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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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Obelis UK is certified according to the international standards ISO 9001:2015 and ISO 13485:2016 for representative and consulting services.
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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