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Technical documentation EU Authorized representative Clinical evaluation PRRC services Risk management Notified bodies Quality management system Post-market surveillance
General medical devices and equipment In vitro diagnostics (IVD) Medical Device Software (MDSW)
CE-marking process for medical devices CE-marking process for in vitro diagnostics MDR technical documentation checklist IVDR technical documentation checklist Technical documentation checklist for MDSW PRRC under MDR or IVDR
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Technical documentation checklist for medical device software (MDSW)


MDSW can fall under either MDR or IVDR. Technical documentation should be prepared accordingly. You can utilise our MDSW technical documentation checklist below to evaluate if your TD is in line with MDR.



Below is the checklist to provide understanding of the requirements and structure of MDR-compliant technical documentation for Medical Device Software. Simply scroll down to access the checklist.



Fill out the Device field, check the checkboxes for available documents and N/A boxes for documents that do not apply to your device and print out or create a PDF-document.

MDR technical documentation checklist for medical devices

Date:



Sec. Document Available N/A
1 Device description and specification
1.1 General description of the device, its variants and its intended purpose
1.1.1 Name and address of the manufacturer
1.1.2 Overview of devices/ device groups/device types
1.1.3 All trade names under which the device is placed on the market
1.1.4 Specification of the device
1.1.5 UMDNS/GMDN classification (if applicable)
1.1.6 Technical specifications of the device
1.1.7 Variants/components/configurations and accessories of the device
1.1.8 Exact software version
1.1.9 Explanations of new characteristics and new intended purposes/indications
1.2 UDI
1.3 Designation / Classification
1.4 Declaration of Conformity (DoC)
1.5 Description of the principles of operation of the software
1.6 Summary of safety and clinical performance (if applicable)
1.7 Previous and similar generations
1.7.1 Overview of the previous generation(s) of the device produced by the manufacturer
1.7.2 Overview of the similar generation(s) of the device available on the market in the European Union or on international markets
1.8 QM-System (only for MDD procedures)
1.9 European Authorised Representative valid agreement and disply of name and contact information in technicla file and information panels.
 
2 Labelling / instructions for use
2.1 Labelling / user interface
2.2 Instructions for use / user manual / admin manual
 
3 Design and development information
3.1 Description of the design
3.1.1 Description of the applied design process
3.1.2 Identification of all sites where design processes were performed
3.2 Description of quality control
3.3 Outsourced processes, subcontractors
3.3.1 Overview in tabular format of outsourced processes and name/address of the executing companies
3.3.2 Evidence of qualification of subcontractors
3.3.3 Quality assurance agreements with subcontractors for outsourced production steps and in the case of sterile devices for outsourcing of packaging and/or sterilisation
 
4 General Safety and Performance Requirements
4.1 Systematic evidence of compliance with the General Safety and Performance Requirements
4.2 List of applied standards and common specifications
 
5 Benefit-risk analysis and risk management
5.1 Risk management plan
5.2 Risk analysis including risk control measures
5.3 Risk management report including the evaluation of residual risks and the evaluation of benefit-risk ratio
5.4 Usablity reports
 
6 Product verification and validation
6.1 Software verification and validation
6.1.1 Description of the software development process (e.g. according to EN 62304)
6.1.2 Description of the software design (e.g. according to EN 62304, EN 62366)
6.1.3 Verification of the software usability according to IEC 62366
6.1.4 Validation of the software as used in the finished device: e.g. a. summary results of verifications, validations and tests performed (in-house or in a simulated or in a real user environment)
6.2 Other pre-clinical tests (Other preclinical tests not addressed under 6.1 to 6.5)
6.2.1 Planning and overview of performed tests
6.2.2 Test reports of performed tests
6.2.3 Evaluation of data and test results
6.3 Clinical evaluation
6.3.1 Clinical evaluation Including information on the qualification of the author
6.3.2 Reviewed literature
6.3.3 Evidence of performed clinical investigations
6.3.4 Evidence of performed post-marketing clinical follow-up (PMCF)
6.3.5 Clinical Evaluation Report (Updated)
6.4 Measuring function (if applicable)
6.4.1 Planning and overview of performed tests
6.4.2 Test reports of performed tests
6.4.3 Evaluation of data and test results
6.5 Combination with other devices (software and hardware environment)
6.5.1 Planning and overview of performed tests
6.5.2 Test reports of performed tests
6.5.3 Evaluation of data and test results
 
7 Post-market surveillance
7.1 Post-market surveillance plan (PMS-Plan)
7.2 Post-market clinical follow-up plan (PMCF-Plan)
7.3 Periodic safety update report according to Article 86
7.4 Post-market surveillance report according to Article 85

Other checklists for MDR/IVDR compliance

MDR technical documentation checklist

IVDR technical documentation checklist

Technical documentation checklist for medical device software (MDSW)

MDR-compliant quality system documentation checklist

MDR-compliant quality system documentation checklist for medical device software

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