On July 1, 2019, the Medical Device Coordination Group (MDCG) published their guidance on Article 15 of the MDR and IVDR regarding the Person Responsible for Regulatory Compliance (PRRC). Article 15 lists the requirements in six paragraphs. To assist the reader, I'll summarize what the requirements are and provide suggestions on how a manufacturer can comply to them.
Paragraph (1)
The manufacturer shall appoint one or more person(s) to be the PRRC. The PRRC must meet the one following qualifications:
- Evidence of completing a degree in law, medicine, pharmacy, engineering or another relevant scientific discipline. At least one year of professional experience in RA or QMS relating to medical devices, or
- 4 years of professional experience in RA or QMS relating to medical device.
Note: for custom-made devices, the PRRC must have at least two years of professional experience in manufacturing.
MDCG 2019-7 clarified that the any qualification such as university diplomas or certificates must be equivalent to EU's. The guidance also provide clarification that for organizations with more than one legal manufacturer, each legal manufacturer would have its own PRRC.
My comments/suggestions regarding Paragraph (1):
When appointed someone to be the PRRC of the organization, I would recommend that:
(a) the appointment of the PRRC is assigned by someone in the executive level and that the the individual accepting the role duly noted his/her responsibilities as the PRRC. I recommend documenting this.
(b) the individual's job description be updated to include the roles and responsibilities as outlined in paragraph 3 of Article 15.
(c) the organization chart be updated to include some reference that the individual is the PRRC, and of course,
(d) the individual assigned as the PRRC meets the qualifications as outlined in paragraph 1.
Paragraph (2)
Micro and small enterprise companies (50 or fewer employees with annual balance sheet not exceeding EUR 10 million) can assign a third party to be the PRRC but that person must be permanently and continuously at their disposal.
MDCG 2019-7 recommended that if the external party is the PRRC, the manufacturer should establish a contract laying down the provisions to ensure that the individual is "permanently and continuously" available. The guidance recommends that the individual's qualification be mentioned in the contract. II believe that it's entirely up to the manufacturer on how they wish to document the PRRC's qualification and that it doesn't have to be in the contract.
Paragraph (3)
The PRRC shall at least be responsible for ensuring that:
(a) the conformity of the device is appropriately checked, in accordance with the QMS before a device is released.
(b) the Technical Documentation and EU DoC are drawn-up and kept up-to-date.
(c) the PMS obligations comply with Article 10(10) and Article 10(9) of the MDR and IVDR, respectively.
(d) Reporting obligations such as recording and reporting of incidents and FSCA comply with the MDR and IVDR.
(e) in case of investigational devices for performance evaluation, there is a signed statement in accordance to Annex XV (MDR) or Annex XIV (IVDR).
Paragraph (4)
If there are more than one PRRC, their respective areas of responsibility shall be stipulated in writing.
My comment/suggestion on Paragraphs 3 and 4.
For procedures regarding PMS, incident reporting, investigational devices for performance evaluation, and ensuring that the Technical Documentation and DoC are up-to-date should make some references as to the role of the PRRC.
Paragraph (5)
The PRRC shall suffer no disadvantage to the proper fulfillment of his or her duties.
Paragraph (6)
The Authorized Representative shall have its own PRRC.
My comment/suggestion on Paragraph 6
Make sure that this requirement is on your Quality Agreement with your Authorized Representative and that they do have someone qualified to be the PRRC.
Hope this summary in some way is helpful to you.
Notes about the author:
Alex Chang is a Regulatory Affairs consultant and founder of BioDesign Regulatory Services, LLC. Alex held several roles in the medical device, diagnostics, pharmaceuticals and biologics industries since 2000. Alex began his career in Regulatory Affairs in 2003 and has been very involved with the regulatory community ever since 2012 with RAPS. His consulting company, BioDesign Regulatory Services, LLC was established in 2018.