Medical Device Distribution in the UK

JoCam

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#1
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
 
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chris1price

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#2
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

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#3
Thank you chris1price,

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

Jo
 
#5
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.
 

dgrainger

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#7
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.
 
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