This article outlines the general set of documents that manufacturers are expected to submit in the technical documentation when applying for conformity assessment through Scarlet as a notified body. These documents support clinical, safety, and performance claims in accordance with EU MDR requirements.
⚠️ Important: This is not an exhaustive list. Requirements may vary depending on the type and classification of the device, specific regulatory pathway, applicable standards (e.g. software or AI components), and risk profile.
Device Information
These documents describe the device, its intended use, and basic technical data
Device description – Technical specifications and overview of the device design.
Intended purpose – Clearly outlines the intended medical purpose and patient population.
Label – Example of product labelling including required regulatory information.
CE marking evidence – Proof and rationale supporting CE mark placement.
Instructions for use (IFU) – Comprehensive user guidance for safe and effective use.
Declaration of conformity – Statement declaring conformity to applicable EU legislation.
Software
Use Requirement & Validation
These documents define the medical device’s use requirements and ensure that these requirements are met through the planning and execution of validation activities.
Use requirements – Defines a comprehensive set of requirements that the medical device must meet to ensure fitness for purpose, usability, and clinical safety, including software-specific requirements covering information security, installation, operation, maintenance, and decommissioning.
Validation plans – Defines planned validation activities, the validation personnel and any constraints of the validation activities.
Validation reports – Reports that detail the execution and outcomes of the planned validation activities.
Software and AI Model Development
These are required for devices incorporating software, including AI-driven features
Software development plans – Describes the strategies for software development, configuration management, verification, maintenance and problem resolution.
Software requirements – A comprehensive set of technical requirements that the medical device software must fulfil.
Software architecture & design – Defines the composition and safety classification of the software components in terms of software modules, interfaces, units and SOUP.
AI model design – Describes the training and inference of any models within the medical device software that are based on machine learning or deep learning techniques.
Software test specification and test reports – Documents the detailed test specifications within each software verification activity and the associated test execution reports.
Software verification summary report – Concludes the verification with a summary of the executions and outcomes.
Software release – Describes the software release.
Risk / Usability
Risk
Risk-related documentation demonstrates the proactive identification and control of hazards:
Risk management plan – Describes the risk management strategy throughout the product life cycle.
Risk records – Documents the safety/security characteristics of the medical device, use errors, hazards-related use scenarios and the possible risk sequences of hazards leading to hazardous situations and harms, including the risk estimation, evaluation, controls, and benefit-risk analyses.
Risk management report – Summary and conclusions of the risk management activities that are required for a technical submission.
Risk management process review – A record that persons with appropriate authority have reviewed the implementation and results of the risk management process.
Usability
Documents demonstrating human factors engineering and use-related risk mitigation:
User training - Describes any user training required to ensure the specified performance and safe use of the medical device.
Usability engineering formative evaluation plan – Strategy and activities for conducting formative usability engineering evaluation, if applicable.
Usability engineering summative evaluation plan – Strategy and activities for conducting formative usability engineering evaluation.
Usability engineering formative evaluation report – Results and interpretation of formative usability engineering activities, if applicable.
Usability engineering summative evaluation report – Results and interpretation of summative usability engineering activities, if applicable.
Clinical
These documents provide the foundation for demonstrating the clinical performance and safety of the device:
Case report form - Template for capturing individual patient data during clinical investigations.
Clinical evaluation plan - Outlines objectives, design, methodology, and analysis of the clinical study.
Clinical evaluation report - Comprehensive summary of the completed clinical investigation.
Clinical investigation analysis - A focused evaluation of data collected during a clinical investigation.
Clinical investigation application form - Used for applying to the competent authorities for study approval.
Clinical investigation plan - Outlines objectives, design, methodology, and analysis of the clinical study.
Clinical investigation report - Comprehensive summary of the completed clinical investigation.
Clinical investigators brochure - Provides comprehensive background and investigational device information to clinical investigators.
Equivalence claim template - Justification for clinical equivalence with another device, if applicable.
Literature Search Template - A literature search is a systematic process for identifying, reviewing, and analysing published and non-published data relevant to a medical device.
Post-market clinical follow-up (PCMF) plan - Strategy for ongoing clinical data collection post-market.
Summary of safety and clinical performance - Public-facing summary for implantable and class III devices.
Post market surveillance
These documents support ongoing evaluation after the product is on the market.
Post-market surveillance plan – Strategy for monitoring the device in real-world use.
Post-market clinical follow-up (PCMF) plan – Strategy for ongoing clinical data collection post-market.
Post-market clinical follow-up report – Outcomes of post-market clinical investigations.
Periodic safety update report (PSUR) – Rolling evaluation of the benefit-risk profile, adverse events, and field actions.