How to choose a PRRC

Table of Contents

How to choose a PRRC (background)

To comply with Regulation (EU) 2017/745 (more commonly known as EU MDR), one of the earliest step that the manufacturer should consider is to appoint a Person Responsible for Regulatory Compliance (PRRC). EU MDR can be downloaded here.

The reason being if this person is chosen at an early stage, he or she can plan out the activities right at the start to see how the the manufacturer could comply to CE MDR which would be much easier than say after the device has been designed or even manufactured to specifications.

The EU MDR specify the requirements in article 15 and state the qualifications required by the PRRC. An extract of that requirement is stated as below:

1.Manufacturers shall have available within their organisation at least one person responsible for regulatory compliance who possesses the requisite expertise in the field of medical devices. The requisite expertise shall 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.

Without prejudice to national provisions regarding professional qualifications, manufacturers of custom-made devices may demonstrate the requisite expertise referred to in the first subparagraph by having at least two years of professional experience within a relevant field of manufacturing.

2.Micro and small enterprises within the meaning of Commission Recommendation 2003/361/EC (1) shall not be required to have the person responsible for regulatory compliance within their organisation but shall have such person permanently and continuously at their disposal.

3.The person responsible for regulatory compliance shall at least be responsible for ensuring that: (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.

4.If a number of persons are jointly responsible for regulatory compliance in accordance with paragraphs 1, 2 and 3, their respective areas of responsibility shall be stipulated in writing.

5.The person responsible for regulatory compliance shall suffer no disadvantage within the manufacturer’s organisation in relation to the proper fulfilment of his or her duties, regardless of whether or not they are employees of the organisation.

How to choose a PRRC (MDCG guidance)

Fortunately there is a MDCG guidance that can be downloaded here. Manufacturer can use this guidance for interpretation of the regulation.

There are basically a few key points that the manufacturer should take note of:

This guidance does not stipulate the liability of the PRRC. But one should assume that the PRRC is pretty responsible for the compliance of the product in accordance to EU MDR due the responsibilities that come with the role as per subsection 3 of article 15. From experience the MR (Management representative as identified in ISO 13485) would most like to appointed as the PRRC too.
Big companies should appoint PRRC from within their organizations (this means this role should not be outsourced). Alternatively small companies can outsource this role out.
Legal manufacturer in EU should have PRRC located in EU and legal manufacturer outside of EU should have PRRC located outside of EU.
If the position of PRRC outsourced, that company should not act as the EC REP due to conflict of interest.