Register as a Manufacturer to Sell Medical Devices- Guideline Updates

If you place certain medical devices on the EU market then you or your authorised representative (agent) must be registered with the competent authority (national health regulator) in the EU state where you have an office or place of business.

In the UK, Medicines and Healthcare Products Agency (MHRA) is the competent authority for the registration of medical devices. The MHRA will only register manufacturers or authorised representatives that have a place of business in the UK.

You must register a manufacturer or authorised representative (agent) for a manufacturer, to sell medical devices, including in vitro diagnostic (IVD) medical devices.

To read more about registering as a manufacturer to sell devices please click here.

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Published on 23. February 2016 in News UK