Medical Device File

Yes, it is the same. In the ISO 13485:2016 requirement, 4.2.3 Medical device file is stated that an organization must establish the medical device file with the content not limited to the one that is described there. Also, requirement 4.1 states that the organization must be in compliance with all necessary regulatory requirements. 

On the EU market, it is not possible to put a medical device without having a technical file under the MDD 93/42/Eec or, from May 2021. according to the MDR 2017/745. 

For more information please see the following articles:

• How to determine regulatory requirements according to ISO 13485:2016 https://advisera.com/13485academy/knowledgebase/how-to-determine-regulatory-requirements-according-to-iso-13485/
• How can ISO 13485 help with MDR compliance? https://advisera.com/13485academy/blog/2020/03/09/how-can-iso-13485-help-with-mdr-compliance/
• How to use ISO 13485 to fulfill FDA regulatory classes for medical devices https://advisera.com/13485academy/blog/2017/09/14/how-to-use-iso-13485-to-fulfill-fda-regulatory-classes-for-medical-devices/