IVDR technical documentation: Team-NB Version 2 guidance

Team-NB adopted Version 2 of its best practice guidance for IVDR technical documentation on 3 September 2025. The document explains how manufacturers can structure and present the information required under Annexes II and III of Regulation (EU) 2017/746 for review by a Notified Body.

The IVDR establishes the binding legal requirements. The Team-NB Version 2 position paper is a non-binding interpretation of those requirements developed by European Notified Bodies. It is a practical starting point, but it does not replace the Regulation or the submission procedures of the manufacturer’s selected Notified Body.

What changed in Team-NB Version 2?

Version 2 replaces the original guidance issued on 25 February 2023. Team-NB describes the revision as an update to multiple sections, with clearer wording and improved formatting.

The 36-page document now provides a structured overview of:

• device description, variants, accessories and classification;
• information supplied by the manufacturer, including labels, instructions for use and the declaration of conformity;
• design and manufacturing information;
• General Safety and Performance Requirements;
• benefit-risk analysis and risk management;
• product verification and validation;
• software, usability, stability and metrological traceability;
• performance evaluation and clinical evidence;
• post-market surveillance and post-market performance follow-up;
• the Summary of Safety and Performance for Class C and Class D devices;
• additional considerations for companion diagnostics.

The guidance is comprehensive, but Team-NB states that a Notified Body may request additional information during its assessment.

Is the Team-NB document an IVDR technical documentation template?

No. Team-NB Version 2 is not a fillable technical documentation template and does not prescribe a single dossier format for every Notified Body.

Manufacturers can use it as a submission checklist and structural reference. The final dossier must still reflect the device, its risk classification, intended purpose, applicable conformity assessment route and the specific submission requirements of the selected Notified Body.

Before submitting, manufacturers should confirm the Notified Body’s accepted language, portal, file naming conventions, document labelling rules and administrative requirements.

IVDR technical documentation structure

The technical documentation must remain clear, organised, readily searchable and unambiguous. It must also reflect the current status of the device throughout its lifecycle.

Documentation area	What the file should demonstrate
Device description and intended purpose	Consistent device names, identifiers, variants, intended users, specimen types, target populations and intended purpose
Information supplied by the manufacturer	Alignment between labels, instructions for use, packaging, claims and the declaration of conformity
Design and manufacturing	Traceable design inputs and outputs, manufacturing processes, critical materials, sites and subcontractors
GSPR documentation	Applicability of each requirement, method of conformity, standards or other solutions applied, supporting evidence and document references
Risk management	Connection between identified hazards, risk controls, benefit-risk conclusions and production or post-production information
Verification and validation	Complete evidence for analytical performance, clinical performance, stability, usability, software and other applicable characteristics
Performance evaluation	Alignment between the Performance Evaluation Plan, scientific validity, analytical performance, clinical performance and the Performance Evaluation Report
Post-market documentation	Post-market surveillance, PMPF, complaints, vigilance, trend reporting and the applicable PMS report or PSUR
Summary of Safety and Performance	Traceable, current information for Class C and Class D devices in accordance with the applicable IVDR and MDCG requirements

Key checks before submitting an IVDR technical file

Team-NB identifies incomplete submissions and poorly structured documentation as common causes of review delays. Manufacturers should therefore complete the following checks before submission:

1. Confirm the Notified Body’s requirements. Verify acceptable languages, submission methods, file organisation and document labelling before lodging the application.
2. Submit complete and current reports. Abbreviated, partial or outdated reports may not provide sufficient evidence for the assessment. Verification reports should represent the final device configuration being submitted.
3. Maintain consistency across documents. Device names, Basic UDI-DI and UDI-DI values, intended purpose, indications, contraindications, warnings and other repeated information should remain consistent throughout the dossier and application forms.
4. Map every applicable GSPR. The GSPR checklist should identify whether each requirement applies, how conformity is demonstrated, which standards or other solutions are used and where the supporting evidence is located.
5. Explain missing or non-applicable evidence. Empty sections should not replace a documented scientific, technical or regulatory justification.
6. Keep the documentation current. Technical documentation is a lifecycle record. Changes arising from design control, performance evaluation, risk management, vigilance and post-market activities must be incorporated through the manufacturer’s quality management system.

How MDx CRO supports IVDR technical documentation

MDx CRO supports IVD manufacturers with:

• Annex II and Annex III gap assessments;
• technical documentation authoring and remediation;
• device description, intended purpose and classification reviews;
• GSPR mapping and standards documentation;
• risk management and benefit-risk documentation;
• performance evaluation plans and reports;
• scientific validity reports;
• PMS, PMPF, PMS reports and PSURs;
• labelling, UDI and declaration of conformity reviews;
• pre-submission consistency checks and Notified Body response support.

If you are preparing a new dossier or remediating an existing technical file, explore our regulatory affairs and technical documentation services or contact MDx CRO to discuss the documentation gaps affecting your submission.

Frequently asked questions