What certification is Required to Sell medical devices in the UK

J1980b

Starting to get Involved
#1
Hi,

Our company manufacture and sell medical devices, we are fully certified to ISO 13485, ISO 9001 and hold CE marking facilites

We have been approched by a company to design and develop a product. We would be the manufacturers and the product would be added to our 93/42/EEC Scope. The finished product would then be sold to and subsequently sold and distributed by the company who originally approached us.

Does this company need any certification ie ISO 9001 or ISO 13485? they would by named on the packaging as distributors, and ourselves as manufacturers.

Regards

J1980b
 
Last edited:
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somashekar

Staff member
Super Moderator
#2
Your distributor needs no certification. You are the legal manufacturer. You hold the CE and your product Ref appeares on the label.
 
B

Burgmeister

#3
Your contract with them will need to define Incident monitoring responsibilities and traceability responsibilities. You will be responsible for any recalls required so your distributor will need to show they are on top of traceability. It would make sense to make someone in your distributors company the Incident Monitor for the UK and you will need to show that they know what this entails.

Edit: Actually just noticed that you are located in the UK, so the IM part is not so important. Still need to be able to control distribution wrt traceability though.
 
R

rclanzillotto

#4
Hi Run the introduction of this new product past your Notified body (except for Class 1 devices) to make sure you are covered
 
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