MDR technical file gap analysis tool

Based on the customer request we developed a open source MDR Technical Documentation tool. This will help manufactures by...

  • Avoid missing core areas,
  • Provide an understanding on the requirements for MDR technical documentation,
  • Provide an understanding on how and what Notified Bodies assess during MDR technical documentation review.


S.No. Document Availability
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 (if applicable)
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 device and its mode of action
1.6 Summary of safety and clinical performance
1.7 Raw materials, components, packaging materials
1.7.1 Overview of all raw materials, components, packaging materials
1.7.2 Specifications of raw materials components/subassemblies
1.7.3 Specifications of packaging materials (primary and secondary packaging)
1.7.4 Certificates of analysis from the suppliers
1.7.5 Identification of substances that come into direct or indirect contact with the human body
1.8 Declaration on particular substances
1.8.1 Formal statement in a separate document if the device is manufactured utilizing tissues or cells of human origin, or their derivatives
1.8.2 Formal statement in a separate document if the device is manufactured utilizing tissues or cells of animal origin, or their derivatives
1.8.3 Formal statement in a separate document if the device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product within the meaning of point 2 of Article 1 of Directive 2001/83/EC, including a medicinal product derived from human blood or human plasma, as referred to in the first subparagraph of Article 1(8)
1.9 Previous and similar generations
1.9.1 Overview of the previous generation(s) of the device produced by the manufacturer
1.9.2 Overview of the similar generation(s) of the device available on the market in the European Union or on international markets
1.10 QM-System (only for MDD procedures)
1.11 European Authorized Representative valid agreement and disply of name and contact information in technicla file and information panels.
 
2 Labelling / instructions for use
2.1 Labelling
2.2 Instructions for use
 
3 Design and manufacturing 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 the manufacturing
3.2.1 Comprehensible description of manufacturing
3.2.2 Addresses of all manufacturing sites with information on the manufacturing steps
3.2.3 Information on specific processes and their validation
3.2.4 Information on controlled conditions under which certain manufacturing steps take place
3.3 Description of quality control
3.4 Outsourced processes, subcontractors
3.4.1 Overview in tabular format of outsourced processes and name/address of the executing companies
3.4.2 Evidence of qualification of subcontractors
3.4.3 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 Biocompatibility
6.1.1 Chemical characterisation of materials
6.1.2 Literature research
6.1.3 Test reports of performed biological tests
6.1.4 Summary evaluation of all data and test results for the finished product
6.1.5 Biological evaluation procedure, Plan & Justifications
6.2 Physical, chemical and microbiological testing Evidence of characterisation and preclinical suitability of the devices
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 Electrical safety and electromagnetic compatibility EMC (if applicable)
6.3.1 Planning and overview of performed tests
6.3.2 Test reports of performed tests
6.3.3 Evaluation of data and test results
6.4 Software verification and validation (if applicable)
6.4.1 Description of the software development process (e.g. according to EN 62304)
6.4.2 Description of the software design (e.g. according to EN 62304, EN 62366)
6.4.3 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)
6.5 Stability, including shelf life
6.5.1 Planning and overview of performed tests
6.5.2 Evidence that the devices meet the defined specifications during the defined shelf life. Results of the individual stability studies and evaluations on the following aspects
6.5.3 Storage stability (accelerated ageing (e.g. Arrhenius equation) and real-time data)
6.5.4 Transport stability
6.5.5 In-use stability
6.5.6 Concept for maintenance and servicing over the entire lifecycle
6.5.7 Evaluation of data and test results
6.6 Other pre-clinical tests (Other preclinical tests not addressed under 6.1 to 6.5)
6.6.1 Planning and overview of performed tests
6.6.2 Test reports of performed tests
6.6.3 Evaluation of data and test results
6.7 Clinical evaluation
6.7.1 Clinical evaluation Including information on the qualification of the author
6.7.2 Reviewed literature
6.7.3 Evidence of performed clinical investigations
6.7.4 Evidence of performed post-marketing clinical follow-up (PMCF)
6.7.5 Clinical Evaluation Report (Updated)
6.8 Medicinal products within the meaning of Directive 2001/83/EC (if applicable)
6.8.1 General information
6.8.2 Description of the composition of the active substance(s)
6.8.3 Statement regarding the reasonableness of the pharmaceutical content
6.8.4 GMP-certificate for the manufacturing of the medicinal product(s)
6.8.5 Description of the manufacturing steps relating to the medicinal product(s)
6.8.6 Control of the active substances (e.g. a declaration for the pharmaceutical quality)
6.8.7 Description of the in-process-controls of the medical device relating to the medicinal product
6.8.8 Description of the final quality controls of the medical device (e.g. identity, purity, content, release, compatibility)
6.8.9 Stability tests (or reference to the information given in chapter 6.5)
6.8.10 Toxicity - pharmacological/toxicological profile
6.8.11 Pharmacokinetics
6.8.12 Local compatibility
6.8.13 Clinical documentation (or reference to chapter 6.7)
6.8.14 Labelling / instruction for use (or reference to chapter 2)
6.9 Tissues or cells of animal origin (if applicable)
6.9.1 Explanation/justification for the use of material of animal origin in comparison to alternative products of non-animal origin
6.9.2 Evidence of the origin, rearing, feeding and age of the animals
6.9.3 Evidence of slaughter of animals and preparation/handling of tissues
6.9.4 Evidence of reduction/removal of transmissible pathogens
6.9.5 Description of the traceability for the products
6.9.6 Evidence of conformity with EN 22442-1, -2 und -3 and Regulation (EU) 722/2012
6.10 Substances that are intended to be introduced into the human body (if applicable)
6.10.1 Planning and overview of performed tests
6.10.2 Evidence of absorption, distribution, metabolism and excretion
6.10.3 Testing the interactions of those substances or of their metabolites in the human body with other devices, medicinal products or other substances, considering the target population and its associated medical conditions
6.10.4 Biocompatibility tests
6.11 CMR or endocrine-disrupting activity (if applicable)
6.11.1 Planning and overview of performed tests
6.11.2 Test reports of performed tests
6.11.3 Evaluation of data and test results
6.12 Sterile devices and devices to be sterilised (if applicable)
6.12.1 Description of environmental conditions during manufacturing or cleaning and packaging
6.12.2 Description of cleaning
6.12.3 Description of packaging
6.12.4 Bioburden (initial microbial count) before sterilisation (EN ISO 11737-1)
6.12.5 Pyrogens/endotoxins
6.12.6 Description of the sterilization method and validation of sterilization (if applicable)
6.12.7 ETO Resudal Testing if applicable
6.13 Measuring function (if applicable)
6.13.1 Planning and overview of performed tests
6.13.2 Test reports of performed tests
6.13.3 Evaluation of data and test results
6.14 Combination with other devices (if applicable)
6.14.1 Planning and overview of performed tests
6.14.2 Test reports of performed tests
6.14.3 Evaluation of data and test results
6.15 Hygienic (re-)processing of devices (if applicable)
6.15.1 Validation of cleaning/disinfection processes specified in the instruction for use
6.15.2 Validation of sterilisation processes specified in the instruction for use
6.15.3 Evidence of numbers of specified reprocessing cycles
6.15.4 Evidence of maintenance and functioning control specified in the instruction for use
 
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
 
Device Name*:
Technical File ID*:
Risk Class*:
Submitter Name:
Submitter Email*: