Quick question on responsible person's experience requirements

[Jonathanlai928]

Hi there, there is an opportunity for me to be trained as a Responsible Person as our company desperately needs one since the old one left and the most obvious candidate had a conflict of interest as explained by MHRA. We only deal with Chloraprep so risk is pretty low whether that makes a difference I don't know but this is my question:

I'm relatively young in terms of age and experience. I would have maybe 8 months of medicinal product distribution experience and I have a medical background in terms of education as well as a master's degree but that's it. My company is willing to sponsor the gold standard course for RP but I was wondering realistically what are my chances of being accepted by the MHRA? I don't meet the 1 year requirement/recommendation as I am not a pharmacist by trade.

 

[indubioush]

Just find a consultant that you can reach out to if needed.

 

[twanmul]

I'll assume that you're referring to Person Responsible for Regulatory Compliance as per MDR or IVDR rather than the UK Responsible Person and that the reference to the MHRA being involved in the suitability process means you're working out of Northern Ireland (and therefore MDR/IVDR apply there). If you're not based in Northern Ireland, then I can't see how the MHRA would have any say on the suitability of you being a PRRC under EU Regulations.
Being a PRRC for medical devices/IVD's isn't like an RP for GDP or like a QP for medical products. As such it isn't currently necessary to undertake a formal "course" or assessment for being a PRRC for medical devices/IVD's needed in order to fulfill the criteria set out in Article 15 of MDR & IVDR.
Having said this, if you have less than a year of experience in QA/RA for medical devices, then you don't meet the criteria (if you have a medical qualification then you do meet the criteria for the qualification as this is covered by qualifications in "law, medicine, pharmacy, engineering or another relevant scientific discipline"). There are two options left for you:
i. See if you qualify as a micro or small enterprise, in which case you wouldn't need a PRRC (Article 15, Subsection 2) , or;
ii. Contract out for 4 months, listing joint responsibility between you and the contract PRRC (as per Article 15, Subsection 4) until you have 12 months experience - at which point you can then remove the contractor and have you as the sole PRRC.

 

[dgrainger]

For GB, "The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020"[1] substitutes UK RP for Authorised Rep into what was the MDD based regulations, so there aren't any qualification requirement!

If you're in NI, then the EUMDR & "The Medical Devices (Northern Ireland Protocol) Regulations 2021"[2] apply, and, as stated above, there is a experience requirement for the PRRC.

You can ask MHRA as they are still the Competent authority - [email protected]


1 - The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020
2 - The Medical Devices (Northern Ireland Protocol) Regulations 2021