Technical Documentation for Medical Devices under the EU MDR
Before a Medical Device can be placed on the European market, it must comply the technical documentation under the EU Medical Device Regulation (MDR) 2017/745. It is the core of every conformity assessment and the document a Notified Body reviews most closely before CE marking. According to a 2025 survey by Team-NB, the association of European Notified Bodies, around 65 percent of submitted MDR files lack at least half of the required information [Team-NB Survey 2025].
Under Annexes II and III of the MDR, the technical documentation covers seven areas: device description, information supplied by the manufacturer, design and manufacturing, General Safety and Performance Requirements (GSPR), risk management, verification and validation, and post-market surveillance. WQS has supported medical device manufacturers since 1993, in Germany and the United States. We prepare, update and review technical documentation for all risk classes, from the first device description to the closure of open Notified Body findings.
What is technical documentation under the EU MDR?
Technical documentation is the structured evidence that a medical device meets the General Safety and Performance Requirements (GSPR) of the MDR. It demonstrates safety, performance and conformity across the entire device lifecycle and is mandatory for every medical device, regardless of risk class (Article 10(4) MDR). Without it, neither a conformity assessment nor CE marking is possible.
The content requirements are set out in Annexes II and III of the MDR. The General Safety and Performance Requirements themselves are defined in Annex I. Technical documentation is not a closed archive: findings from post-market surveillance, design changes and new versions of standards must be incorporated on an ongoing basis.
How does EU technical documentation compare with an FDA submission?
For U.S. manufacturers, the most important difference is the regulatory model. The FDA clears or approves a device on the basis of a premarket submission such as a 510(k), De Novo request or PMA. In the EU, there is no government approval. The manufacturer demonstrates conformity through a conformity assessment procedure, which for most device classes involves a Notified Body, a private organization designated by an EU member state. The technical documentation is the basis of that assessment and must be kept up to date as long as the device is on the market.
| Aspect | FDA (United States) | EU MDR |
|---|---|---|
| Market access | 510(k) clearance, De Novo or PMA approval by the FDA | Conformity assessment, CE marking by the manufacturer, Notified Body certificate for Class Is/Im/Ir, IIa, IIb, III |
| Core document | Premarket submission plus design records under QMSR | Technical documentation under Annexes II and III |
| Unique identification | UDI-DI in GUDID | Basic UDI-DI and UDI-DI in EUDAMED |
| Local presence | U.S. agent for foreign establishments | EU Authorized Representative for non-EU manufacturers (Article 11) |
What role does technical documentation have in the Conformity Assessment Procedure?
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 reviews the submitted documentation in full and may involve external experts for specific technical or clinical aspects. A complete, clearly structured and traceable submission shortens the review because every round of additional questions extends the timeline. For Class IIa and IIb devices, the Notified Body assesses the technical documentation on a representative sampling basis.
Technical file, technical documentation or design dossier: which term is correct?
Many names circulate for the same dossier. In the U.S. and internationally, the terms technical file, CE technical file, CE file or EU technical file are common. Legally, the MDR only uses technical documentation, and this page uses the term consistently to avoid misunderstandings with the Notified Body. Several U.S. terms sound similar but refer to different documents:
| Term | Origin | Relation to MDR technical documentation |
|---|---|---|
| Technical documentation | EU MDR and IVDR, Annexes II and III | The legally binding term |
| Technical file, CE technical file, EU technical file | Industry usage, MDD era | Informal synonym |
| Design dossier | MDD, Class III devices | Predecessor format, replaced by technical documentation under the MDR |
| STED (Summary Technical Documentation) | GHTF, international | Older summary format, related in content |
| Design History File (DHF), Device Master Record (DMR) | FDA, former 21 CFR 820 | U.S. design and production records. Under QMSR replaced by ISO 13485 terminology, e.g. the medical device file |
| Medical device file | ISO 13485, clause 4.2.3 | Device file within the QMS, overlaps with technical documentation |
| Device Master File (MAF) | FDA | A confidential FDA submission, typically by suppliers. Not a synonym for technical documentation |
Our Medical Device Consulting for Technical Documentation
We assist medical device manufacturers in developing or revising technical documentation in a focused, efficient, and comprehensible way.
Our services include:
- Initial creation and updating of Technical Documentation in accordance with MDR and IVDR
- Creation or revision of the Product Description
- Support with Instructions for Use and labeling
- Clinical evaluation and post-market surveillance
- International approvals
- Preparation for audits by Notified Bodies (TÜV SÜD, TÜV Rheinland, BSI, DEKRA, NSAI, SGS)
- Consulting on the resolution of deviations in the Technical Documentation of medical devices
- Risk analysis and risk management in accordance with EN ISO 14971
- Establishment and certification of the quality management system in accordance with ISO 13485
MDR Table of Contents and Supporting Documents
Structure of the technical documentation according to Annexes II & III of the MDR
Technical documentation under Annexes II and III MDR consists of seven areas. All seven apply to every risk class. What changes with the class is the scope, the depth of evidence and certain mandatory documents, such as the periodic safety update report (PSUR) from Class IIa or the summary of safety and clinical performance (SSCP) for Class III and implantable devices.
| Chapter | Content | MDR reference |
|---|---|---|
| 01 | Device description and specification | Annex II, Section 1 |
| 02 | Information supplied by the manufacturer: Labeling and Instructions for Use | Annex II, Section 2 |
| 03 | Design and manufacturing information | Annex II, Section 3 |
| 04 | General Safety and Performance Requirements | Annex II, Section 4 and Annex I |
| 05 | Risk Management according to EN ISO 14971 | Annex II, Section 5 |
| 06 | Product verification and validation | Annex II, Section 6 |
| 07 | Post-market surveillance | Annex III |
The device description establishes the regulatory identity of the device. Classification, GSPR and clinical evaluation all build on it. It includes:
- Product list: Product groups, including product design, supplier information, classification, and coding (BUDI-DI); to be used when there is more than one product group
- Declaration on specific substances: Specific substances (not) used in the products or during manufacturing (medicinal products, tissues or cells of human or animal origin or their derivatives, and nanomaterials)
- Classification protocol: Classification taking into account the intended use, definition of classification rules, and classification according to Annex VIII of the MDR
- Declaration of conformity: Issued in accordance with classification (Class I, Class Is/r/m/IIa/b, or Class III)
- Product description:
With intended use: General product description including item no., BUDI-DI, (contra)indications, mode of action, coding and classification, as well as product characteristics, application specifications, and labeling
Without intended use: General product description including item no., BUDI-DI, mode of action, coding and classification, as well as product characteristics and labeling; Review of the Notified Bodies’ requirements for documenting the intended use - Product Specification: General product description including classification and coding, tolerances and dimensions, as well as material specifications, description of biological properties, and specific details regarding manufacturing and release (e.g., production conditions, sterilization process, and references to valid VAs and AAs)
- Raw materials, components, and packaging materials: Description of raw materials in the areas of manufacturing, product, and packaging, including their intended contact with the body (direct contact, indirect contact, no contact) and their specifications
- Packaging Specification: Description of each packaging level, including material, manufacturer/supplier (including certifications), dimensions, and, if applicable, details on the sealing process and packaging contents
- Intended Purpose: General product description, including item number, BUDI-DI, (contra)indications, mode of action, and classification, as well as application specifications; Application when using the product description without intended purpose
The intended purpose is one of the most frequent sources of Notified Body findings. If it differs between device description, classification, clinical evaluation and instructions for use, the documentation is not consistent. For U.S. manufacturers, a common cause is reusing the FDA indications for use statement without adapting it to the MDR definition of intended purpose (Article 2(12)).
The instructions for use (IFU) are a regulatory document in their own right. Minimum content follows from Annex I, Section 23 MDR. EN ISO 20417, the successor to EN 1041, is used for implementation, and EN ISO 15223-1 for symbols. Each EU member state determines which languages are required (Article 10(11) MDR). Unlike in the U.S., English-only labeling is not sufficient for most EU markets. See pictograms and labeling requirements.
