GAP Assessment Technical Documentation Annex II & III
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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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Table of Content
SECTION 1: DEVICE DESCRIPTION AND SPECIFICATION 2
1.1 Device Description and Specification (including Variants & Accessories)
1.2 Device References
SECTION 2: INFORMATION SUPPLIED
SECTION 3: DESIGN AND MANUFACTURING INFORMATION
SECTION 4: GENERAL SAFETY AND PERFORMANCE REQUIREMENTS
SECTION 5: BENEFIT-RISK ANALYSIS AND RISK MANAGEMENT
SECTION 6: PRODUCT VERIFICATION AND VALIDATION 5
6.1 Pre-Clinical and Clinical Data
6.2 Additional Information
SECTION 1: POST-MARKET SURVEILLANCE PLAN
SECTION 2: PERIODIC SAFETY UPDATE REPORT & POST-MARKET SURVEILLANCE REPORT
Number of Pages