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.

You might also be interested in

→ Technical Documentation in detail

→ Extra requirements in Technical Documentation

→ UK Registration for Medical Devices & In-Vitro Diagnostics

→ The UKCA

→ UK Responsible Person for Medical Devices & IVDs

Appoint Obelis UK Ltd. as your UK RP today.

Appoint Obelis UK LTD. as your UK RP