Responsible Person - WDA License

[Matt.mv]

Hi All,

I represent a company (a distributor based in the UK, with a parent organisation in Switzerland) that needs to change it's WDA License (for the UK based distributor), specifically the responsible person (RP). We have a low number of Class 1 MDD products at the moment (orthodontic wax style products, similar to dental floss).

From what I've found from online research into this, there is a some helpful guidance from the MHRA and a gold standard to give an overview of the requirements for an RP.

https://cogentskills.com/wp-content/uploads/2022/09/Responsible-Person-Medicinal-Products.pdf

Regulating medical devices in the UK

I am wondering if there are any specific Pros/Cons for the RP being myself based in the UK, or someone at the parent organisation?

From what I can see, I meet the criteria stated on the Cognent Gold Standards link, and I've already made a start on this throught MHRA portal.

If anyone is able to point me in the right direction, or provide me with any further information on this, I'd really appreciate it

EDIT: if it makes any difference, the medical devices are made by an outsourced manufacturer, allocated by the parent company in Switzerland.

 

[EricHeyworth]

The terminology really makes things tricky. The RP course you are talking about is for medicines not medical devices. The green guide (MHRA) covers medicines, but there is no direct equivalent for medical devices. If you devices are sold in GB only then you need to read the Medical Device Regulations 2005, if you need to sell also in the EU then also read the MDR 2017/745. Both documents define the equivalent to the RP (PRRC - Person Responsible for Regulatory Compliance). If you need more (FOC) help just message me. All the best, Eric

 

[EricHeyworth]

The terminology really makes things tricky. The RP course you are talking about is for medicines not medical devices. The green guide (MHRA) covers medicines, but there is no direct equivalent for medical devices. If you devices are sold in GB only then you need to read the Medical Device Regulations 2002, if you need to sell also in the EU then also read the MDR 2017/745. Both documents define the equivalent to the RP (PRRC - Person Responsible for Regulatory Compliance). If you need more (FOC) help just message me. All the best, Eric