- Reprocessing instructions: Minimum content includes the scope of application of the instructions for use, safety warnings, instructions for cleaning and sterilization, manual pre-cleaning (if applicable), mechanical cleaning and disinfection, packaging and sterilization, as well as disposal instructions; details on the compliant and validated reprocessing process for reusable medical devices in accordance with DIN EN ISO 17664 and VA Reprocessing
- Assessment of Language Requirements: List of target markets and their language requirements, along with their implementation; preparation for marketing in multiple markets to ensure compliance with the various language requirements for the information to be provided (instructions for use, labeling, and, if applicable, implantation card)
- Labeling Checklist: Checklist for the labeling of medical devices in the instructions for use, on the sterile packaging if applicable, and on the implantation card if applicable; if labeling on the medical device is not possible due to size constraints, the next higher level of packaging must be labeled; single-use medical devices are also exempt from the requirement to label the product
- Instructions for use: Minimum content includes the scope of application of the instructions for use, product information, intended use, indications and contraindications, general and safety instructions, application, and, where applicable, instructions and a reference to the reprocessing instructions. Instructions for use in accordance with DIN EN 1041 and labeling in accordance with DIN EN ISO 15223-1 in the languages accepted in the Member States where the product is to be sold (see Assessment of Language Requirements). Instructions for use are exceptionally dispensable for Class I and IIa products if the safe use of these products is guaranteed without instructions for use
- Implantation Card: Product identification details (name, lot number, UDI, and manufacturer), all warnings and precautions, expected service life, and any other information necessary to ensure safe use; to be provided by the manufacturer for implantable products in the languages accepted in the Member States where the product is to be sold (see Assessment of Language Requirements)
- Master label: Manufacturer, instructions for use, item number, batch number, and UDI, as well as the CE mark plus all other product-relevant markings in accordance with DIN EN ISO 15223-1 in the languages accepted in the Member States where the product is to be sold (see Assessment of Language Requirements)
This chapter documents how the device is designed and manufactured, including all outsourced processes:
- Outsourced processes, suppliers: List of all entities/suppliers where design and manufacturing activities are performed, including existing certificates
- Design drawings: Standard-compliant technical drawings for each medical device, identified by part number
- Material data sheets: Complete information on the materials and excipients used (e.g., suppliers’ material data sheets)
- Manufacturing specification: Flowchart/sequence diagram that enables an understanding of the design phases the product has undergone; complete information on the manufacturing processes and their validation, ongoing monitoring, and testing of the finished product (e.g., outgoing goods and in-process controls)
The GSPR checklist documents how each requirement of Annex I MDR is met. Evidence is preferably provided through harmonized standards. Where none exist, common specifications or other suitable methods may be used. FDA-recognized consensus standards are often identical to the EN ISO versions, but the edition and harmonization status must be checked for the EU. Required content:
- Essential Safety and Performance Requirements: Documentation of compliance with the Essential Safety and Performance Requirements according to Annex I of the MDR; evidence of the implementation of the standards in various documents (reports, plans, etc.)
- List of Standards and Regulations: List of all generally applicable and product-specific standards and regulations with identification number, title, and edition; harmonized standards are to be applied if available; if not applicable, the latest edition
More on the General Safety and Performance Requirements (GSPR).
Risk management is not a one-time documentation exercise, but a living, continuously updated document. The risk management file according to risk management file under ISO 14971 includes:
- Risk management plan: scope, risk acceptance criteria, and responsible persons
- Risk analysis and assessment: hazard identification, harm scenarios, and risk mitigation measures
- Benefit-risk analysis: as part of the clinical evaluation and the GruSuLa checklist
- Risk management report: documentation of residual risks and the final overall assessment
This chapter contains the results and critical analysis of all verification and validation tests and studies that demonstrate conformity with the GSPR. Scope and type depend on intended purpose, device type and risk class and are derived from the device-specific standards. Typical test areas include biocompatibility, CMR substances, electrical safety and EMC, usability, measuring function, software, stability and shelf life, sterility, substance-based devices, combination with other devices, medicinal substances, animal tissues or cells, and the clinical evaluation.
Incorrectly assumed test requirements are among the most common avoidable cost drivers. WQS clarifies which tests are actually required for the specific device before laboratory testing is commissioned, including which existing FDA test reports can be reused.
Post-market surveillance is an integral part of the technical documentation, not an optional appendix. Its results feed directly back into risk management, clinical evaluation and the IFU.
| 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 |
Is there an MDR technical file template?
There is no official template. The MDR defines in Annexes II and III what must be demonstrated, not the format or document structure. Many Notified Bodies publish their own submission guidance, which should be reflected in the structure.
