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Technical documentation

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

What do you need to ensure?

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

How can Obelis 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.

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Our regulatory affairs consultants are committed to deliver the most efficient compliance process and support manufacturers to safely place their products on the UK market.
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