EU MDR (2017/745)1 and EU IVDR (2017/746)2, Article 15, both stipulate specific activities that must be carried out within a manufacturer’s organization by a person responsible for regulatory compliance (PRRC) who fulfills minimum conditions of qualification.
In this post I will cover the following related to PRRCs:
- Responsible Activities
- Minimum Qualifications
- Employment Status
- Residence Location
- Documenting Responsibilities of Multiple PRRCs
- Along with a couple more additional points at the end
As we’ll see, the MDR requirements are fairly straightforward to understand with the aid of MDCG 2019-7 guidance on PRRC3.
Responsible Activities
At a minimum, per EU MDR/IVDR Article 15, Point 3, the PRRC must be responsible for:
“(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.”
Minimum Qualifications
In this section, I will cover some of the finer details of PRRC minimum qualifications. Further below for your quick reference, in Table 1 I’ve summarized the relevant minimum PRRC qualification requirements based on EU MDR/IVDR Article 15 and MDCG 2019-7 Guidance.
Of particular note is, while the MDR does allow for evidence of certain academic qualifications paired with just one year of relevant experience, it adds what may be a complicating requirement for those of us residing outside the EU. Specifically, EU MDR/IVDR Article 15, states the academic qualification must be, “recognized as equivalent by the member state concerned…”. Unfortunately, the MDCG 2019-7 Guidance does not go on to describe such a recognition process.
In researching this topic I have come across the ENIC-NARIC website, which is the joint website of the ENIC (European Network of Information Centres in the European Region) and NARIC (National Academic Recognition Information Centres in the European Union ). This website includes resources for finding information on the recognition of qualifications.
While there is an opportunity and process to have qualifications recognized, I expect it will be a much easier road for most manufacturers to appoint a PRRC with at least 4 years of professional experience in regulatory affairs or in quality management systems relating to medical devices including recent experience with EU requirements in the field.
Table 1: Summary of PRRC Minimum Qualifications
| EU MDR/IVDR Article 15 | MDCG 2019-7 Guidance |
|---|---|
| “(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” | “For the purpose of fulfilling the requirement laid down in point “a” of Article 15 (1), any qualification acquired outside the EU, including any university diplomas or certificates, should have been recognised by an EU Member State as equivalent to the EU corresponding qualification.” |
| “(b) four years of professional experience in regulatory affairs or in quality management systems relating to medical devices.” | “Professional experience in regulatory affairs or in quality management systems relating to medical devices should be related to the EU requirements in the field.” |
| “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.” | N/A |
Employment Status
A discussion of the important details referenced from the regulation is included in this section. For a quick summary of Employment Status Requirements by Organization Size see Table 2 a little further down.
The first sentence of EU MDR Article 15 states:
“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.”
While Point 2 goes on to say:
“Micro and small enterprises within the meaning of Commission Recommendation 2003/361/EC4 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.”
From the annex within 2003/361/EC, Article 2, Point 2, we come to understand that small enterprises (including micro enterprises for this purpose) are those:
“… which employs fewer than 50 persons and whose annual turnover and/or annual balance sheet total does not exceed EUR 10 million.”
MDCG 2019-7 should then be referred to for the meaning of “within their organization”:
“The person responsible for regulatory compliance (PRRC) appointed would need to be an employee of the organisation.”
Piecing all of this together, unless you’re a micro or small enterprise the PRRC must be an employee of your organization.
If your organization qualifies as a micro or small enterprise, then you may set up an agreement with a person outside of your organization. In this case, you should document the responsibilities and qualifications of the outside person and have their written acceptance of the PRRC role.
Table 2: Summary of Employment Status Requirements by Organization Size
| Organization Size | Criteria | Employment Status |
|---|---|---|
| Micro and Small | < 50 Employees and < 10 million EUR annual turnover (sales) and/or annual balance sheet total | PRRC not required to be an employee but must be permanently and continuously available (document in writing) |
| Medium and larger | > 50 Employees | PRRC must be an employee |
Residence Location
EU MDR Article 15 is not much help in determining where a PRRC must reside. For this, we must look to MDCG 2019-7 for guidance.
This guidance states that, regardless of organization size, the PRRC should be located:
- within the EU if the manufacturer is in the EU; and
- outside the EU if located outside of the EU.
This appears to leave it wide open if the manufacturer is located outside the EU. But it is important that there is a permanent and continuous nature of the relationship between the PRRC and the manufacturing activities. So be prepared to defend your solution to your individual notified body.
What if there is more than one PRRC?
Looking back at the responsible activities of the PRRC covered at the beginning of this article, I expect in smaller organizations that just one person can faithfully be considered the PRRC. In this case, responsibilities may be verified through an organization chart and a job description.
But for larger organizations, it is likely that the PRRC responsibilities may be divided among more than one individual. Often aspects of these requirements are split between separate quality, regulatory, and perhaps clinical departments. In cases such as these EU MDR Article 15 requires the responsibilities of each PRRC to be documented in writing.
To keep things simple, even if there is just one PRRC, I recommend formally appointing PRRC(s) in writing with the responsibilities clearly described along with reference to evidence of their qualifications.
Additional Points
- If your organization has more than one legal manufacturer under a parent company then each legal manufacturer must have its own PRRC.
- An Authorized representative cannot serve as your organization’s PRRC.
Summary
With the adoption of EU MDR and IVDR the EU commission has made it clearer than ever that manufacturers are expected to maintain responsibility for compliance with regulatory requirements.
To emphasize this point there is a new requirement for a person responsible for regulatory compliance (PRRC), that meets specific minimum qualification criteria, to be at the continuous disposal of the organization.
The PRRC, which may be more than one individual, is responsible for specific activities ranging from ensuring conformity of devices are checked, technical documentation and EU declaration of conformity are kept up to date, and certain post-market surveillance and reporting obligations are fulfilled.
The MDCG has issued guidance, summarized in this post, that should be referred to for more detail regarding the minimum qualification requirements, employment status, and residence location of the PRRC.
References:
1REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
2 REGULATION (EU) 2017/746 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU
3MDCG 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)
4Commission Recommendation 2003/361/ΕC of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises.