Be confident of medical device market approval
Be confident of medical device market approval
In alignment with the requirements of the Regulation (EU) 2017/745 and Regulation (EU) 2017/746, it is required to submit the Technical Documentation (TD) together with the application starting from 15 May 2022. This applies for:
TDs for devices sampled on a representative basis will be requested by your Conformity Assessment Responsible (CARE) on an annual basis.
MDR Technical Documentation (TD) Checklist
To help you to compile a complete TD which supports an efficient and timely assessment, TÜV SÜD Medical Health Services created a guidance document: Summary of MDR TD.
However, if this document or parts thereof is not followed, it will still be possible to conduct a successful assessment of the TD. Please do not hesitate to contact your personal CARE if you have any questions.
Related Services & Documents: MDR Technical Documentation | Medical Device Regulation (MDR) | Medical Device Regulation Service Registration
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