Technical documentation is the structured body of evidence a medical device manufacturer compiles to demonstrate that a device meets applicable safety, performance, and regulatory requirements. Under EU MDR 2017/745, its content is defined in Annex II and Annex III, and it forms the basis for conformity assessment and CE marking.
What is technical documentation?
Technical documentation is the complete record that shows how a device was designed, built, tested, and monitored, and why it is safe and performs as intended. It sits at the center of the regulatory lifecycle: manufacturers create it during development, Notified Bodies review it during conformity assessment, and auditors return to it throughout the product’s time on the market.
Under the EU Medical Device Regulation (MDR) 2017/745, Article 10(4) requires every manufacturer of a device other than a custom-made one to draw up and maintain this documentation according to Annex II and Annex III. The In Vitro Diagnostic Regulation (IVDR) 2017/746 mirrors that structure for IVDs. The same dossier goes by different names elsewhere: ISO 13485:2016 calls it the medical device file (Clause 4.2.3), and the older MDD referred to it as the technical file.
Why technical documentation matters in medical device development
A device cannot carry a CE Mark or complete most regulatory submissions without documentation that withstands regulatory scrutiny. For Class IIa, IIb, and III devices, a Notified Body directly reviews the technical documentation before issuing a certificate, and gaps in traceability remain one of the most common reasons certification is delayed.
Its importance extends beyond the initial certification. Technical documentation creates the traceable link between design inputs, risk management, verification, validation, clinical evidence, manufacturing, and post-market surveillance. When regulators investigate a complaint, conduct an inspection, or review a technical file, this documentation becomes the primary source of evidence.
Poorly organized or incomplete documentation frequently leads to longer review cycles, audit findings, increased remediation costs, and delayed market launches.
What technical documentation contains
EU MDR separates technical documentation into two primary sections.
Annex II defines the core technical documentation, while Annex III covers post-market surveillance documentation.
A complete technical documentation package typically includes:
- Device description and specification. Device variants, accessories, intended purpose, and the Basic UDI-DI.
- Design and manufacturing information. Manufacturing processes, design specifications, manufacturing sites, and production controls.
- General Safety and Performance Requirements (GSPR). A complete Annex I checklist linking every applicable requirement to supporting evidence.
- Benefit-risk analysis and risk management. Documentation developed in accordance with ISO 14971.
- Product verification and validation. Evidence including:
- Biocompatibility (ISO 10993)
- Electrical safety (IEC 60601-1)
- Software lifecycle documentation (IEC 62304)
- Usability engineering (IEC 62366-1)
- Verification and validation testing
- Clinical evidence, where applicable
- Clinical evaluation. Clinical Evaluation Report (CER), literature review, equivalence assessments, and supporting clinical evidence.
- Post-market surveillance documentation. As required under Annex III, including the PMS Plan, PMCF documentation where applicable, Periodic Safety Update Reports (PSUR), and other post-market records.
Each section supports the others. The GSPR checklist points to the risk management file, the risk management file references verification evidence, verification traces to design outputs, and clinical evidence supports safety and performance claims. Maintaining these cross-references is essential for successful regulatory review.
The FDA has moved toward similar documentation expectations. Since the Quality Management System Regulation (QMSR) became effective on February 2, 2026, 21 CFR Part 820 incorporates ISO 13485:2016 by reference, bringing FDA documentation expectations closer to the ISO medical device file concept. Although the FDA historically used the Device Master Record (DMR) and Design History File (DHF), the underlying evidence requirements remain substantially aligned.
Common challenges and best practices
Many manufacturers do not lack documentation—they lack organization. Evidence often exists across multiple departments, systems, and document versions, making it difficult for reviewers to verify compliance efficiently.
Building technical documentation continuously throughout product development is considerably more effective than assembling it immediately before submission.
Successful manufacturers generally:
- Maintain a single controlled version of every regulatory document.
- Keep the GSPR checklist updated as a live index that references current evidence.
- Update technical documentation whenever design changes, risk analyses, clinical evidence, or labeling changes.
- Ensure traceability between design inputs, risk controls, verification, validation, and post-market surveillance.
- Maintain document retention procedures so technical documentation remains available to regulators for at least 10 years after the final device is placed on the market, or 15 years for implantable devices, as required under EU MDR.
How SJML helps with technical documentation
SJML supports technical documentation development and maintenance through its Compliance-as-a-Service offering. Its QARA specialists prepare and maintain technical files, Design History Files (DHFs), GSPR checklists, ISO 14971 risk management documentation, Clinical Evaluation Reports (CERs), clinical evaluation plans, and EUDAMED-related documentation.
SJML also performs technical documentation remediation before Notified Body assessments and regulatory submissions. Because engineering, manufacturing, quality, and regulatory teams operate together, the documentation directly reflects actual product design, manufacturing records, testing evidence, and quality system activities, reducing inconsistencies across the submission package.
Frequently asked questions
Yes, in practice.
Technical file was the term used under the former Medical Device Directive (MDD), whereas EU MDR 2017/745 uses the term technical documentation.
ISO 13485 refers to the equivalent documentation as the medical device file, while the FDA historically divided similar information between the Device Master Record (DMR) and Design History File (DHF). Although terminology differs, each describes the evidence demonstrating regulatory compliance.
Yes.
Every medical device placed on the EU market requires technical documentation regardless of its classification.
Most Class I devices are self-certified without Notified Body review, but manufacturers must still prepare, maintain, and update complete technical documentation. The depth of evidence depends on the device’s risk class, intended use, and complexity.
For higher-risk devices, Notified Bodies review technical documentation during conformity assessment before issuing a CE certificate.
Competent Authorities may request the documentation during inspections, while internal auditors and MDSAP auditors review portions of the documentation during quality management system audits.
The manufacturer remains legally responsible for maintaining accurate, complete, and current documentation throughout the product lifecycle.
Under EU MDR 2017/745, manufacturers must retain technical documentation for at least 10 years after the final device covered by the Declaration of Conformity has been placed on the market.
For implantable devices, the retention period extends to at least 15 years.
The documentation must remain complete, current, and readily retrievable throughout the required retention period.
Related terms
- Design History File (DHF)
- General Safety and Performance Requirements (GSPR)
- Clinical Evaluation Report (CER)
- ISO 13485
- Conformity Assessment
