Table of Contents
- Responsibilities
- PRRC Agreement
- Authorised Representative PRRC
- How Can Advena Help?
- Additional Guidance
The Regulations (EU) 2017/745 and (EU) 2017/746 on medical devices and IVDs present a new obligation for manufacturers and EU Authorised Representatives to appoint at least one Person Responsible for Regulatory Compliance (PRRC). Article 15 of both these Regulations provides a detailed description of the qualifications the PRRC must have and their minimum responsibilities.
The Regulation is clear that the manufacturer shall have at least one PRRC available within their organisation with the requisite expertise discussed below. This would suggest that each manufacturer must either appoint an existing employee as the PRRC, train them accordingly, or employee someone with the required experience or qualifications. However, the Regulation makes a comment on Micro and Small Enterprises, which will not be required to have a PRRC within their organisation, however they must have such a person permanently and continuously at their disposal. The definition of micro and small enterprises is given below, in accordance with Commission Recommendation 2003/361/EC:
- Micro: Employees < 10, Annual Turnover / Annual Balance Sheet Total < EUR 2 million
- Small: Employees < 50, Annual Turnover / Annual Balance Sheet Total < EUR 10 million
This makes it possible for both Micro and Small Enterprises to subcontract a person to act as the PRRC, as long as there is a continuous and permanent relationship between the PRRC and the manufacturing activities. Therefore, it is important that the designated PRRC is preferably located within the same region as the manufacturer. MDCG 2019-7 states:
For manufacturers located outside the EU, it must be assumed that the PRRC should also be located outside the EU. On the other hand, for manufacturers located in the EU, it must be assumed that the PRRC should also be located in the EU.
The contract in place between the organisation and the subcontracted PRRC should establish clear provisions which will keep the PRRC continuously and permanently available to the legal manufacturer. In the event that an organisation is made up of more than one legal manufacturer, each legal manufacturer will require its own PRRC.
The PRRC is required to have the requisite expertise in the field of medical devices, which must be demonstrated by either of the following qualifications:
(a) a diploma, certificate or other evidence of formal 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;
(b) four years of professional experience in regulatory affairs or in quality management systems relating to medical devices.
Manufacturers of custom-made devices will be allowed to demonstrate their expertise by providing evidence of at least two years of professional experience within a relevant field of manufacturing.
Any qualifications acquired from outside the EU, including degrees and certificates, must be recognised as equivalent to the corresponding qualification in the EU by an EU Member State.
Responsibilities
Article 15 of the Regulations also describes the minimum responsibilities which the PRRC shall undertake:
(a) the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released;
(b) the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date;
(c) the post-market surveillance obligations are complied with in accordance with Article 10(10);
(d) the reporting obligations referred to in Articles 87 to 91 are fulfilled;
(e) in the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued.
In essence, the PRRC must ensure that the manufacturer is complying with its obligations in accordance with its Qualify Management System (QMS) and responsibilities under the MDR. Unfortunately, there is currently little to no guidance on the specifics of these responsibilities, and the interpretation of these roles has been largely left up to the stakeholders involved.
However, it is clear that the PRRC must have sight of the technical documentation and QMS to verify that the required documentation has been drawn up and that systems are in place to acquire relevant Post-Market Surveillance (PMS) data and handle vigilance and complaints.
One may interpret the requirement in Article 15(3a) as having sight of the process in place for the manufacture of the product and also the records generated during manufacture, to ensure that the product has passed all verification processes prior to release.
It is possible to have more than one PRRC within a single organisation, and which would allow the PRRCs to share the different responsibilities listed above, as long as the responsibilities are clearly defined.
PRRC Agreement
We strongly recommend that a formal agreement is drafted up between the organisation and the PRRC clearly indicating the responsibilities which they will perform, and which is signed and dated by the PRRC. The agreement should also be backed by the PRRC’s CV and qualifications which provides sufficient evidence that they may act as the PRRC.
It should be noted that the PRRC, or team of PRRCs, will also be indicated on Eudamed during Actor Registration, so it is important that this information is kept up to date.
Authorised Representative PRRC
The EU Authorised Representative (AR) is also required to appoint a PRRC within their organisation, and they should have the requisite qualifications as discussed above, however, their responsibilities will differ to that of a manufacturer’s PRRC.
The AR’s PRRC will focus on ensuring that the AR is complying with their obligations within the mandate between them and the manufacturer, in accordance with Article 11(3) of the Regulations.
Although not directly stipulated within the EU Regulations, the PRRC for a manufacturer and the PRRC for their AR cannot be the same person. This interpretation is in line with the EU’s vision of having the AR perform additional checks on the manufacturer’s compliance with their obligations, and thus having these as the same person may cause a conflict of interest.
We would recommend that non-EU manufacturers request evidence that the AR has an appropriate PRRC in place. This may also be requested by Notified Bodies, if applicable.
How Can Advena Help?
As part of our EU Authorised Representative Service, we will verify that the PRRC appointed for your organisation is appropriate. If you have any doubt, get in touch with us and we will guide you through the requirements.
Advena Ltd. Also provide training specific to bringing you up to speed with the requirements of a PRRC. Therefore, if you have a member of your team who needs a deep understanding of the requirements and obligations within the EU Regulations, get in touch to see how we can help you.
