GAP Assessment Technical Documentation Annex II & III

Are you ready for the EU MDR?
 
We support you to easily implement the new Medical Device Regulation 2017/745. 
 
What is a GAP Assessment Template? 
 
This template enables you to systematically examine your medical device’s Technical Documentation to determine whether it demonstrates conformity with all relevant MDR 2017/745 requirements defined in Annex II and Annex III.
 
 
Why do you need it? 
 
In 2017, the European Union Medical Device Regulation 2017/745 (EU MDR) was published as a reliable, transparent and sustainable regulatory framework for medical device manufacturers. Thus, it replaces the Medical Device Directive. Since May 26, 2021, the extended transition from MDD to MDR has ended and compliance with the requirements of the EU MDR is mandatory. After May 26, 2025, devices certified under MDD can no longer be sold or distributed. As a manufacturer it is your responsibility to create and maintain a Technical Documentation with the content defined in Annex II and III of the MDR.
 
By using our template you can easily check conformity with all requirements set out in Annex II and III of the MDR. 
 
How to use it? 
 
Buy the template and download it straight away. 
Use the tables to systematically examine your medical device’s Technical Documentation to determine whether it demonstrates conformity with all relevant MDR 2017/745 requirements defined in Annex II and Annex III.
 
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