Medical Device Distribution in the UK

[JoCam]

Hi All,

Does a company set up to distribute medical devices across the UK that they do not themselves manufacture need to register with the MHRA?

Jo

 

[chris1price]

As of today, I am not aware of any such requirement with regard to medical devices. If they act as a distributor, there will be requirements under the MDR.

If they distribute pharmaceuticals, then there are requirements.

 

[JoCam]

Thank you chris1price,

Do you know if the company has to register anywhere as a distributor if they wish to sell medical devices?

Jo

 

[chris1price]

Each country may have specific requirements, I think you'll have to look at it on a country-by-country basis.

 

[jham65]

Does anyone know if UK MHRA will be delaying its transition requirement for Class I devices due to MDR delay? I am receiving guidance that May 26, 2020 is still the MHRA deadline.

 

[chris1price]

At the time of writing, there is no MDR delay. The MDR will probably be postponed, but it hasn't happened yet.

 

[dgrainger]

Does anyone know if UK MHRA will be delaying its transition requirement for Class I devices due to MDR delay? I am receiving guidance that May 26, 2020 is still the MHRA deadline.

The UK should implement any postponement as required by the withdrawal agreement.