IVDR Class C Devices | Technical Documentation and Notified Body Review Checklist

If your diagnostic test falls under IVDR Class C, you can no longer self-certify it. A notified body must review your technical file, your quality system, and your performance data before you place the device on the EU market. That shift catches many teams off guard.

This guide gives you a practical checklist for IVDR Class C devices. You will learn what belongs in your technical documentation, what a notified body looks for, and where files stall. You will also see where the 2026 transition dates stand today, so you can plan the next 90 days with confidence.

Use it as a working tool. Share it with your regulatory, quality, and R&D teams.

What Is IVDR Class C? Devices, Rules and Examples

The In Vitro Diagnostic Regulation (IVDR, Regulation (EU) 2017/746) sorts every diagnostic test into Class A, B, C, or D. Seven rules in Annex VIII decide the class. The European Commission's MDCG 2020-16 classification guidance explains how to apply them.

Class C sits in the upper-middle of the risk scale. It covers tests with a high risk to the individual patient or a moderate risk to public health. A wrong result can lead to the wrong treatment, a missed diagnosis, or needless worry.

Typical examples include:

• Genetic tests and some cancer screening or staging assays
• Self-testing devices for certain infectious agents
• Companion diagnostics that decide who receives a specific therapy
• Some blood grouping assays

Under the old directive, manufacturers self-declared many of these tests. That option is gone. One industry estimate says about 80% of IVDs now need a notified body, compared with fewer than 10% before (Lindus Health).

Classification comes first, so confirm it early. A wrong class can wreck your whole timeline.

IVDR Class C Transition Deadlines: Where You Stand in November 2026

Dates matter most for legacy devices. A legacy device is a test that was legally on the EU market under the old IVDD before 26 May 2022. Amending Regulation (EU) 2024/1860 gives these devices extra time, but only if you hit set milestones.

Source: SGS Fimko, June 2026.

Both interim dates have now passed. If you met them, keep moving. You must also keep your quality system IVDR-ready, avoid significant changes to the device, and show steady progress.

If you missed a date, act now. The device likely loses transition status, so you need a full IVDR certificate before you place it on the market. However, BSI says manufacturers who already lodged an application can still transfer it to another notified body without losing transition status (BSI, April 2026).

New, non-legacy devices never had this extra time. They need certification first. Because legacy rules are strict, confirm your own status with a regulatory expert.

How Notified Bodies Assess IVDR Class C Devices

A notified body does not just read your file. It audits your system and tests your evidence against the regulation. For a Class C IVD, expect three reviews: your quality management system, your technical documentation, and your Summary of Safety and Performance.

Conformity Assessment Route for Class C IVDs

Most manufacturers follow the route built on Annex IX. The notified body audits your quality management system against ISO 13485 and IVDR Article 10. It then reviews technical documentation and your performance evaluation report. NSF's IVDR guide shows how Annex II works like a table of contents for this review.

Sampling of Class C Technical Documentation

Notified bodies cannot review every device in a large portfolio. For Class C, they sample files under MDCG 2019-13 guidance, usually by generic device group.

However, sampling does not mean the rest can be weak. A gap in one sampled file can raise questions across the whole group. Therefore, build every file to the same standard.

Realistic Timeline Expectations

Full conformity assessment often takes 18 to 24 months, according to MedDeviceGuide. Notified body capacity is limited. Early contact and a clean submission shorten the wait.

IVDR Class C Technical Documentation Checklist (Annex II and III)

A strong file is organized, searchable, and consistent. Team-NB, the association of notified bodies, names incomplete submissions and messy structure as leading causes of review delays (Team-NB best practice guidance).

Use the seven checks below. They follow Annex II and Annex III of the IVDR. Our team also covers this work in our technical documentation consulting service.

1. Device Description and Intended Purpose

Your intended purpose drives every other section. Write it once, then reuse the same wording everywhere.

• Analyte, specimen type, user, setting, and patient population
• All variants, configurations, and accessories
• Reference to earlier device generations
• Classification rationale that cites the Annex VIII rule

2. Design and Manufacturing Information

The notified body needs enough detail to understand how you design and build the test.

• Design stages, specifications, and key reagents
• Manufacturing flow and all sites
• Full details of critical suppliers and subcontractors, since auditors may visit them
• Software documentation, where applicable
• Stability, shelf-life, and transport data

3. GSPR Evidence Map

The General Safety and Performance Requirements (GSPR) sit in Annex I. Build a matrix that lists every requirement, marks it applicable or not, and links to the exact evidence.

A report alone does not prove compliance. You must show why each piece of evidence fits each requirement. Our Regulatory Insights hub explains how to turn a GSPR checklist into an evidence map.

4. Risk Management and Benefit-Risk Analysis

Risk management sits at the centre of your file. Follow ISO 14971 and link each hazard to a control and a verification result.

• Risk management plan and report
• Benefit-risk conclusion that matches your performance data
• Clear feedback loop from post-market data

5. Performance Evaluation for IVDR Class C Devices

This section often decides how smooth the review feels. The IVDR expects proof of scientific validity, analytical performance, and clinical performance (SimplerQMS).

• Performance evaluation plan and report
• Analytical data: sensitivity, specificity, precision, limit of detection, interference, and cross-reactivity
• Clinical performance data from studies or literature
• State-of-the-art justification

6. Labeling and Instructions for Use

Include every label, the instructions for use (IFU), and any marketing material that makes claims. Evidence must support each claim. Add UDI details and check language rules with your notified body.

7. Post-Market Surveillance Plan for Class C IVDs

Post-market surveillance is part of the file, not an afterthought. Include your surveillance plan, your post-market performance follow-up plan, and your vigilance process.

Class C manufacturers must also keep a periodic safety update report (PSUR) current and make it available to the notified body on request (Casus Consulting). The Summary of Safety and Performance (SSP) must stay accurate as well.

Notified Body Review Checklist for Your IVDR Class C Submission

Before you submit, run this final check. Each answer should be a confident yes.

• Does the application reference the correct quote or agreement number?
• Did you confirm language, portal, file naming, and labelling rules with the notified body?
• Does the intended purpose read the same in every document?
• Is the classification rationale clear and tied to Annex VIII?
• Does the GSPR matrix link each requirement to controlled evidence?
• Can a reviewer find any document within two clicks?
• Do analytical and clinical data support every claim on the label?
• Does the performance evaluation report match the risk file?
• Is your ISO 13485 system extended to meet IVDR Article 10?
• Do you list critical suppliers with audit access arranged?
• Are PMS, PMPF, and PSUR plans ready?
• Is the draft SSP complete and consistent with the file?

If you answer no to any item, fix it first. A rejected or stalled file costs far more time than a one-week delay now.

Why IVDR Class C Files Get Delayed (and How to Prevent It)

Most delays follow the same patterns. Spot them early.

Incomplete submissions. Missing sections trigger formal questions. Use the Annex II structure as your skeleton.

Messy structure. Reviewers lose time hunting for evidence. Use clear indexes and cross-references.

Inconsistent claims. The IFU says one thing and the performance report says another. Review all documents side by side.

Weak clinical evidence. Thin or poorly justified data prompts long question rounds. Plan studies early.

Uncontrolled changes. A change to intended purpose, design, or IFU may count as significant and end transition status. Review every change with your regulatory lead.

QMS gaps. An ISO 13485 certificate alone does not meet IVDR. You still need processes for PMS, vigilance, and registration (SGS).

Our ISO 13485 and QMS support helps close these gaps before the audit.

Companion Diagnostics and Self-Tests: Extra Steps for Class C

Two product types need extra attention.

First, companion diagnostics fall in Class C. Before it issues a certificate, the notified body must consult a medicines authority or the European Medicines Agency (Zamann Pharma). Tell your notified body early whether the partner drug uses a centralised procedure. That detail shapes the consultation.

Second, self-tests face tougher scrutiny because lay users run them. Plan usability studies with realistic users, and write simple, clear instructions.

For both types, align your clinical evidence with the exact claim. Broad claims need broad data.

How to Choose a Notified Body and an IVDR Partner

Picking the wrong notified body can cost months. Compare options on facts, not just quoted timing.

