Follow Us:

Home › Medical Device Technical Documentation › MDR Technical Documentation Checklist

MDR Technical Documentation Checklist for Gap Analysis

Use this free MDR technical documentation checklist to run a gap analysis on your technical file. Mark each document as available, partial or missing, then use the result to plan the work needed before notified body review.

Start the ChecklistRequest a Gap Analysis
Overview

What Is an MDR Gap Analysis?

An MDR gap analysis compares the documents you have with what EU MDR 2017/745 expects. The result is a clear list of what is complete, what is incomplete and what still needs to be created.

It is useful before a first notified body submission, during an MDD to MDR transition, after a major design change, or when you take over a file prepared by someone else. This medical device technical documentation checklist turns the Annex II and III requirements into a list of documents you can tick off.

The checklist tells you whether a document exists. For an explanation of what each section must contain, see our guide to MDR technical documentation requirements. For the bigger picture, see our medical device technical documentation guide.

Contents

What Does the MDR Checklist Cover?

The checklist follows the Annex II and III structure in seven parts, so your gap analysis lines up with how a notified body reviews the file.

1

Device description and specification

Device overview, UDI, classification, operating principles, materials, variants and previous generations.

2

Information supplied by the manufacturer

Labels, packaging and instructions for use.

3

Design and manufacturing

Design stages, process validation, sites, suppliers and subcontractors.

4

General safety and performance requirements

GSPR checklist, standards and common specifications.

5

Benefit-risk and risk management

Risk management plan, analysis, report and benefit-risk conclusion.

6

Verification and validation

Testing, biocompatibility, software, sterilisation, shelf life and clinical evaluation.

7

Post-market surveillance

PMS plan, PMCF plan, PMS report or PSUR.

How to use it

How Do You Use the MDR Technical File Checklist?

  1. Confirm the class and routeCheck the class and conformity route first. Our guide to the types of MDR technical files explains the options.
  2. Gather current documentsCollect the latest approved version of every document in your file.
  3. Mark each lineRecord whether each document is available, partly available or missing.
  4. Check quality, not just presenceConfirm documents are current, signed and consistent with each other.
  5. Prioritise the gapsRank gaps by impact on safety, clinical evidence and certification timelines.
  6. Plan the remediationAssign owners and dates, then re-run the checklist before submission.
Checklist

Complete the MDR Technical Documentation Checklist

Work through each line and mark the availability of the document. When you finish, submit the form to receive a copy of your results.

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 display of name and contact information in technical 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 Usability 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 and -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 Residual 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*:
 
 

Do you need an email containing full details within 2 minutes?

Common findings

What Gaps Does an MDR Gap Analysis Usually Find?

Weak clinical evidence

Clinical evaluation reports that rely on equivalence without enough data, or lack a clear benefit-risk conclusion.

Incomplete GSPR checklist

Requirements marked as met without a specific document reference, or wrongly marked as not applicable.

Out-of-date evidence

Test reports against withdrawn standards, or risk files that do not reflect the current design.

No post-market plan

Missing PMS or PMCF plans, or plans that are generic rather than device-specific.

Inconsistent documents

Intended purpose, indications or warnings that differ between the IFU, risk file and clinical evaluation.

Missing UDI and SSCP

No Basic UDI-DI assigned, or no SSCP for implantable and class III devices.

Next steps

What Should You Do After the Gap Analysis?

This checklist suits regulatory affairs teams, quality managers, start-ups preparing a first CE marking and manufacturers moving legacy MDD devices to the MDR. Once you have the results:

  • Close the gaps that affect safety and clinical evidence first, because they take the longest.
  • Use our MDR technical file templates to create missing documents in the right structure.
  • Check that related QMS procedures are in place with our MDR procedures and templates.
  • Re-run the checklist before you submit to the notified body.

Want an expert MDR gap analysis?

Our consultants review your technical file and give you a prioritised gap report and remediation plan.

Request a QuoteContact Us
FAQs

MDR Technical Documentation Checklist: Common Questions

Is this MDR checklist free to use?

Yes. You can complete the checklist online at no cost and request a copy of your results through the form.

Does the checklist replace a notified body review?

No. It helps you find missing documents before submission. The notified body still assesses the content and quality of the evidence.

Can I use it for an MDD to MDR transition?

Yes. It is especially useful for legacy devices, because MDR technical documentation needs more detail on clinical evidence, UDI and post-market surveillance than MDD files.

How long does an MDR gap analysis take?

A focused review of one technical file usually takes a few days. Large portfolios or files with weak clinical evidence take longer.

Updated 8 November 2026 | Author: Sobha Augustine, Founder, I3CGLOBAL | Reviewed by: Asha Johnson, Manager, I3CGLOBAL