Before a Medical Device can be placed on the European market, it must meet specific regulatory requirements. Central to this approval process is the Technical Documentation, a structured and comprehensive set of documents that demonstrate the safety, performance, and regulatory compliance of the product throughout its entire life cycle.
WQS has been supporting manufacturers since 1993 in the creation, updating, and conformity assessment of technical documentation in accordance with Annexes II and III of Regulation (EU) 2017/745.
The Technical Documentation, also known as the Device Master File or Medical Device File, is a structured record that documents the safety, performance, and conformity of a medical device throughout its entire lifecycle.
According to the EU Medical Device Regulation (MDR, Regulation (EU) 2017/745), Technical Documentation is mandatory for all medical devices, regardless of their risk class. It forms the basis for the conformity assessment procedure and the CE marking.
The content requirements are defined in Annex II and Annex III of the MDR. The associated General Safety and Performance Requirements (GSPR) for product conformity are set out in Annex I of the MDR.
The technical documentation is a central element of the conformity assessment procedure and serves as the communication channel between the manufacturer and the Notified Body. The Notified Body comprehensively reviews the submitted documents and may consult external experts for specific technical or clinical aspects.
A complete, clearly structured, and comprehensible submission significantly accelerates the certification process and avoids costly rounds of additional requests.
The final submission of the technical documentation usually takes place at the end of the development process. However, it is often only at this late stage that deficiencies and avoidable expenses are identified. Therefore, it is strongly recommended to involve regulatory experts at an early stage in case of uncertainty.
A well-structured approach helps avoid unnecessary costs, such as incorrectly assumed testing requirements, expensive laboratory analyses, or superfluous validations. Such services are often highly specialized and cost-intensive, which can place a heavy burden on the project budget. This makes it all the more important, especially for projects with limited resources and tight deadlines, to strategically manage the effort and focus on the essential aspects of conformity.
Even carefully prepared technical documentation can trigger additional requirements during an audit. Notified Bodies don’t just review isolated individual documents, they evaluate the entire system for consistency, completeness, and traceability. Non-conformities often arise at interfaces: between the risk management file and the GruSuLa checklist, between the clinical evaluation and the PMS report, between the intended use and the classification protocol.
What matters then is structured resolution within the deadline. For major non-conformities, 15 to 30 days are allowed for the corrective action plan. For minor non-conformities, 60 to 90 days are allowed, although multiple minor deviations combined may be classified as major.
WQS offers consulting services for resolving deviations in the technical documentation of medical devices. We analyze the non-conformity report, prioritize based on severity and regulatory basis, and support the revision of the technical documentation through to formal closure.
We assist medical device manufacturers in developing or revising technical documentation in a focused, efficient, and comprehensible way.
Our services include:
Use our free sample table of contents for technical documentation as an initial overview of which documents should typically be included in MDR-compliant technical documentation.
In detail, the Technical Documentation is divided into the following chapters:
Chapter | Description |
| 1 | Product description and specifications |
| 2 | Information to be provided by the manufacturer |
| 3 | Design and manufacturing information |
| 4 | General Safety and Performance Requirements |
| 5 | Risk-benefit analysis and Risk Management |
| 6 | Verification and Validation of the Product |
| 7 | Post-Market Surveillance |
The table of contents of the TD (FB Table of contents TD) is used for precise referencing of the individual documents in the Technical Documentation. The individual information components of the chapters are explained below.
The product description establishes the regulatory identity of the medical device. It includes:
A properly documented intended purpose is the most common source of non-conformities in audits. WQS reviews your intended purpose for consistency with the classification, the General Requirements for Medical Devices (GruSuLa), and the clinical evaluation.
The instructions for use are a regulatory document in their own right with clear minimum content requirements in accordance with DIN EN 1041 and labeling requirements in accordance with DIN EN ISO 15223-1. They must be available in all official languages of the target markets.
Mandatory documents depending on product type:
Download the most important markings and pictograms for medical devices.
This chapter documents, including all outsourced processes, how the product is designed and manufactured.
Mandatory content:
The GSPR checklist documents compliance with the General Safety and Performance Requirements in accordance with Annex I of the MDR. Evidence is preferably provided via harmonized standards—if no harmonized standard is available, via Common Specifications or other suitable methods.
Mandatory content:
Further information on the Essential Safety and Performance Requirements.
Risk management is not a one-time documentation exercise, but a living, continuously updated document. The risk management file according to EN ISO 14971 includes:
Further information on the risk management dossier for medical devices EN 14971.
The scope of the verification and validation data depends directly on the intended use, the product type, and the risk class. For each product, the applicable tests must be derived from the product-specific standards (see List of Standards and Regulations, Chapter 04). The documentation thus contains results and critical analyses of all verification and validation tests and/or studies conducted to demonstrate the product’s conformity with the MDR and, in particular, the applicable essential safety and performance requirements.
Typical test areas depending on the product type:
Misjudgments regarding testing requirements (e.g., unnecessary or incorrectly defined laboratory tests) are among the most common avoidable cost traps in documentation preparation. WQS identifies early on which tests are actually required for your specific product before expensive laboratory contracts are awarded.
Post-market surveillance is an integral part of the technical documentation (Annex III MDR) and not an optional appendix. The findings obtained from PMS activities are directly incorporated into the updating of all relevant documents.
Mandatory documents depending on risk class:
| Document | Procedure according to VA PMS | Risk Class |
|---|---|---|
| PMCF-Plan | Planning the update of the clinical evaluation. Collection and evaluation of clinical data from the use of a CE-marked medical device. | All Classes |
| PMS-Plan | The planning of all activities to collect and review experience with the products in order to determine the need for corrective or preventive actions. | All Classes |
| PMS-Report | Market surveillance report including complaints, feedback, incidents, and trends, as well as evaluation and preventive and corrective actions. | Class I |
| PSU-Report | The updated safety report includes complaints, feedback, incidents, trends, evaluations, as well as preventive and corrective actions, risk-benefit assessment, sales volume, and usage. | Class IIa every 2 years; IIb & III annually |
| SSCP | A brief report on safety and clinical performance includes product identification, intended use, product description, alternatives, list of standards, clinical evaluation, follow-up, user profile and training, as well as residual risks, adverse effects, warnings, and precautions. | Class III + implants annually |
Further information on Post-Market Surveillance (PMS & PMCF).
For in vitro diagnostic medical devices (IVD), the requirements of the IVDR (Regulation (EU) 2017/746) apply. The basic structure of the technical documentation is comparable, but with specific differences in classification, performance evaluation, and documentation.
The content requirements are defined in Annex II and Annex III of the MDR. The documentation must cover at least the following areas:
The scope and depth of the documentation vary considerably depending on the product type and risk class. High-risk products require significantly more extensive evidence than lower-risk products.
For medical devices authorized outside the European legal framework, different or additional requirements may apply to the technical documentation.
Systematically address non-conformities in technical documentation according to MDR/IVDR:
Analysis, CAPA, documentation revision, submission to the Notified Body.
WQS supports you from initial prioritization through to closure confirmation.
The Technical Documentation is a comprehensive set of documents that proves a Medical Device complies with the EU MDR’s General Safety and Performance Requirements (GSPR). It is mandatory for all medical devices – regardless of risk class – to obtain CE Marking and enter the European market.
The structure and requirements for Technical Documentation are outlined in Annex II and Annex III of Regulation (EU) 2017/745 (MDR).
Yes. All Medical Devices – including Class I – must have complete and up-to-date Technical Documentation. However, the depth of documentation varies by Risk Class.
Instructions for Use (IFU) and labeling must comply with EN ISO 15223-1 and EN 1041 and include: indications, contraindications, warnings, sterilization instructions, UDI, CE mark and language requirements based on the target market.
The Risk Management File documents the entire risk management process, including the risk-benefit analysis, identified hazards, mitigation measures, and residual risks. It must be aligned with the product’s lifecycle and updated regularly.
A qualified consulting firm is familiar with the specific requirements of the Notified Body that issued the non-conformity report and can begin the analysis immediately. WQS assists manufacturers in systematically addressing non-conformities in the technical documentation: from prioritizing them as major or minor to providing formal confirmation of closure. Request an initial consultation at us.wqs.de/contact.
This page provides regulatory information and does not constitute legal advice. Regulatory requirements vary by jurisdiction.
Support for US companies to enter the European market. EU Rep, Certification, QM System, Technical Documentation, support of the Procedure, selection of a Notified Body, support of the Certification Procedure, preparation of a Clinical Evaluation, support of Clinical Studies, including the Logistical Concepts.
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