How to Build an MDR Technical File

Step 1: Define the device and its intended purpose

Write the intended purpose, intended users, patient population, indications and contraindications, and principles of operation. List variants, configurations and accessories. This text feeds Annex II Section 1, the IFU, the risk analysis and the clinical evaluation plan. Ambiguity here becomes inconsistency everywhere else.

Step 2: Classify and choose the conformity assessment route

Apply the Annex VIII rules and document which rule applies and why, using MDCG 2021-24 for interpretation. If several rules apply, the strictest one governs. The class determines whether you need a notified body and which Annex IX to XI route applies.

Step 3: Plan risk management

Write the risk management plan with acceptability criteria before the analysis. Start the hazard analysis from the intended use and reasonably foreseeable misuse.

Step 4: Work through the GSPR checklist

Decide applicability for every Annex I requirement, define the method and standards, and note which evidence is needed. The checklist becomes the test plan for verification.

Step 5: Collect verification and validation evidence

Link each report to the GSPR rows and risk controls it supports, and check the verdict before linking.

• Biocompatibility according to the ISO 10993 series for body-contacting materials
• Sterilisation validation and packaging validation for sterile devices
• Electrical safety and EMC for active devices
• Software lifecycle and validation for devices with software
• Usability engineering
• Stability and shelf life

Step 6: Clinical evaluation

Write the clinical evaluation plan, identify and appraise data, and document the result in the CER. Decide whether PMCF is needed and write the PMCF plan or the justification.

Step 7: Labelling and IFU

Draft the label and IFU against Annex I Section 23 and check that warnings and residual risks match the risk management file and that claims match the CER.

Step 8: Post-market surveillance documentation

Write the device-specific PMS plan with indicators and thresholds and set the PSUR or PMS report schedule for the class.

Step 9: Consistency review

• Intended purpose identical across description, IFU, CER and risk file
• Every applicable GSPR has evidence
• Every risk control has verification evidence
• Every IFU claim is supported in the CER
• PMS plan indicators relate to the risks and clinical claims

How MDRpilot supports this sequence

MDRpilot follows the same order: the product record holds the description and the Annex VIII rationale, the GSPR and risk modules work on the same data, evidence is linked with confirmation, the clinical and PMS modules build on the device description, and the readiness view lists what is still missing before export.