Technical Documentation

Medical Devices

Manufacturers must keep technical documentation that demonstrates that their products conform to the requirements of the UK MDR.

What do you need to do?

  • The documentation must be prepared before drawing up the declaration of conformity;
  • Keep the documentation for a period ending at least 5 years after the last products have been manufactured;
  • Remember that the Competent Authority can ask to see the documentation at any time.

How can Obelis UK, Ltd. assist you?

Obelis UK as your Responsible Person will keep available a copy of the technical documentation, a copy of the declaration of conformity and, if applicable, a copy of the relevant certificate, including any amendments and supplements for inspection by the MHRA.

Appoint Obelis UK Ltd. as your UK RP today.

Appoint Obelis UK LTD. as your UK RP