Technical Documentation Requirements Under EU MDR and IVDR 

Technical documentation is a fundamental requirement under the European Union Medical Device Regulation (EU MDR 2017/745) and In Vitro Diagnostic Medical Device Regulation (EU IVDR 2017/746). It provides evidence that a Medical Device or IVD meets applicable safety, performance, and regulatory requirements throughout its lifecycle. Regulatory compliance is supported through comprehensive documentation, rigorous assessment by Notified Bodies, representative sampling approaches for certain device classes, and ongoing surveillance activities to ensure continued conformity and market access.

Introduction

The European Union Medical Device Regulation (EU MDR 2017/745) and In Vitro Diagnostic Medical Device Regulation (EU IVDR 2017/746) have significantly strengthened Regulatory documentation for Medical Devices and in vitro diagnostic devices placed on the European market. 

A cornerstone of both regulations is the requirement for comprehensive technical documentation, which serves as evidence that a device complies with applicable safety, performance, and regulatory requirements. The assessment of MDR technical documentation by Notified Bodies is a critical component of conformity assessment and certification processes.¹

Purpose of Technical Documentation

Technical documentation provides detailed information demonstrating that a device meets the General Safety and Performance Requirements outlined in Annex I of the MDR and IVDR. It enables regulators and notified bodies to evaluate the design, intended purpose, manufacturing processes, risk management activities, clinical or performance evidence, and post-market surveillance arrangements associated with a device. The documentation must be maintained throughout the device lifecycle and updated whenever significant changes occur.¹

Core Components of Technical Documentation

Under Annex II and Annex III of the MDR and IVDR, manufacturers are required to maintain comprehensive technical documentation demonstrating conformity with applicable regulatory requirements. Key components include:^2–4

• Device description and specifications
• Information supplied with the device (e.g., labelling and instructions for use)
• Design and manufacturing information
• Documentation demonstrating compliance with general safety and performance requirements (GSPRs)
• Risk management documentation
• Product verification and validation data
• Clinical evaluation (MDR) or performance evaluation (IVDR) evidence
• Post-market surveillance documentation

These elements collectively provide evidence of the device’s safety, performance, and Regulatory compliance requirements throughout its lifecycle.

Regulatory Framework for Technical Documentation Assessment

The MDR and IVDR establish specific requirements regarding the review of technical documentation. Articles 52(4) and 52(6) of the MDR, together with Articles 48(7) and 48(9) of the IVDR, require notified bodies to assess technical documentation before issuing certificates. For high-risk devices, the regulations mandate review of representative devices selected through a structured sampling approach. 

The technical documentation assessment forms part of the overall conformity assessment process described in Annex IX. In addition, Annex VII requires Notified Bodies to develop and maintain sampling plans to ensure systematic and representative coverage of device portfolios.¹

Sampling Requirements Under MDR and IVDR

A key feature of the Regulatory documentation is the use of representative sampling to assess technical documentation for certain device classes (Table 1).¹

Table 1

Additional requirements include:¹

• Selected devices must be associated with a Basic UDI-DI.
• The sampled devices should be representative of the range of devices included in the manufacturer’s application.
• The outcome of the technical documentation assessment contributes directly to the certification decision.

Depth and Scope of Technical Documentation Review

The MDR and IVDR emphasise that the depth of review for sampled Class IIa, Class IIb, Class B, and Class C devices should be equivalent to the assessment performed for higher-risk devices such as Class III, Class IIb implantable, and Class D devices.

The assessment covers all applicable requirements of the Device approval process:¹

• Annex I (general safety and performance requirements)
• Annex II (technical documentation)
• Annex III (technical documentation on post-market surveillance)

Notified Bodies are expected to perform a comprehensive review rather than a limited or administrative verification. Assessment records must be sufficiently detailed to allow an independent reviewer to understand the device, the assessment process, and the rationale behind regulatory conclusions.

Where a device has multiple variants, models, or sizes under the same Basic UDI-DI, the review must also evaluate how differences among these configurations have been addressed and justified within the technical documentation.¹

Surveillance and Ongoing Documentation Review

Technical documentation review does not end once certification has been granted. During the surveillance period, Notified Bodies must continue assessing technical documentation according to an established sampling plan. At least one technical documentation assessment must be conducted annually.

Additionally, the entire device range covered by a certificate must be reviewed over the certificate’s validity period, which may extend up to five years. To ensure representative coverage, the guidance recommends that approximately 15% of devices within each category or generic device group be sampled during the certification cycle, although certain reductions may be permitted under specific circumstances.

The surveillance process also incorporates information obtained from vigilance reporting, post-market surveillance activities, scientific literature reviews, and clinical data monitoring. These findings may influence future sampling priorities and technical documentation reviews.¹

Special Cases and Exemptions

Certain device categories are exempt from representative sampling and require individual technical documentation assessments.

Under the MDR, Class IIb implantable devices generally require a full technical documentation assessment for each device and the issuance of a dedicated EU technical documentation assessment certificate. These devices are therefore excluded from sampling approaches.

Similarly, under the IVDR technical file, Class B and Class C devices intended for self-testing, near-patient testing, and companion diagnostics require assessment of the technical documentation for all devices covered by the certificate. In such cases, manufacturers must submit dedicated applications, and Notified Bodies issue EU technical documentation assessment certificates following review.¹

Conclusion

Technical documentation is a fundamental element of compliance under the EU MDR and IVDR. The regulations require comprehensive documentation demonstrating conformity with safety and performance requirements and mandate rigorous assessment by Notified Bodies. 

Through representative sampling, risk-based selection criteria, ongoing surveillance, and detailed review processes, the MDR and IVDR aim to ensure that Medical Devices and IVDs placed on the European market consistently meet high standards of safety, quality, and performance. Consequently, manufacturers must establish robust technical documentation systems and maintain them throughout the product lifecycle to facilitate certification, regulatory compliance requirements, and continued market access.

References 

1. md_mdcg_2019_13_sampling_mdr_ivdr_en_0.pdf. Accessed June 9, 2026. https://health.ec.europa.eu/system/files/2020-09/md_mdcg_2019_13_sampling_mdr_ivdr_en_0.pdf

2. MassimoP. ANNEX II (PART 1). Medical Device Regulation. July 25, 2019. Accessed June 9, 2026. https://www.medical-device-regulation.eu/2019/07/25/annex-ii/

3. MassimoP. ANNEX II (PART 2). Medical Device Regulation. July 25, 2019. Accessed June 9, 2026. https://www.medical-device-regulation.eu/2019/07/25/annex-ii-part-2/

4. MassimoP. ANNEX III. Medical Device Regulation. July 25, 2019. Accessed June 9, 2026. https://www.medical-device-regulation.eu/2019/07/25/annex-iii/