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MDCG 2019-07 Rev.1 (PRRC)

Medical devices regulation

🎄MDCG 2019-07 Rev.1 Guidance on Article 15 of the medical device regulation (MDR) and in vitro diagnostic device regulation (IVDR) on a ‘person responsible for regulatory compliance’ (PRRC) December 2023

A new revision has been issued today! That’s definitely Christmas. 🎄

More than a revision, it is nearly a brand new document.

Key updates in its December 2023 revision:

  • General Document Structure: Sections were reordered to align with the numbering of Article 15 MDR/IVDR paragraphs. The reference to 'in vitro diagnostic medical devices' was added throughout the document​​.
  • Clarifications and Additions:
    • A new section was added in the introduction.
    • Clarifications on qualifications, including new text on the 'course of study' and a minor amendment regarding qualifications acquired outside the EU.
    • Professional experience requirements were expanded with a new sentence and paragraph​​.
  • Authorized Representatives:
    • New sections were added, including clarifications on qualifications.
    • A new section on custom-made devices was introduced.
    • Additional details were provided on the meaning of “permanently and continuously at their disposal” for the PRRC (Person Responsible for Regulatory Compliance).
    • The document addressed the roles and responsibilities of the PRRC of an authorized representative and entities assuming the obligations of a manufacturer.
    • Information on the registration of the PRRC in Eudamed was updated​​.
  • Micro and Small Manufacturers:
    • A new sub-section was added for custom-made devices.
    • Changes were made to the PRRC location section, including the deletion of the first five words.
    • New footnotes (3, 4, 5, 6, and 8) were added.
    • The document clarified the availability requirements for the PRRC in the context of micro and small manufacturers​​.

What’s inside ?

  • Qualifications of PRRC: Manufacturers must have a PRRC with appropriate expertise, demonstrated through formal qualifications or professional experience.
  • Roles and Responsibilities: The PRRC's responsibilities include ensuring device conformity, maintaining technical documentation, complying with post-market surveillance obligations, and fulfilling reporting requirements.
  • Specific Conditions for Micro and Small Manufacturers: They are not required to have a PRRC within their organization but must have access to one.
  • Location of PRRC: The document discusses the location requirements for PRRCs, especially in relation to manufacturers outside the EU.
  • Responsibilities of Authorized Representatives: They must also have a PRRC, with similar qualifications and responsibilities.

Enjoy 💕

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