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NHS exemption - Benefits versus expectations in UK NHS service

James

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#1
Hi all

I'm wondering about the benefits versus expectations in a UK NHS service (we are a small class 1 device manufacturer) when it comes to MHRA registration vs in-house exemption benefits. If we’re registered as a manufacturer and putting products on the market commercially it will definitely give us more manufacturing freedom and the potential to sell our in-house manufactured products to others, but I'm guessing that the downside may be an additional layer of complexity with the UDI process, CE marking and possibly further scrutiny / certification via a notified body (thats worst case scenario, I don’t think NB involvement is necessary for class 1??).

Any thoughts from anyone?

Many thanks

James
 
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