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
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.
The MDR/IVDR Article 15(1) require PRRCs to hold one of the two following minimum qualifications:
The revised MDCG guidance provides an additional explanation regarding:
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 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):
To assess the post-market surveillance obligations are complied with:
“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.”
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’).
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.