Entering the European Market under the EU MDR is no longer about meeting isolation requirements. However, it is considered one of the most tedious tasks. This is due to the lack of technical understanding, and more objective considerations. It is at this time we would like to decipher for you, where you stand and how to take steps further.
We have seen repeatedly that it is not the manufacturers who believe they are already compliant that move forward with confidence but those who can demonstrate readiness across quality, clinical, and regulatory dimensions in a coherent and defensible way. We have designed a gap assessment worksheet that suffices as a Single Stop Window to assess your MDR Current Readiness
The checklist systematically maps each applicable MDR requirement to corresponding sections of the technical documentation, ensuring clear traceability, consistency, and completeness across the entire medical device lifecycle. It covers key elements including medical device description, design and manufacturing information, risk management, design verification and validation activities, clinical evaluation, and post-market surveillance.
The table below presents a preview of the EU MDR Technical Documentation Compliance Checklist and Guidelines:
Overview of the Gap Assessment Template: MDR Technical Documentation (EU MDR 2017/745)
Checklist Guide for Reference
As inputs are entered by the medical device manufacturer into SJML’s exhaustive EU MDR Gap Assessment checklist, the dashboard will provide an overall evaluation of technical documentation efficiency and readiness through compliance scoring. The dashboard offers a consolidated view of conformity against Annex I (GSPR), Annex II, and Annex III, enabling an objective assessment of documentation completeness, traceability, and submission readiness.
Compliance status will be visualized by the MedTech manufacturer through a colour-coded scoring system:
- Green (Compliant): requirement fully addressed with objective evidence
- Amber (Partially Compliant): requirement addressed but requiring clarification, some incomplete or required updates
- Red (Non-Compliant): requirement not met or evidence missing, representing a potential Notified Body finding.
- Blue: Aggregate percentage score reflecting overall compliance status
Start Your MDR Readiness Check Today! SJML’s exhaustive EU MDR Gap Assessment checklist version is available upon request on the website of Syrma Johari MedTech Ltd.