As a starting point, WQS provides a free sample table of contents. It shows which documents are typically referenced in MDR-compliant technical documentation and can be used as a checklist for your own structure. A template does not replace device-specific evidence: a complete table of contents will not pass a review if test reports, clinical data or the risk assessment do not address the specific device.
How do you prepare for an MDR audit by a Notified Body?
Notified Bodies do not review individual documents in isolation. They assess whether the technical documentation is consistent as a whole. Planning matters as much as preparation. Technical documentation is often compiled at the end of development, when tests have been commissioned and design decisions made. Considering EU requirements during design planning, ideally in parallel with the FDA strategy, avoids duplicate tests, incorrectly defined lab work and unnecessary validations. WQS prepares documentation and audit together with your team and can manage communication with the Notified Body. The assessment itself remains with the Notified Body. Most procedures also require a quality management system under ISO 13485.
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.
Will my technical documentation pass the audit?
Use this checklist to see whether your Technical Documentation covers the core requirements of the EU MDR before you approach a Notified Body.
Likely triggers for deficiencies
None of the core requirements assessed is open.
Orientation aid, not a conformity assessment within the meaning of the EU MDR (2017/745). Annexes II and III and the assessment by the Notified Body are decisive.
What to do if the Notified Body identifies non-conformities in the technical documentation?
Even carefully prepared technical documentation can lead to findings. They often arise at interfaces: between risk management file and GSPR checklist, between clinical evaluation and PMS report, or between intended purpose and classification rationale.
What counts is structured resolution within the deadline. Deadlines are set by the Notified Body. In practice, manufacturers often have 15 to 30 days to submit a corrective action plan for major non-conformities and 60 to 90 days for minor ones. Several minor non-conformities on the same topic can be graded as a major.
WQS analyzes the findings report, prioritizes by severity and regulatory basis and supports the revision through formal closure. More on resolving non-conformities in the technical documentation.
How long does it take to prepare MDR technical documentation?
Depending on the starting point, preparation takes from a few weeks to several months. The main factors are the risk class, the availability of test reports and clinical data, the number of device variants and whether an existing FDA file can be used as a basis. External testing such as biocompatibility or sterilization validation can take several months on its own. According to Team-NB, the complete MDR certification procedure takes 13 to 18 months in most cases [Team-NB Survey 2025]. A complete, consistent submission shortens this timeline, because every round of questions extends it.
How does WQS support EU technical documentation?
Since 1993, we have guided medical device and IVD manufacturers through conformity assessments in Europe, and today also support U.S. manufacturers from St. Petersburg, Florida. Our consultants prepare technical documentation, revise existing files and identify the evidence that is actually missing.
Gap analysis
Action plan agreed
Missing evidence is prioritized, tests and responsibilities are defined.
Technical documentation
We prepare or revise the chapters together with your team.
Submission prepared
Consistency check, table of contents and coordination with the Notified Body.
Findings closed
We support the review through to certification.
What applies to technical documentation for IVDs under the IVDR?
In vitro diagnostic medical devices (IVDs) are governed by Regulation (EU) 2017/746 (IVDR). Technical documentation also follows Annexes II and III, but differs from the MDR in three respects. IVDs are assigned to Classes A to D under the seven rules of Annex VIII IVDR, and except for non-sterile Class A devices a Notified Body is involved. Instead of a clinical evaluation, a performance evaluation under Article 56 and Annex XIII is required, based on scientific validity, analytical performance and clinical performance. Post-market, PMPF replaces PMCF, and a PSUR is required for Classes C and D (Article 81).
For legacy devices certified under Directive 98/79/EC, staggered transition periods apply if the conditions of Regulation (EU) 2024/1860 are met: until December 31, 2027 for Class D, December 31, 2028 for Class C and December 31, 2029 for Class B and sterile Class A devices. For U.S. manufacturers, note that the IVDR classification does not map directly to FDA Class I to III. More on IVD consulting and registration.
What are the legal requirements for technical documentation?
- Article 10(4) MDR: manufacturer’s obligation to draw up and keep technical documentation up to date
- Article 11 MDR: EU Authorized Representative for manufacturers outside the EU
- Annex I MDR: General Safety and Performance Requirements
- Annexes II and III MDR: technical documentation and post-market surveillance documentation
- Article 52 and Annexes IX to XI MDR: conformity assessment procedures
- Articles 8 and 9 MDR: harmonized standards and common specifications
- MDCG guidance, e.g. MDCG 2019-9 (SSCP) and MDCG 2022-21 (PSUR), available from the European Commission
- Annexes II and III IVDR for in vitro diagnostic devices
The proposed targeted revision of the MDR and IVDR (COM(2025) 1023) is still in the legislative process. Until it is adopted, the current MDR applies unchanged.
