MDCG 2021-27 Updated: Q&A on MDR/IVDR Articles 13 (Importers) & 14 (Distributors)
20 December 2023
MDCG 2023-7: Clinical Investigation Exemptions & Claiming Equivalence
4 January 2024- Overview of Changes
- Clarification on PRRC qualifications for Manufacturers
- Clarification on “permanently and continuously at their disposal”
- Clarification on the PRRC’s role and responsibilities
- New section: “PRRC shall suffer no disadvantage”
- Clarification on PRRC qualifications for EU Authorized Representatives (ARs)
- New section: “Entities assuming the obligations of a manufacturer”
- New section: “Registration of the PRRC in EUDAMED”
MDCG 2019-07, on the Person Responsible for Regulatory Compliance (PRRC), was originally published in June 2019. It has now been revised (December 2023).
MDCG 2019-07 Rev. 1 is available: HERE
Overview of Changes
Fundamentally, the newly revised MDCG guidance remains consistent with the original version, i.e., there is no major shift in perception of the role. However, the revision provides further explanation and clarification on certain points.
Below is a general overview of the updated document. Please refer to the guidance for a full overview of the changes.
Clarification on PRRC qualifications for Manufacturers
The MDR/IVDR Article 15(1) require PRRCs to hold one of the two following minimum qualifications:
- “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;
- four years of professional experience in regulatory affairs or in quality management systems [QMS] 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.”
The revised MDCG guidance provides an additional explanation regarding:
- What constitutes a ‘course of study’ in “law, medicine, pharmacy, engineering, or other relevant scientific discipline”, which could be accepted as an alternative to a university degree — the course of study should be recognized as equivalent to a university diploma in at least one EU member state.
- Additional explanation regarding what constitutes the minimum professional experience in regulatory affairs/QMS — the experience should be related to the EU and be substantiative and recent.
- The professional experience for a custom-made device manufacturer’s PRRC should cover regulatory and/or QMS aspects. Further, it is recommended that the experience be relevant to the class of custom-made devices, particularly for implantable devices.
Clarification on “permanently and continuously at their disposal”
This update is primarily related to micro and small manufacturers, who outsource the role of the PRRC instead of appointing someone within their own company.
The newly added text has been italicized below:
“The micro or small enterprise may subcontract the responsibilities of a person responsible for regulatory compliance to a third party, so long as the qualification criteria are met and the manufacturer can demonstrate and document how they can meet their legal obligations. For example, the PRRC may be part of an external organisation, with which the manufacturer has established a contract laying down provisions so as to ensure the permanent and continuous availability of the PRRC.
This may clarify how the availability requirements are intended to be met so the duties of the PRRC can be carried out effectively (e.g., that the PRRC should be available to perform its operational duties and react in a timely manner, whilst not necessarily implying 24-hour availability on a daily basis).”
Clarification on the PRRC’s role and responsibilities
The below text was newly added:
“The PRRC has a key role in the manufacturer’s organisation in verifying the manufacturer’s compliance with the Regulations. As such, the manufacturer should involve the PRRC in the processes it deems relevant and enable the PRRC to receive all necessary information (e.g., any identified non-conformities), for the PRRC to perform its tasks effectively.”
“The demonstration of conformity of devices with the Regulations remains the responsibility of the manufacturer. The PRRC within their role however is expected to ensure that devices for release by the manufacturer have followed procedures established in its quality management system before being placed on the market. The PRRC may carry out this activity for example, by means of auditing or sampling the following (non-exhaustive examples):
- the required documentation exists and may assess the relevance and consistency of these documents (i.e., the presence of a document is not sufficient to conclude that it complies with the regulatory requirements);
- the technical documentation contains all documents quoted in the checklist of general safety and performance requirements;
- the relevant test reports are valid and according to the applicable versions of the standards used; when there are product changes10 , the technical documentation has been updated and contains the documents reflecting the change;
- all verifications, validations and other tests provided for in the QMS have been carried out before devices are released.”
To assess the post-market surveillance obligations are complied with:
“…the PRRC may assess the relevance and functioning of the post-market surveillance system and whether it enables appropriate data collection in order to support the continuous maintenance of device safety and performance or improvement thereof.”
“The PRRC should also ensure that the vigilance reporting obligations are fulfilled, including the systematic reporting of serious incidents, field safety corrective actions and trend reporting.”
New section: “PRRC shall suffer no disadvantage”
“The PRRC should not suffer any disadvantage and this may include, for example dismissal or, being penalised for performing their tasks dutifully.”
Clarification on PRRC qualifications for EU Authorized Representatives (ARs)
The requirements for the EU AR are similar to those noted in the section ‘Clarification on PRRC qualifications for Manufacturers’.
New section: “Entities assuming the obligations of a manufacturer”
This relates to MDR/IVDR Article 16, ‘Cases in which obligations of manufacturers apply to importers, distributors or other persons’.
This article is generally applicable when: 1) a company other than the manufacturer, makes the device available on the Union market in their own name; 2) changes the intended purpose of the device; or 3) modifies a device already placed on the Union market.
The revised MDCG guidance clarifies that in the above situation, Article 15’s requirement to appoint a PRRC will apply.
Further, it states that the PRRC requirements also apply in the case of MDR Article 17 (‘single-use devices and their reprocessing’) and Article 22(4) )‘systems and procedure packs’).
New section: “Registration of the PRRC in EUDAMED”
Manufacturers, System/Procedure Pack Producers, and Authorized Representatives are required to register in EUDAMED (once fully functional). The name and contact details for the PRRC is required to complete this registration.
If there is a change to the PRRC (e.g., change to contact details, or appointment of a new PRRC), then Manufacturers, System/Procedure Pack Producers, and Authorized Representatives should update this information within one week.
