Technical Documentation for Medical Devices and IVDs

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A conformity assessment of medical devices or in vitro diagnostic medical devices (IVDs) in accordance with the Medical Device Regulation (MDR), formally Regulation (EU) 2017/745, and In Vitro Diagnostic Regulation (IVDR), formally Regulation (EU) 2017/746 requires complete technical documentation. For manufacturers, this documentation is therefore an essential prerequisite for market access. Companies seeking to place a medical device or IVD on the market for the first time under the MDR/IVDR often underestimate the scope and structure of the requirements. Incomplete or inconsistent documentation is a common cause of nonconformities and can thus lead to delays in the conformity assessment procedure. This article explains the structure, content, and typical sources of errors in technical documentation.

Technical documentation is essential for a medical device’s market access

Technical documentation is the key evidence that a medical device meets the general safety and performance requirements set forth in Annex I of the MDR. It forms the basis of every conformity assessment conducted by a Notified Body and, according to Article 10(4) of the MDR, must be kept up to date throughout the entire product lifecycle.

For companies new to the market, technical documentation is often the first concrete encounter with the nature and scope of regulatory requirements. Unlike an internal product file, it is a verified, auditable set of documents that Notified Bodies and market surveillance authorities must be able to understand. In practice, a lack of sufficient detail or consistency can lead to additional rounds of questions and, consequently, a longer and more costly path to market access.

Technical documentation is a “living” set of documents. Every product change, every new update to a medical device, and every new finding from the field have a direct impact on the content and consistency of the documentation. For AI-based medical devices, additional information must be documented regarding the dataset, the training and validation concept, performance metrics, potential risks of systematic bias, model change management, retraining, and Validation following changes.

Fundamentals: Legal framework and structure according to Annexes II and III of the MDR

The MDR specifies the fundamental content of the technical documentation in Annex II and, in Annex III, the supplementary requirements for post-market surveillance documentation. The specific structure and organization of the documentation may be tailored to the product, provided that all content required by regulations is verifiably documented.

To fulfill the GSPR, the manufacturer systematically documents which requirements from Annex I are applicable and what evidence (standards, assessment reports, Clinical data) is used to demonstrate conformity. A so-called GSPR matrix assigns the appropriate evidence and the referenced standard to each individual requirement. In practice, it represents one of the most important supporting documents for the Notified Body’s assessment of compliance with the general safety and performance requirements. Risk management according to ISO 14971 is closely intertwined with the technical documentation in terms of content, as its results are directly incorporated into several components of the technical documentation, particularly the demonstration of compliance with the GSPRs, the clinical evaluation, and the review of the benefit-risk analysis.

PMS reporting requirements by risk class

For post-market surveillance, Class I products require a PMS report (Art. 85 MDR). For higher classes, the Periodic Safety Update Report (PSUR), as required by Article 86 MDR, must be regularly updated. Updates are provided as needed, or at least every two years for Class IIa devices and at least annually for Class IIb and III devices. The PMCF plan - that is, the systematic, proactive collection of clinical data after placing the device on the market - is, where necessary, an integral part of the PMS plan. A summary of its key findings is incorporated into the PSUR.

For implantable devices and Class III products, the draft Summary of safety and clinical performance (SSCP, Art. 32 MDR) is also part of the documentation to be submitted to the Notified Body. The validated version is subsequently made publicly available via EUDAMED.

A similar structure applies to IVD manufacturers: Annexes II and III of the IVDR also require technical documentation including a performance evaluation, albeit with their own deadlines and classification system (A through D instead of I through III). The basic principles - namely, completeness, consistency, and ongoing updating - apply equally to both regulations.

Note: The Commission proposal to amend the MDR and IVDR (COM (2025) 1023), submitted in December 2025, currently provides, among other things, for reduced PSUR update intervals. The proposal is currently undergoing the legislative process. Until it is adopted, the deadlines mentioned above remain unchanged.

Practical procedure

A consistent structure based on the MDR annexes facilitates both internal maintenance and review by the Notified Body. In practice, the following procedure has proven effective:

1. Clearly formulate the product and intended use description, including indications, contraindications, and user groups.
2. Create a GSPR matrix: requirement, evidence, referenced standard, responsibility.
3. Incorporate the risk management file in accordance with ISO 14971 and link it to the relevant verification/validation results.
4. Reference the clinical evaluation or performance evaluation without duplicating it unnecessarily.
5. Maintain PMS/PMCF documents in accordance with Annex III as a separate, continuously updated component.

Team-NB’s Best Practice Guidance on the Submission of Technical Documentation in Accordance with Annexes II and III (April 21, 2026, Version 4) provides practical, up-to-date guidance on how Notified Bodies perform testing for completeness and consistency. Well-documented traceability between requirements, evidence, and documentation reduces the likelihood of follow-up inquiries.

As part of the Conformity assessment, the Notified Body typically reviews the technical documentation in several phases. A formal completeness check precedes a substantive technical review, during which specific areas - such as Risk management, clinical evaluation, or software lifecycle documentation - are scrutinized in detail. Inquiries are an integral part of the procedure. Their number can be reduced from the outset through consistent, well-referenced documentation.

Challenges and risks

• Inconsistent product description:
  Discrepancies between the intended purpose, label, and application documents lead to inquiries from the Notified Body.
• Incomplete GSPR evidence:
  Missing justifications for the non-applicability of individual requirements are common review points.
• Lack of maintenance throughout the life cycle:
  The technical documentation must be updated on an ongoing basis. Outdated information is noticed during audits.
• Interfaces with other documents:
  Without clear links between the risk management file, clinical evaluation, and technical documentation, redundancies or gaps may arise.
• Resource requirements:
  The scope of the documentation is often underestimated by companies new to the market, especially when dealing with complex software.

FAQ

What is included in the technical documentation under the MDR?
It includes, in particular, the product description, design and manufacturing information, evidence of GSPR compliance, risk management, and, in accordance with Annex III, the documents related to post-market surveillance. The documentation must be kept up to date throughout the entire product lifecycle.

How long must the technical documentation be retained?
According to Article 10(8) of the MDR, for at least ten years after the last product was placed on the market; for implantable devices - with a few exceptions - for at least 15 years.

What role does the ISO 14971 standard play in technical documentation?
Risk management in accordance with ISO 14971 provides key evidence that is incorporated into several components of the technical documentation, particularly the clinical evaluation and the benefit-risk analysis.

What are the requirements for the technical documentation of software as a medical device?
In addition to the Annex II requirements, Notified Bodies expect software to include lifecycle documentation in accordance with IEC 62304, as well as a traceable link between requirements, architecture, verification, and risk management. Furthermore, evidence regarding usability (IEC 62366-1), information security/cybersecurity, software validation, and change management is expected.

Conclusion

Consistent technical documentation aligned with the requirements of Annexes II and III is an essential prerequisite for a smooth conformity assessment and must be continuously maintained and updated throughout the entire product lifecycle. Establishing the appropriate documentation structure early on reduces the need for subsequent rework and minimizes follow-up inquiries from the Notified Body.

With our gap analysis, we assess your existing documentation against the requirements of Annexes II and III of the MDR. Our process and documentation support then guide you through the structured development, optimization, and ongoing maintenance of your technical documentation. Please feel free to schedule a no-obligation initial consultation.

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This article is intended solely for general informational purposes and does not constitute legal advice. All content was reviewed by experts prior to publication and is regularly checked for currency, completeness, and accuracy. Despite careful preparation and quality control, errors, omissions, or changes in the legal situation that have occurred in the meantime cannot be ruled out.