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MDR Technical File GAP Analysis Checklist

Based on the customer request we developed an open-source MDR Technical File Gap Analysis Checklist. This will help manufactures by…

  • Avoid missing core areas,
  • Provide an understanding of the requirements for MDR technical documentation,
  • Provide an understanding of how and what Notified Bodies assess during MDR Technical Documentation / Technical File review.
1Device description and specification
1.1General description of the device, its variants and its intended purpose
1.1.1Name and address of the manufacturer
1.1.2Overview of devices/ device groups/device types
1.1.3All trade names under which the device is placed on the market
1.1.4Specification of the device
1.1.5UMDNS/GMDN classification (if applicable)
1.1.6Technical specifications of the device
1.1.7Variants/components/configurations and accessories of the device
1.1.8Exact software version (if applicable)
1.1.9Explanations of new characteristics and new intended purposes/indications
1.3Designation / Classification
1.4Declaration of Conformity (DoC)
1.5Description of the principles of operation of the device and its mode of action
1.6Summary of safety and clinical performance
1.7Raw materials, components, packaging materials
1.7.1Overview of all raw materials, components, packaging materials
1.7.2Specifications of raw materials components/subassemblies
1.7.3Specifications of packaging materials (primary and secondary packaging)
1.7.4Certificates of analysis from the suppliers
1.7.5Identification of substances that come into direct or indirect contact with the human body
1.8Declaration on particular substances
1.8.1Formal statement in a separate document if the device is manufactured utilizing tissues or cells of human origin, or their derivatives
1.8.2Formal statement in a separate document if the device is manufactured utilizing tissues or cells of animal origin, or their derivatives
1.8.3Formal 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)
1.9Previous and similar generations
1.9.1Overview of the previous generation(s) of the device produced by the manufacturer
1.9.2Overview of the similar generation(s) of the device available on the market in the European Union or on international markets
1.10QM-System (only for MDD procedures)
1.11European Authorized Representative valid agreement and disply of name and contact information in technicla file and information panels.
2Labelling / instructions for use
2.2Instructions for use
3Design and manufacturing information
3.1Description of the design
3.1.1Description of the applied design process
3.1.2Identification of all sites where design processes were performed
3.2Description of the manufacturing
3.2.1Comprehensible description of manufacturing
3.2.2Addresses of all manufacturing sites with information on the manufacturing steps
3.2.3Information on specific processes and their validation
3.2.4Information on controlled conditions under which certain manufacturing steps take place
3.3Description of quality control
3.4Outsourced processes, subcontractors
3.4.1Overview in tabular format of outsourced processes and name/address of the executing companies
3.4.2Evidence of qualification of subcontractors
3.4.3Quality assurance agreements with subcontractors for outsourced production steps and in the case of sterile devices for outsourcing of packaging and/or sterilisation
4General Safety and Performance Requirements
4.1Systematic evidence of compliance with the General Safety and Performance Requirements
4.2List of applied standards and common specifications
5Benefit-risk analysis and risk management
5.1Risk management plan
5.2Risk analysis including risk control measures
5.3Risk management report including the evaluation of residual risks and the evaluation of benefit-risk ratio
5.4Usablity reports
6Product verification and validation
6.1.1Chemical characterisation of materials
6.1.2Literature research
6.1.3Test reports of performed biological tests
6.1.4Summary evaluation of all data and test results for the finished product
6.1.5Biological evaluation procedure, Plan & Justifications
6.2Physical, chemical and microbiological testing Evidence of characterisation and preclinical suitability of the devices
6.2.1Planning and overview of performed tests
6.2.2Test reports of performed tests
6.2.3Evaluation of data and test results
6.3Electrical safety and electromagnetic compatibility EMC (if applicable)
6.3.1Planning and overview of performed tests
6.3.2Test reports of performed tests
6.3.3Evaluation of data and test results
6.4Software verification and validation (if applicable)
