Medical Software CE Marking Technical Documentation Guide
Navigating medical software CE marking demands meticulous technical documentation that satisfies EU MDR (Regulation 2017/745) requirements. Software manufacturers face unique challenges, as their products must comply not only with MDR but also with IEC 62304 for software lifecycle processes, IEC 62366 for usability engineering, and IEC 82304-1 for health software safety.
Technical documentation must demonstrate software classification rationale, risk management per ISO 14971, cybersecurity measures, and clinical evaluation evidence all tailored to the software’s intended purpose and risk class. This guide breaks down the essential documentation components manufacturers need to build a compliant, audit-ready technical file for successful CE marking approval.
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Medical Software CE Marking
Scope of Consultants and Developer
| Phase 1 Software Medical Device Introduction | ||||
|---|---|---|---|---|
| Annex II Clause | Sec. No. | Description | Scope of I3CGlobal | Scope of Client |
| 0 | I | INTRODUCTION | Provide the overview and structure of the technical file as per the MDR Annex II framework. Define scope of technical documentation |
Review and confirm the scope of technical documentation. |
| 0 | 1 | TECHNICAL FILE DETAILS | Frame the technical documentation file (TDF). Set up the cloud folder structure and share it with all stakeholders. |
Provide internal document control and record control numbers as per EN ISO 13485 procedures. |
| 0 | 1.1 | REVISION HISTORY | Prepare and maintain the TDF revision history template; log changes at every review cycle / update as applicable (Until granting CE) | Inform I3CGlobal of any device or changes requiring a new revision entry. |
| 0 | 1.2 | WARNING | Insert the standard confidentiality/proprietary information notice as per company practice. | Confirm the confidentiality classification of the technical file as per EN ISO 13485 / GMP procedure. |
| 0 | 1.3 | TECHNICAL FILE | Compile and format the complete technical documentation file (TDF) as per MDR Annex II (both Part A and Part B annexures / supporting evidence). | Provide all device-specific source documents and data required for compilation wherever applicable and as per your availability. |
| 0 | 1.4 | PURPOSE | Draft the purpose statement of the TDF with reference to MDR 2017/745. | Review and approve the purpose statement. |
| 0 | 1.5 | SCOPE | Define the scope of the technical file, covering the device models/variants under review. | Confirm the exact models, variants and accessories to be included in the scope. |
| 0 | 1.6 | COMPANY PROFILE | Review and update in TDF | Provide company profile details history, facilities, and certifications held. |
| 0 | 1.7 | LEGAL NAMES AND ADDRESS OF THE MANUFACTURER | Verify the manufacturer name and full manufacturing location address against any legal address proof issued by a government / central / state agency. Review the corporate office address if applicable and to be printed on the CE certificate. |
Provide the manufacturer's name and registered address with supporting evidence. Provide contact information with the name of the person, designation and email. |
| 0 | 1.8 | EUROPEAN UNION AUTHORIZED REPRESENTATIVE | Review EAR agreement, mandate and EAR SRN details along with PRRC. | Confirm the appointment of the EU Authorized Representative and provide the mandate, agreement and SRN |
| 0 | 1.9 | NOTIFIED BODY | Provide guidance on Notified Body selection and prepare the section referencing NB details. Submit applications with multiple NBs if not applied |
Provide the notified body name, identification number and certificate details (if already engaged). |
| Phase 2 Software Device Description and Specification, Including Variants and Accessories / Components / Modules | ||||
| 1 | 1 | DEVICE DESCRIPTION AND SPECIFICATION INCLUDING VARIANTS & ACCESSORIES | ||
| 1.1 | 1.1 | DEVICE DESCRIPTION AND SPECIFICATION | ||
| 1.1a | 1.1.1 | PRODUCT OR TRADE NAME | Format and insert the product/trade name in the document. | Provide the confirmed product/trade name(s). |
| 1.1a | 1.1.2 | GENERAL DESCRIPTION | Draft the general description based on inputs, ensuring MDR-compliant language. Compile the device description section from the data supplied. Compile the description of each module, interfaces and interoperability between each module at a high-level as provided per MDR requirements. Review its consistency with the labelling |
Provide the technical write-up about the device. Provide description of each module, interfaces and interoperability between each module at a high-level Information regarding the deployment as SW application or web accessible SW device Prerequisites for functioning of SW (Hardware, OS compatibility, Drivers, Processors etc.) |
| 1.1a | 1.1.3 | INTENDED PURPOSE | Review and refine the intended purpose statement for MDR compliance. Review its consistency with the labelling |
Provide the intended purpose STATEMENT of the device. |
| 1.1a | 1.1.4 | INTENDED USERS | Format the intended user profile section. Review the intended users based on the intended clinical use and clinical data Review its consistency with the labelling |
Identify the intended user group(s) (e.g., healthcare professional, layperson). |
| 1.1b | 1.1.5 | BASIC UDI-DI | Guide on basic UDI-DI generation and verify or validate the format the Issuing agency’s guideline Review its consistency with the labelling |
Generate and provide the basic UDI-DI via the assigned issuing agency. |
| 1.1c | 1.1.6 | THE INTENDED PATIENT POPULATION | Review the intended patient population based on the intended clinical use and clinical data Review its consistency with the labelling |
Provide the intended patient population details. |
| 1.1c | 1.1.7 | MEDICAL CONDITIONS | Review the medical conditions based on the intended clinical use and clinical data Review its consistency with the labelling |
Provide the medical condition(s) the device is intended to treat, diagnose or monitor. |
| 1.1c | 1.1.8 | INDICATIONS | Draft the section format and cross-check consistency with labelling. Review the medical indications on the intended clinical use and clinical data Review its consistency with the labelling |
Provide the indications for use. |
| 1.1c | 1.1.9 | CONTRA-INDICATIONS | Draft the contraindications based on the labelling requirements from Risk and Clinical Evaluation | Provide contraindications, if any. Confirm the listed contraindications |
| 1.1c | 1.1.10 | WARNINGS | Cross-check warnings against GSPR and labelling requirements from Risk and Clinical Evaluation | Provide the list of warnings/precautions associated with device use. |
| 1.1d | 1.1.11 | PRINCIPLE OF OPERATION | Draft/review the principle of operation description for regulatory clarity. | Provide the technical explanation of how the device works (mechanism of action). |
| 1.1e | 1.1.12 | MEDICAL DEVICE RATIONALE | Draft the rationale for qualifying the product as a medical device under MDR Article 2 or MDCG 2019-11 | Provide supporting technical/clinical rationale and intended medical purpose evidence. |
| 1.1f | 1.1.13 | DEVICE CLASSIFICATION AND JUSTIFICATION | Perform device classification per MDR Annex VIII and prepare the classification justification/rationale document or per MDCG 2021-24, Rev.1 and software safety classification per IEC 62304 | Provide the details required for classification and review/approve the classification. |
| 1.1g | 1.1.14 | EXPLANATION OF NOVEL FEATURES | Draft the section highlighting novel features/algorithms, AL/ML features being included in the SW, versus previous/prior generation versions | Identify and describe the novel features /algorithms, AL/ML features being included in the SW, versus previous/prior-generation versions |
| 1.1h | 1.1.15 | DESCRIPTION OF THE ACCESSORIES | Not applicable | Not applicable |
| 1.1i | 1.1.16 | DESCRIPTION OF THE VARIANTS | Send a requisition to the client for modules, versions or configurations, if applicable covered in the scope of TDF and prepare the consolidated section as per MDR Annex II, Section 1. | Provide complete details of the modules, versions or configurations, if applicable |
