Informational EU – MDCG 2019-7 Guidance on Article 15 of the Medical Device Regulation (MDR) and in vitro Diagnostic Device Regulation (IVDR) regarding a “person re

[Marcelo]

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)

Posted at Marcelo's Medicaldevice.expert website...

You may comment and discuss in this discussion thread.

 

[Michael Ayers]

For manufacturers of custom-made devices, does this mean they can have a PRRC with either:

- a 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;

or

- at least two years of professional experience within a relevant field of manufacturing

Why would experience within a relevant field of manufacturing be able to replace experience in regulatory affairs or in quality management systems relating to medical devices?

 

[Marcelo]

For manufacturers of custom-made devices, does this mean they can have a PRRC with either:

- a 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;

or

- at least two years of professional experience within a relevant field of manufacturing

Why would experience within a relevant field of manufacturing be able to replace experience in regulatory affairs or in quality management systems relating to medical devices?

Because custom-made devices are specific made for a patient (and the device does not need to comply with several parts of the regulation because of this), so the main concern is that the "responsible person" knows how to manufacture the device.

 

[Susan]

Thanks for the information.
I have a question that how to interpret the following requirement in this guidance?
For a manufactures outside the EU, how to make the university diplomas or certificates be recognized by an EU Member State ?

Could anyone please give your opinion? Thank you in advance.

Clarification on qualifications
It shall be noted that:
- For the purpose of fulfilling the requirement laid down in point “a” of Article 15 (1), any qualification acquired outside the EU, including any university diplomas or certificates, should have been recognised by an EU Member State as equivalent to the EU corresponding qualification."

 

[Marcelo]

Thanks for the information.
I have a question that how to interpret the following requirement in this guidance?
For a manufactures outside the EU, how to make the university diplomas or certificates be recognized by an EU Member State ?

Could anyone please give your opinion? Thank you in advance.

You have to verify how this is done in the country you with to be verified with. All countries usually have a specific procedure for recognition.

 

[Susan]

You have to verify how this is done in the country you with to be verified with. All countries usually have a specific procedure for recognition.

Understood.
Thank you for your reply!

 

[jayakrish]

Hi,
I need clarification on one of the requirement of this guideline on subcontracting authorized representative:
- suppose Authorized representative is subcontracted to Third party or an agency, do the contract agreement should capture the qualification details of "third party personnel" responsible for regulatory compliance .

Thank you in advance

 

[Helen_H]

Hi,

I'd be glad if someone could give a clarification on the professional experience requirement:
Professional experience in regulatory affairs or in quality management systems relating to medical devices should be related to the EU requirements in the field.
Where are these requirements? Does it mean that except for diploma recognition, PRRS's professional experience shall be also recognized?

Thank you in advance for your opinion!