6.4.1Description of the software development process (e.g. according to EN 62304)
6.4.2Description of the software design (e.g. according to EN 62304, EN 62366)
6.4.3Validation 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)
6.5Stability, including shelf life
6.5.1Planning and overview of performed tests
6.5.2Evidence that the devices meet the defined specifications during the defined shelf life. Results of the individual stability studies and evaluations on the following aspects
6.5.3Storage stability (accelerated ageing (e.g. Arrhenius equation) and real-time data)
6.5.4Transport stability
6.5.5In-use stability
6.5.6Concept for maintenance and servicing over the entire lifecycle
6.5.7Evaluation of data and test results
6.6Other pre-clinical tests (Other preclinical tests not addressed under 6.1 to 6.5)
6.6.1Planning and overview of performed tests
6.6.2Test reports of performed tests
6.6.3Evaluation of data and test results
6.7Clinical evaluation
6.7.1Clinical evaluation Including information on the qualification of the author
6.7.2Reviewed literature
6.7.3Evidence of performed clinical investigations
6.7.4Evidence of performed post-marketing clinical follow-up (PMCF)
6.7.5Clinical Evaluation Report (Updated)
6.8Medicinal products within the meaning of Directive 2001/83/EC (if applicable)
6.8.1General information
6.8.2Description of the composition of the active substance(s)
6.8.3Statement regarding the reasonableness of the pharmaceutical content
6.8.4GMP-certificate for the manufacturing of the medicinal product(s)
6.8.5Description of the manufacturing steps relating to the medicinal product(s)
6.8.6Control of the active substances (e.g. a declaration for the pharmaceutical quality)
6.8.7Description of the in-process-controls of the medical device relating to the medicinal product
6.8.8Description of the final quality controls of the medical device (e.g. identity, purity, content, release, compatibility)
6.8.9Stability tests (or reference to the information given in chapter 6.5)
6.8.10Toxicity - pharmacological/toxicological profile
6.8.12Local compatibility
6.8.13Clinical documentation (or reference to chapter 6.7)
6.8.14Labelling / instruction for use (or reference to chapter 2)
6.9Tissues or cells of animal origin (if applicable)
6.9.1Explanation/justification for the use of material of animal origin in comparison to alternative products of non-animal origin
6.9.2Evidence of the origin, rearing, feeding and age of the animals
6.9.3Evidence of slaughter of animals and preparation/handling of tissues
6.9.4Evidence of reduction/removal of transmissible pathogens
6.9.5Description of the traceability for the products
6.9.6Evidence of conformity with EN 22442-1, -2 und -3 and Regulation (EU) 722/2012
6.10Substances that are intended to be introduced into the human body (if applicable)
6.10.1Planning and overview of performed tests
6.10.2Evidence of absorption, distribution, metabolism and excretion
6.10.3Testing 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
6.10.4Biocompatibility tests
6.11CMR or endocrine-disrupting activity (if applicable)
6.11.1Planning and overview of performed tests
6.11.2Test reports of performed tests
6.11.3Evaluation of data and test results
6.12Sterile devices and devices to be sterilised (if applicable)
6.12.1Description of environmental conditions during manufacturing or cleaning and packaging
6.12.2Description of cleaning
6.12.3Description of packaging
6.12.4Bioburden (initial microbial count) before sterilisation (EN ISO 11737-1)
6.12.6Description of the sterilization method and validation of sterilization (if applicable)
6.12.7ETO Resudal Testing if applicable
6.13Measuring function (if applicable)
6.13.1Planning and overview of performed tests
6.13.2Test reports of performed tests
6.13.3Evaluation of data and test results
6.14Combination with other devices (if applicable)
6.14.1Planning and overview of performed tests
6.14.2Test reports of performed tests
6.14.3Evaluation of data and test results
6.15Hygienic (re-)processing of devices (if applicable)
6.15.1Validation of cleaning/disinfection processes specified in the instruction for use
6.15.2Validation of sterilisation processes specified in the instruction for use
6.15.3Evidence of numbers of specified reprocessing cycles
6.15.4Evidence of maintenance and functioning control specified in the instruction for use
7Post-market surveillance
7.1Post-market surveillance plan (PMS-Plan)
7.2Post-market clinical follow-up plan (PMCF-Plan)
7.3Periodic safety update report according to Article 86
7.4Post-market surveillance report according to Article 85
Device Name*:
Technical File ID*:
Risk Class*:
Submitter Name:
Submitter Email*: