# EU MDR Technical Documentation Readiness Assessment > Source: https://netray.co/tools/mdr-technical-documentation-readiness-assessment > Publisher: Netray (netray.co), AI and integration engineering for ERP and manufacturing systems. > Section: Free Tools ## Short answer A short self-assessment of how complete and current your technical documentation is against the structure of MDR Annexes II and III. ## Category compliance-legal ## Industry Medical Devices ## Region European Union ## Audience - Regulatory affairs - Quality manager - Design engineer ## Tool **Kind:** assessment **Questions:** #### Device description and specification (Annex II section 1) **Help:** Intended purpose, variants, accessories, principles of operation and configurations. **Options:** ##### Complete, current and approved **Score:** 10 ##### Mostly complete, minor updates pending **Score:** 7 ##### Partial, variants or accessories missing **Score:** 4 ##### Not started **Score:** 0 #### Information supplied by the manufacturer (labels and instructions for use) **Options:** ##### Labels and IFU final, languages complete, symbols checked **Score:** 10 ##### Final in the main language, translations pending **Score:** 7 ##### Draft only **Score:** 3 ##### Not started **Score:** 0 #### Design and manufacturing information (section 3) **Help:** Manufacturing processes, validation, sites and suppliers. **Options:** ##### Processes, sites and key suppliers fully described and validated **Score:** 10 ##### Described, validations in progress **Score:** 6 ##### Partial description **Score:** 3 ##### Not started **Score:** 0 #### General safety and performance requirements (GSPR) checklist **Help:** Each applicable requirement with the method of demonstrating conformity. **Options:** ##### Every GSPR addressed with evidence references and standards edition **Score:** 10 ##### Mostly addressed, some evidence gaps **Score:** 6 ##### Table drafted without evidence references **Score:** 3 ##### Not started **Score:** 0 #### Benefit-risk analysis and risk management file **Options:** ##### Current, linked to PMS and clinical data, approved **Score:** 10 ##### Current but not yet linked to post-market data **Score:** 7 ##### Out of date relative to the design **Score:** 3 ##### Not started **Score:** 0 #### Verification and validation evidence (bench, biocompatibility, software, electrical, sterilization, shelf life) **Options:** ##### All applicable reports complete and traceable to requirements **Score:** 10 ##### Most complete, one or two outstanding **Score:** 6 ##### Several reports missing **Score:** 3 ##### Not started **Score:** 0 #### Clinical evaluation report and clinical evidence plan **Options:** ##### Report current with literature search protocol and equivalence justified **Score:** 10 ##### Report drafted, awaiting update **Score:** 6 ##### Plan only **Score:** 3 ##### Not started **Score:** 0 #### Post-market surveillance plan, PMS report or PSUR (Annex III) **Options:** ##### Plan in place and reports prepared on schedule **Score:** 10 ##### Plan in place, first report not yet due **Score:** 7 ##### Plan drafted but not implemented **Score:** 3 ##### Not started **Score:** 0 #### Document control and traceability of the technical file itself **Options:** ##### Versioned, indexed, change controlled and linked to design changes **Score:** 10 ##### Indexed but changes not always reflected **Score:** 6 ##### Files in folders without an index **Score:** 3 ##### Ad hoc **Score:** 0 #### UDI, registration and declaration of conformity readiness **Options:** ##### UDI-DI assigned, EUDAMED data ready, declaration of conformity drafted **Score:** 10 ##### UDI-DI assigned, registration data in progress **Score:** 6 ##### UDI plan only **Score:** 3 ##### Not started **Score:** 0 **Bands:** #### Early stage **Min:** 0 **Max:** 39 **Verdict:** The technical file is far from submission-ready and significant structured work is needed. **Recommendations:** - Create the file index based on Annex II and III headings - Assign an owner for each section with dates - Confirm device classification and applicable standards first #### Developing **Min:** 40 **Max:** 64 **Verdict:** Core sections exist but evidence gaps and out-of-date content would likely draw questions. **Recommendations:** - Close GSPR evidence gaps before polishing documents - Update the risk file and benefit-risk analysis for the final design - Plan outstanding verification and validation reports #### Nearly ready **Min:** 65 **Max:** 84 **Verdict:** The file is mostly complete. Remaining items are specific and fixable. **Recommendations:** - Run an internal review as a notified body reviewer would - Check that traceability from requirements to evidence is intact - Align clinical and PMS documents with the final labeling #### Ready for review **Min:** 85 **Max:** 100 **Verdict:** The documentation appears complete. Maintain it under change control. **Recommendations:** - Set a review schedule tied to design changes and PMS outputs - Keep standards editions and regulatory guidance current - Prepare responses and an index for notified body questions ## Content **Intro:** Notified bodies and competent authorities expect technical documentation structured around Annexes II and III of the EU MDR. This ten question self-assessment shows where your file is strong and where evidence is thin. **Sections:** #### How to use it **Body:** Answer each question for one device family, with the regulatory lead and design owner in the room. Choose the option you can prove today from the controlled documents, not the one you expect to complete next month. The score and band summarize readiness and the recommendations highlight where to start. Export the result and repeat it quarterly while the file is being built. **Bullets:** - One device family per assessment - Score what exists in controlled form - Repeat quarterly and compare #### What Annex II and Annex III expect **Body:** Annex II describes the technical documentation: device description and specification, information supplied with the device, design and manufacturing information, the general safety and performance requirements checklist, benefit-risk and risk management, and product verification and validation including clinical evaluation. Annex III covers the technical documentation on post-market surveillance. The questions follow this structure so results map to sections you will submit. #### Reading your result **Body:** A low score on the GSPR or verification questions is the most serious because those sections carry the proof of conformity. A low score on document control matters more than it seems, since an unindexed file is hard to review and prone to inconsistent versions. Clinical evaluation is usually the longest lead item, so start early if it scores low. #### Common mistakes **Body:** Frequent problems include GSPR tables without references, risk files not updated after design changes, labeling that differs between the technical file and the packaging, clinical evaluation based on equivalence that cannot be justified, and PMS plans that exist but do not feed back into risk management. Keep the file connected to change control so every design change prompts a review. **Cta:** If your technical documentation depends on ERP data for suppliers, lots and changes, Netray can discuss ways to keep those references accurate. **Faq:** #### Is this a conformity assessment? **Answer:** No. It is a self-check to find gaps. Conformity assessment is performed according to the MDR route for your class, often with a notified body. #### Does it apply to legacy devices under transition? **Answer:** The structure applies, but transitional provisions and timelines have their own conditions. Check current EU transition rules for your certificates. #### Why is document control scored? **Answer:** Reviewers need a consistent, versioned file. If the file cannot be indexed and shown to be current, even good content is hard to defend during review. #### Can I use it for non-EU markets? **Answer:** Much of the content overlaps with other markets, but FDA, Health Canada and others have their own formats. Use it as a starting point and map to local requirements. ## Search terms mdr technical documentation checklist, mdr annex ii technical file, technical file readiness, mdr gspr checklist, mdr notified body technical documentation review, mdr annex iii post market documentation, technical documentation assessment medical device, mdr benefit risk file --- Talk to an engineer: https://netray.co/contact?intent=erp_ai | Machine catalog: https://netray.co/agent/catalog.json