Is the Technical File still a requirement?

In MDR there is a requirement for Technical documentation. It is covered in Annex 2 - Technical documentation and Annex 3 - Technical documentation on post-market surveillance.

For more details, please see:

• EU MDR Annex 2 – Technical documentation - https://advisera.com/13485academy/mdr/technical-documentation/
• EU MDR Annex 3 – Technical  documentation on post-market surveillance - https://advisera.com/13485academy/mdr/technical-documentation-on-post-market-surveillance/

In Our ISO 13485:2016&MDR Integrated toolkit we have prepared the following procedures and templates:

• Technical file procedure https://advisera.com/13485academy/documentation/technical-file-procedure/
• Technical documentation checklist https://advisera.com/13485academy/documentation/technical-documentation-checklist/

Additionally, we have prepared the following procedures and associated templates, required by MDR:

• Procedure for clinical evaluation - https://advisera.com/13485academy/documentation/procedure-for-clinical-evaluation/
• Procedure for Post-Market Surveillance System - https://advisera.com/13485academy/documentation/procedure-for-post-market-surveilance/