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?
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