensuring the statement that investigational devices (Section 4.1 of Annex XIV) meet the GSPRs is signed.
The Medical Device Coordination Group (MDCG) released a guidance document on 20 June 2020 addressing some of the questions about the person responsible.
Medical Devices: Guidance document
MDCG 2019-7 Guidance on Article 15 of the Medical Device Regulation (MDR) and in vitro Diagnostic Device Regulation (IVDR) regarding a “person responsible for regulatory compliance” (PRRC)
The guidance clarifies the training and/or professional experience necessary to hold the position of PRRC. The qualifications for this role can be met with either education (certification/diploma) or experience. The PRRC does not have to perform all these duties themselves but is responsible for their completion.
To support those with the role of PRRC, a new not-for-profit European association has been launched – TEAM-PRRC. The association represents it members at the highest level – the European Commission and Medical Device Coordination group (MDCG). TEAM-PRRC plans to provide the framework and rigorous analysis required to gain insight and influence the guidance that is being developed for the PRRC role. TEAM-PRRC aims to:
- Bring together all people with PRRC functions;
- Exchange experience on issues faced by PRRC in their daily activities; propose and exchange solutions.
- Establish, maintain, and develop a high level of professionalism of PRRC.
- Exchange information with health authorities in charge of national, European, and international regulation; promote understanding of PRRCs’ responsibilities to other stakeholders.
- Act as a moderator and support PRRCs in conflicts or disputes encountered during their day-to-day activities.
- Aim for enhancement of Public Health.
- Pursue for mutual assistance between TEAM-PRRC members.
The newly created role of PRRC will bring many challenges for manufacturers and regulatory specialist, and there is a lot at stake for those considering taking this role. The regulations mandate penalties that are decided on the level of the member states for noncompliance and individuals taking this role need to be aware of the potential consequences.
Criterion Edge is dedicated to providing support for medical device and pharmaceutical manufacturers, and we do this in part by keeping device manufacturers up to date on current events. For more information on the new MDR guidance documents, extension, and grace period, see our previous posts.
Either way, Criterion Edge is prepared to provide expert medical writers to facilitate a timely submission.