The person responsible for regulatory compliance (prrc)
The requirements to obtain the conformity with Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR) include something new compared to the previous regulations: this concerns the obligation by manufacturers to appoint a Person Responsible for Regulatory Compliance (PRRC).
This novelty is the more important because the same obligation is also imposed on authorised representatives, now playing a role that is more complex and involving more (even jointly) responsibilities compared to the provisions of Directive EC 93/42 (MDD).
Which are the tasks of the prrc?
According to article 15 of the MDR and IVDR, the PRRC has the task to ensure at least that:
- The conformity of the devices is appropriately controlled in compliance with the quality management system (SGQ) based on which the devices are manufactured before their release;
- The technical documentation and the EU declaration of conformity are drafted and updated;
- The post-market surveillance obligations as per article 10.10 (manufacturer’s obligations) are met;
- The reporting obligations as per articles 87 to 91 (vigilance) are met;
- In case of investigational devices, the declaration as per annex XV, chapter II, 4.1 is released (clinical investigation)
Which are the prrc skills?
MDR and IVDR define the minimum requirements and qualifications required to act as PRRC, i.e. alternatively:
- a diploma, certificate or other 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/in vitro diagnostics;
- four years of professional experience in regulatory affairs or in quality management systems relating to medical devices/in vitro diagnostics, in case of no degree in another relevant scientific discipline.
On this regard, the document MDCG 2019-07 – Guidance on Article 15 of the medical device regulation (MDR) and in vitro diagnostic device regulation (IVDR) on a ‘person responsible for regulatory compliance’ (PRRC) – is available, providing information and clarifications regarding the minimum qualifications to act as PRRC.
Can organisations appoint an external prrc?
Manufacturers and authorised representatives can appoint an external PRRC only when they fall into the category of micro enterprises (employing fewer than 10 persons and whose annual turnover and/or annual balance sheet total does not exceed EUR 2 million) or small-sized enterprises (employing fewer than 50 persons and whose annual turnover and/or annual balance sheet total does not exceed EUR 10 million), as per the Commission Recommendation 2003/361/CE, delegating to a third subject the PRRC responsibilities by a specific agreement. In any case, the PRRC is bound to be available permanently and continuously.
When is it worth to outsourcing?
Based on the information provided in this short post, it is certainly desirable to deeply reflect on the appointment of the PRRC considering the complexity of the subject and the continuous regulatory updates affecting the sector of the medical devices.
The first appropriate question to ask regards the level of complexity that the PRRC shall face while performing their duties in the specific context of the company where they are going to operate.
The answer depends on several factors, including:
- the frequency of the device releasing,
- the number of new variants of a device marketed every year,
- the complexity of the manufacturing processes,
- the complexity of the controls to ensure the device conformity,
- the nature of the involved devices (for instance, their risk class), the organization and complexity of the technical documentation.
Answering all these questions will allow to understand the actual burden of the Person chosen for this role.
This is an essential point: if, for instance, such burden is too much, it should be considered that by deciding to assign the role of PRRC to one employee, that employee will not be able to perform their usual tasks.
In case of reduced or little structured staff, this could become an issue.
The second point to be taken into account is that the PRRC cannot hierarchically be dependent from any role regarding the manufacturing or the quality control.
If so, it would not be possible to ensure their independence in the control of the device conformity before their release on the market.
In the light of the above, especially for small companies, an external consultant could be the simplest solution.
Di Renzo Regulatory Affairs is a company specialising in consultancy and support of companies operating in the sector of medical devices and in vitro diagnostics. Our mission is to help our client to obtain all authorisations required to market their products on different markets, ensuring the compliance with the regulations in force as well as the patients’ safety.
Do no not hesitate to contact us if you are interested in knowing more about our PRRC service. We will be glad to answer your questions and to offer you a custom-made solution based on your needs.
Written on 07/02/2024 by Felisiano Cipressi
