Technical Documentation

In-vitro Diagnostics

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?

  • Review of Technical Documentation
  • Registration
  • Approved Body selection services

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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

Appoint Obelis UK Ltd. as your UK RP today.

Appoint Obelis UK LTD. as your UK RP