| 1.1j | 1.1.17 | COMPONENTS DESCRIPTION WITH DRAWINGS | Compile the component description section and insert drawings/diagrams in the required format. Review the architecture diagram and refine according to MDR & IEC 62304 requirements and/or EU AI Act |
Provide engineering drawings, exploded views and component descriptions. Provide the architecture diagram along with SOUP items & configuration components |
| 1.1k | 1.1.18 | DESCRIPTION OF THE RAW MATERIALS | Review the SWBOM | Provide the SW bill of materials (SWBOM with its device lifetime EoD for SW) |
| 1.1l | 1.1.19 | TECHNICAL SPECIFICATIONS | Compile and review the technical specification tables/section. | Provide detailed technical specifications (OS, Driver, Platform, Cloud traffic, Load, Repeatability, Reliability etc |
| 1.2 | 1.2 | REFERENCE TO PREVIOUS AND SIMILAR GENERATIONS OF THE DEVICE | ||
| 1.2a | 1.2.1 | AN OVERVIEW OF THE PREVIOUS GENERATION | Review the previous versions provided | Provide previous released versions in the market |
| 1.2b | 1.2.2 | AN OVERVIEW OF EQUIVALENT OR SIMILAR DEVICES | Assist in identifying equivalent and similar SW devices and list it and do comparisons based on high-level technical specifications. | Provide technical and clinical information of the equivalent/similar SW device (if the equivalence route is pursued). |
| Phase 3 Information to be Supplied by the Software Developer / Manufacturer | ||||
| 2 | 2 | INFORMATION TO BE SUPPLIED BY THE MANUFACTURER | ||
| 2 | 2.1 | LABELS | Review label content/symbols against MDR labelling requirements (Annex I, 23.123.4) and ISO 15223-1 symbols; provide corrections. | Provide the content of all device labels and its deployment information |
| 2 | 2.2 | IFU | Review IFU content against MDR Annex I check requirements, risk, clinical and applicable standards and provide corrections. | Provide the draft Instructions for Use in all required languages. |
| Phase 4 Software Design and Development Information | ||||
| 3 | 3 | DESIGN AND MANUFACTURING INFORMATION | ||
| 3a | 3.1 | DESCRIPTION OF THE DESIGN | Compile and review the SW architecture design description/design controls summary and SW development Plan | Provide SW architecture design file extracts/design description as per IEC 62304 requirements. Provide SW development plan |
| 3b | 3.2 | DESCRIPTION OF THE MANUFACTURING PROCESS | ||
| 3b | 3.2.1 | MANUFACTURING PROCESSES | Review the SW development methodology shared | Provide the SW development lifecycle methodology used for the development of SW, and its description methodology |
| 3b | 3.2.2 | FINAL PRODUCT SPECIFICATION AND TESTING | Compile the final product release specification and testing section. Compile /review the UAT reports, SW release notes |
Provide final product/release specifications and QC test records. Provide the UAT reports, SW release notes |
| 3b | 3.2.3 | MANUFACTURING ENVIRONMENTAL CONTROLS | Format the SW development controls infrastructure section and cross-check against applicable standards. | Provide details of SW development controls infrastructure & secured IT controls |
| 3c | 3.3 | SUPPLIERS AND SUBCONTRACTORS | Review the SWBOM and list the suppliers and subcontractors | Provide the list of critical suppliers/subcontractors, their roles and certificates (e.g., ISO 13485). Provide SWBOM |
| Phase 5 General Safety and Performance Requirements (GSPR) | ||||
| 4 | 4 | GENERAL SAFETY AND PERFORMANCE REQUIREMENTS | ||
| 4 | 4.1 | THE GENERAL SAFETY AND PERFORMANCE REQUIREMENTS | Complete the GSPR checklist, referencing supporting evidence/documents, and identify gaps. | Provide test reports, standards compliance data and technical justifications for each GSPR. |
| 4 | 4.2 | DECLARATION OF CONFORMITY | Prepare the Declaration of Conformity as per MDR Annex IV. | Review and sign the Declaration of Conformity. |
| 4c, 4d | 4.3 | LIST OF APPLICABLE LEGISLATION | Identify and compile the list of applicable EU legislation | Confirm any additional national/regional legislation applicable to the device. |
| 4c, 4d | 4.4 | LIST OF APPLICABLE GUIDELINES | Identify and compile applicable MDCG guidance documents. | Review and confirm the applicability of the listed guidelines. |