• Designation scope: Check the NANDO database to confirm the body covers your device codes under the IVDR.
• Capacity: Ask when they can start and how long each stage takes.
• Product experience: Choose a body that has assessed similar assays.
• Communication: Look for clear pre-application guidance. Pure Global's guide explains what to prepare.
• Cost clarity: Request a stage-by-stage quote.

You may also want outside help. Compare consultants on IVD experience, documentation samples, and notified body relationships. Our guide on selecting a notified body covers this in depth.

Regulatory professionals also swap practical tips in communities such as r/regulatoryaffairs and r/medicaldevices on Reddit. Treat those threads as peer experience, not legal advice.

A 90-Day IVDR Class C Action Plan

Use this plan to turn the checklist into progress.

Days 1 to 30: Assess. Confirm classification and legacy status. Run a gap assessment against Annex II and III. Check your QMS against IVDR Article 10. Review our IVDR transition planning insight to test eligibility.

Days 31 to 60: Build. Close performance evaluation gaps. Create the GSPR matrix. Update your risk file, labeling, and PMS plans. Draft the SSP.

Days 61 to 90: Prepare. Run an internal mock review. Fix inconsistencies. Confirm submission format with your notified body. Plan answers for the first question round.

Over these 90 days, assign one owner per section. Clear ownership prevents last-minute scrambles.

Get Expert Help With IVDR Class C Compliance

NKB Regovanta supports diagnostics manufacturers with EU IVDR strategy, gap assessments, technical files, and notified body coordination. Our team has delivered 350+ regulatory and quality projects since 2018.

Explore these pages to see how we can help:

• EU MDR and IVDR CE marking support
• In vitro diagnostics industry expertise
• Technical documentation and DHF services
• Audit and compliance support
• Global IVD registration services

Selling in India too? Read our guides on the IVD import license in India and how to register a medical device in India. Ready to talk? Book a consultation.

Frequently Asked Questions

What does IVDR Class C mean?

It means your diagnostic test carries a high risk to individual patients or a moderate risk to public health. A notified body must assess it before CE marking.

Is a notified body mandatory for Class C IVDs?

Yes. Only non-sterile Class A devices can self-certify. Class C always needs notified body involvement.

What is the Class C legacy transition end date?

Legacy Class C devices can stay on the market until 31 December 2028, but only if they met the 2026 application and agreement milestones.

What goes into IVDR Class C technical documentation?

The file covers device description, design and manufacturing, GSPR evidence, risk management, performance evaluation, labeling, and post-market surveillance, following Annexes II and III.

How long does IVDR Class C certification take?

Some sources estimate 18 to 24 months from application to certificate. Your timeline depends on file quality and notified body capacity.

Do companion diagnostics need extra review?

Yes. The notified body must consult a medicines authority or the EMA before it issues a certificate.

Quick Questions and Answers

What is an IVDR Class C device? It is a diagnostic test with a high individual risk or moderate public health risk, such as a genetic test or companion diagnostic.

Do I need a notified body for a Class C IVD? Yes. A notified body must review your technical documentation and quality system before you can CE mark the device.

What is the deadline for IVDR Class C legacy devices? You had to lodge an application by 26 May 2026 and sign an agreement by 26 September 2026. The final market date is 31 December 2028.

What should I include in a Class C technical file? Include the device description, design data, GSPR matrix, risk file, performance evaluation, labeling, and post-market plans.

How can I avoid notified body delays? Submit a complete, well-organized file with consistent claims. Confirm submission rules with your notified body first.

Where can I get help with IVDR Class C? An experienced regulatory consultancy such as NKB Regovanta can run a gap assessment and prepare your technical file.

Conclusion

IVDR Class C compliance rewards early, organized work. Confirm your classification and legacy status. Build a file that follows Annex II and III. Use the checklists above to test your readiness before the notified body does.

The next step is simple: run a gap assessment this month. Then fix the biggest gaps first. If you want a second set of eyes, contact NKB Regovanta for an IVDR Class C review.

This article is general information, not legal advice. Confirm your own requirements with your notified body and a qualified regulatory professional.