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This is a new valuable, comprehensive and important addition in the EU MDR compared with old EU MDD. Just like Pharmaceutical Regulations, now Medical Devices do also have a regulatory guidance on how to compile their Technical Files.
The Support of IMDRF was voluntary guide to build a guidance on the Summary Technical Documentation (STED) format. It was developed to drive more standardization of medical device regulatory submissions across different markets.
The EU MDR explains now the contents of Technical Documentation for each Medical Device which is a compilation of all aspects of device design, manufacture, installation and use applicable to the device. Reference detail is available in Annex II of the EU MDR.
 
Annexure III of the EU MDR provides the details of technical documents in post-market situation.