Technical documentation is a central component in the approval of a medical device. Due to the new MDR, some requirements have been dropped, changed or newly added. The following table gives you an overview of the main changes between the MDD Directive and the new MDR:
Comparison of technical documentation between old MDD and new MDR
| CATEGORY | DETAIL REQUIREMENT | MDD | MDR |
| DEVICE DESCRIPTION AND SPECIFICATION | Product/trade name | (✓) | ✓ |
| General description | ✓ | ✓ | |
| Classification and rationale | (✓) | ✓ | |
| Variations, configurations, accessories | (✓) | ✓ | |
| Pictures | ✓ | ✓ | |
| IDENTIFICATION | UDI DI | – | ✓ |
| USE IN ACCORDANCE WITH THE INTENDED PURPOSE | Intended purpose | ✓ | ✓ |
| Intended user | – | ✓ | |
| Patient population | – | ✓ | |
| Contra- /indication | – | ✓ | |
| Intended applications | (✓) | ✓ | |
| Accessories | – | ✓ | |
| Interaction with other products | (✓) | ✓ | |
| Applied design levels | ✓ | ✓ | |
| SETUP | Essential function | – | ✓ |
| Parts, components, composition | ✓ | ✓ | |
| Drawings, diagrams, explanations | ✓ | ✓ | |
| Description of materials (with physical contact) | – | ✓ | |
| Technical specification | – | ✓ | |
| Calculations | ✓ | – | |
| SUPPORTING MATERIALS | Brochures, Catalogues | – | ✓ |
| Instructions for use | ✓ | ✓ | |
| Labelling | ✓ | ✓ | |
| Packaging | – | ✓ | |
| MANUFACTURING | Development and production phases including validation of process and tools, testing of product (pre- and clinical data required) | ✓ | ✓ |
| Indication of all locations, including all suppliers and subcontractors involved in the development and manufacturing process | – | ✓ | |
| QUALITY ASSURANCE | Performance and safety requirements according to Annex I | ✓ | ✓ |
| References to evidence of all basic requirements | ✓ | ✓ | |
| Verification and validation to demonstrate the essential requirements with the justification of the choice in particular concerning: safetyperformanceFor measurement function: accuracyinteroperability | ✓ | ✓ | |
| Citation of any harmonised standards or other standards | ✓ | ✓ | |
| RISK MANAGEMENT | Risk-benefit analysis | ✓ | ✓ |
| Risk management plan | ✓ | ✓ | |
| Risk acceptance | ✓ | ✓ | |
| Risk analysis (also by fitness for use, production, and downstream phase) | (✓) | ✓ | |
| Risk control measures | ✓ | ✓ | |
| Risk management results and measures | ✓ | ✓ | |
| DATA FROM RESEARCH AND DEVELOPMENT (PRE-CLINICAL AND CLINICAL DATA) | Results of pre-tests (e.g. laboratory, simulation, animal testing) including description of test design e.g. with reference to: biocompatibilityelectrical safetybiological and toxic materials (not examined in detail here)software (see next point) | (✓) | ✓ |
| Necessary clinical evaluation | (✓) | ✓ | |
| SOFTWARE LIFECYCLE PROCESSES | Verification | (✓) | ✓ |
| Validation | ✓ | ✓ | |
| Architecture | – | ✓ | |
| Development processes | ✓ | ✓ | |
| Tests with different hardware | – | ✓ | |
| Tests „in-house“ und in the use environment | – | ✓ | |
| POST-PRODUCTION | Post-Market Surveillance plan | – | ✓ |
| Post-Market Surveillance protocol | – | ✓ | |
| OTHER (DEPENDING ON THE PRODUCT) | Biocompatibility | – | (✓) |
| Electrical safety | – | (✓) |