A “responsible person” in accordance with Article 15 of the Medical Device Regulation (MDR) also became mandatory with the implementation of the MDR. Minimum requirements for this “person responsible for regulatory compliance” are specified in this relevant article.
Further information can be found in a guideline from the Medical Device Coordination Group (MDGC) entitled “MDCG 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). This guidance has now been revised. The MDCG is made up of members from all EU Member States and a representative of the EU Commission.
The following is an overview of the changes:
- The structure of the entire document has been adapted to Article 15 of the MDR. References to in-vitro diagnostics have also been adapted throughout the document.
- The introduction is new and also refers to 2 footnotes (1 and 2) to clarify the term “Union Market” as well as with regard to customized medical devices.
- In the chapter “Manufacturer” a clarification has been made regarding the qualification of a “responsible person”. A completely new section has been added on the professional background and there is a new sub-chapter on customized medical devices.
- A sentence on the availability of the “responsible person” has been added to the chapter on micro and small manufacturers. Furthermore, two footnotes (9 and 10) have also been introduced, one on the phrase “outside the Union” and the other on medical devices placed on the market in conjunction with a notified body.
- In the chapter on the role and responsibility of the “responsible person”, two introductory sentences have been added. This chapter has been significantly expanded with reference to Article 15(3)(a),(c),(d) and with a concluding section. Footnote 11 on the topic of vigilance has also been added.
- The chapters relating to Article 15, paragraph 5 (“no disadvantages for the responsible person”) and to authorized representatives in paragraph 6 are completely new.
- Two new chapters have also been added, one on the role and responsibilities of a “responsible person” in the case of an authorized representative and the other on the registration of the “responsible person” in the Euda med database.
Takeaway:
The MDCG 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) has been doubled in length as a result of the revision.
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