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:
- MDR: class III and class IIb implantable devices* (*acc. to MDR Art. 52 (4) second paragraph)
- IVDR: class B, C, and D devices and batch verification applicable to class D devices
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.
WHY DOWNLOAD THE MDR GUIDANCE DOCUMENT?
- It is a proposal for your summary of TD which can be directly completed by your company.
- It refers to the documents/records required by MDR annex II and III, so you won't have to do unnecessary work.
- It gives a clear and structured oversight regarding the medical device description for 3rd parties.
- This supports an efficient and timely assessment of your submitted TD at TÜV SÜD premises.
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
