Every IVD placed on the GB market needs to have a technical documentation in place, in accordance with the UK MDR
You must register all IVDs with the MHRA.
If your product is listed in Part IV of the UK MDR 2002, Annex II or is a self-test device, you will need to contact a UK Approved Body.
What can Obelis UK, Ltd. assist you with?
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Some useful links:
→ See the different routes to conformity for IVDs in the guidance on the directive
→ The conformity route is different for devices manufactured in healthcare establishments, see the guidance on in-house manufacturer of devices for more information
→ IVDR – UK & Switzerland · MDlaw – Information platform on European medical device regulations