Technical Documentation • MDR
Technical documentation incomplete or findings still open?
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.
Frequently Asked Questions
What is the Technical Documentation under MDR and why is it required?
Technical documentation is the central body of evidence with which a manufacturer demonstrates that a medical device conforms to the EU Medical Device Regulation (MDR) 2017/745. It is required for CE marking and market access in the European Economic Area and, under Annexes II and III MDR, includes the device description, risk management, clinical evaluation, test reports and post-market surveillance documentation.
What are the main sections of the Technical Documentation according to MDR?
Under Annexes II and III MDR, technical documentation covers seven areas: device description and specification, information supplied by the manufacturer, design and manufacturing, General Safety and Performance Requirements, benefit-risk analysis and risk management, verification and validation including clinical evaluation, and post-market surveillance.
Where are the Technical Documentation requirements defined in the MDR?
The structure and requirements for Technical Documentation are outlined in Annex II and Annex III of Regulation (EU) 2017/745 (MDR).
Is Technical Documentation required for Class I Devices?
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.
What information must be included in the "Instructions for Use" and labeling?
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.
What role does the Risk Management File play in Technical Documentation?
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.
How do I find a consulting firm that can help me resolve non-conformities in technical documentation?
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.
Can I use my FDA 510(k) documentation for the EU MDR?
Partly. Test reports, design verification data, software documentation and the ISO 14971 risk management file can often be reused. A GSPR checklist, a clinical evaluation under Annex XIV, post-market surveillance documentation and labeling in the required EU languages usually have to be created or substantially extended. Substantial equivalence to a predicate device is not accepted as a route to conformity under the MDR.
Is there an MDR technical file template?
There is no official template, because the MDR regulates content, not format. WQS provides a free sample table of contents as orientation. A template structures the documentation but does not replace the device-specific evidence that the Notified Body reviews.
How long does it take to prepare MDR technical documentation?
Preparation takes from a few weeks to several months, depending on the risk class, available test reports and clinical data. The subsequent certification procedure with a Notified Body takes 13 to 18 months in most cases, according to Team-NB.
What does MDR technical documentation cost, including consulting?
Costs depend on the risk class, the number of variants, existing test reports and clinical data and the scope of consulting. Laboratory testing, Notified Body fees, an EU Authorized Representative and translations are added. A reliable estimate is possible after a gap analysis of the existing documents.
Where must the UDI appear in the technical documentation?
The Basic UDI-DI is stated consistently in the device description, the EU declaration of conformity, the Notified Body certificate, the SSCP and in the EUDAMED registration. The UDI carrier appears on labels and packaging levels and, for implantable devices, on the implant card. A UDI-DI assigned for the FDA GUDID can be used if issued by an EU-designated issuing entity such as GS1, but the Basic UDI-DI has no FDA equivalent.
Does a medical device need approval in the EU?
Not in the sense of FDA clearance or approval. Medical devices undergo a conformity assessment procedure under the MDR, involving a Notified Body depending on the risk class. After a successful assessment, the manufacturer issues the EU declaration of conformity and affixes the CE marking. Technical documentation is the basis in every case.
Sources and Regulatory Framework
- European Parliament & Council of the EU: Regulation (EU) 2017/745 on Medical Devices (MDR), Official Journal of the European Union, May 5, 2017 – eur-lex.europa.eu
- European Parliament & Council of the EU: Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices (IVDR) – eur-lex.europa.eu
- European Commission – Medical Devices: MDCG 2019-9: Summary of Safety and Clinical Performance and MDCG Guidelines on Technical Documentation – health.ec.europa.eu
- TÜV SÜD: Annex II: Technical documentation – tuvsud.com
- European Commission – NANDO Database (List of Notified Bodies under the MDR) – ec.europa.eu/growth/tools-databases/nando/
- The European Association of Medical devices Notified Bodies: Medical Device Survey 2025 – team-nb.org
This page provides regulatory information and does not constitute legal advice. Regulatory requirements vary by jurisdiction.
