The technical documentation of medical devices will also change under the MDR. Take the opportunity to critically review and carefully revise the file at an early stage.
The amended classification rules lead for some medical devices to a higher classification in the medical device class. As a result, for certain products that previously did not require an assessment by the Notified Body, the Notified Body has now to be involved for CE certification. Archiving deadlines have changed in part and the conformity assessment procedure itself contains changes. Not to forget that in future the original manufacturer will have to provide the private label manufacturer and representatives with the technical documentation for the products. The preparation is a very individual process, dependent on your products and the company constellation to possible original manufacturers or private label manufacturers.
Gain time and change over early. We support you:
- Review of your existing technical documentation.
- Gap analysis and determination of your individual requirements for the change to the requirements of the MDR.
- Revision of the technical documentation.
- Preparation of your individual implementation plan.
- Support during the implementation phase.
- Communication to the Notified Body.
Documentation in English language, optionally in German language.