| 4c, 4d | 4.5 | LIST OF APPLICABLE HARMONIZED STANDARDS | Identify applicable harmonized standards (per the EU Official Journal) and compile the list. | Confirm standards tested against and provide certificates of compliance. |
| 4c, 4d | 4.6 | LIST OF APPLICABLE NON-HARMONIZED STANDARDS | Identify relevant non-harmonized / state-of-the-art standards applicable to the device. | Confirm any additional standards followed and provide supporting test reports. |
| Phase 6 Software Benefit-Risk Analysis and Risk Management | ||||
| 5a | 5.1 | THE BENEFIT-RISK ANALYSIS | Prepare/review the benefit-risk analysis and methodology as per Annex I, Chapter I. | Provide clinical/technical data supporting the benefit-risk determination. |
| 5b | 5.2 | RISK MANAGEMENT | Review the risk management file against ISO 14971, ISO/IEC 27001 and IEC 62304 and MDCG 2019-16 and MDR requirements; identify gaps and provide corrective guidance. | Conduct the risk management activities and provide the complete risk management file (plan, analysis, evaluation, control, and report). |
| Phase 7 Software Verification and Validation | ||||
| 6.1 | 6.1 | PRE-CLINICAL AND CLINICAL DATA | ||
| 6.1a | 6.1.1 | PRE-CLINICAL SAFETY | Review VAPT reports for completeness against the GSPR. | Provide Vulnerability Assessment & Penetration Testing (VAPT) |
| 6.1b | 6.1.2 | BIOCOMPATIBILITY OF THE DEVICE | Not Applicable | Not Applicable |
| 6.1b | 6.1.3 | ELECTRICAL SAFETY AND ELECTROMAGNETIC COMPATIBILITY | Not Applicable. | Not Applicable |
| 6.1b | 6.1.4 | SOFTWARE VERIFICATION AND VALIDATION | Review software V&V documentation against IEC 62304 and MDR requirements; provide gap analysis. | Provide software development lifecycle documentation, verification/validation test plan & reports and the software safety & security risk management file. |
| 6.1b, 6.2e | 6.1.5 | STERILIZATION | Not Applicable. | Not Applicable |
| 6.1b | 6.1.6 | STABILITY | Not Applicable. | Not Applicable |
| 6.1c | 6.1.7 | CLINICAL EVALUATION | Prepare/review the Clinical Evaluation Report (CER) as per MEDDEV 2.7/1 Rev.4 and MDR and MDCG 2020-1 requirements. | Provide clinical data, literature search inputs and post-market clinical follow-up (PMCF) data as available. |
| 6.1d | 6.1.8 | POST-MARKET ACTIVITIES | Prepare/review the PMS plan, PMS report/PSUR and PMCF plan templates. | Provide post-market surveillance data, complaints, vigilance reports and PMCF data. |
| 6.1d, 6.2e | 6.1.9 | PACKAGING AND TRANSPORTATION | Not Applicable. | Not Applicable. |
| 6.2 | 6.2 | ADDITIONAL INFORMATION REQUIRED IN SPECIFIC CASES | ||
| 6.2a | 6.2.1 | MEDICINAL PRODUCTS WITHIN THE MEANING OF DIRECTIVE 2001/83/EC | Not Applicable. | Not Applicable |
| 6.2b | 6.2.2 | TISSUES OR CELLS OF ANIMAL ORIGIN | Not Applicable. | Not Applicable |
| 6.2c | 6.2.3 | DEVICES THAT ARE COMPOSED OF SUBSTANCES OR COMBINATIONS OF SUBSTANCES | Not Applicable. | Not Applicable |
| 6.2d | 6.2.4 | CMR OR ENDOCRINE-DISRUPTING ACTIVITY | Not Applicable. | Not Applicable. |
| 6.2e | 6.2.5 | STERILIZATION | Not Applicable. | Not Applicable |
| 6.2f | 6.2.6 | MEASURING FUNCTION | Partially Applicable - As a standalone SW, it will be evaluated or tested under SW verification & validation. Review the accuracy/metrological verification data. |
Provide accuracy/metrological verification data. |
| 6.2g | 6.2.7 | COMBINATION WITH OTHER DEVICES | Partially Applicable: As a standalone SW the interfaces connected to any other SW will be evaluated or tested under SW verification & validation. Review the list of interfaces. |
Provide details of SW interfaces available within MDSW |
| 0 | 6.2.8 | MANUFACTURER DECLARATION | Prepare the manufacturer declaration template for the specific-case section. | Review and sign the manufacturer declaration. |
| Phase 8 Conclusion and Approval | ||||
| 0 | III | CONCLUSION AND APPROVAL | Prepare the final review summary and compile the complete technical file for client approval. | Perform the final review and provide sign-off/approval of the technical documentation. |