Updated IVDR Classification Guidance Brings Greater Clarity for IVD Manufacturers

Regulatory Update | In Vitro Diagnostic Medical Devices | October 2026

The European Commission has published a revised version of its guidance on the classification of in vitro diagnostic medical devices (IVDs) under the EU's In Vitro Diagnostic Medical Devices Regulation (IVDR).

Published on 9 September 2026, MDCG 2020-16 rev.5 – Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746 gives manufacturers and other stakeholders an updated reference for applying the IVDR classification rules.

The guidance is not legally binding, but it offers a common understanding of how the IVDR should be applied in practice and supports a more harmonised approach to classification across the EU. It's especially relevant for manufacturers developing, classifying, or preparing IVDs for the European market.

Why IVD Classification Matters

Under the IVDR, classification is a foundation of the regulatory pathway. IVDs are classified by the risk linked to their intended purpose and use, with each class carrying corresponding conformity-assessment requirements.

Getting classification right is far more than an administrative exercise. It can affect:

• The applicable conformity-assessment procedure

• Whether a notified body is involved

• The level of regulatory scrutiny

• Technical and clinical documentation

• Evidence requirements

• The overall timeline to market

  
  

A classification decision made too late, or based on an incomplete understanding of intended purpose, can create complications further down the regulatory pathway.

What Is MDCG 2020-16?

MDCG 2020-16 is guidance from the Medical Device Coordination Group (MDCG) to help stakeholders understand and apply the IVDR's classification rules, supporting consistent classification decisions across manufacturers.

The latest revision, rev.5, was published in September 2026, and the European Commission identifies it as the current guidance document specifically addressing IVD classification rules.

Classification Under the IVDR

The IVDR introduced a risk-based system that differs significantly from the previous IVD Directive. IVDs fall into Classes A, B, C, and D, with Class D the highest-risk category.

Classification follows the rules in Annex VIII of the IVDR, taking into account factors like the device's intended purpose and the characteristics of the test. That makes the manufacturer's definition of intended purpose especially important; a change in intended purpose can change the classification outcome, and with it the regulatory pathway.

What Does the Update Mean for Manufacturers?

The September 2026 revision doesn't create a new classification system. It provides an updated interpretation and practical reference for applying the existing one. Manufacturers should consider it when:

Developing a new IVD: Consider classification early so evidence and conformity-assessment planning align with the anticipated pathway.

Preparing technical documentation: Clearly document the rationale for your classification, supported by the applicable IVDR rules.

Reviewing an existing device: Check whether changes to intended purpose, claims, technology, or use environment could affect your current classification assessment.

Preparing for EU market entry: Confirm your classification rationale aligns with the current IVDR framework and relevant MDCG guidance.

Classification Drives the Wider Regulatory Pathway

Classification shouldn't be viewed in isolation. It determines the level of conformity assessment required: lower-risk devices may follow a very different route from higher-risk IVDs, which may involve greater notified-body involvement and additional assessment requirements.

An incorrect classification can therefore ripple well beyond the classification document itself:

Evidence strategy → Technical documentation → Conformity assessment → Notified-body engagement → EU market access

For international manufacturers, that makes classification a core part of early regulatory strategy.

Intended Purpose: The Anchor of Classification

Make sure the intended purpose is clear, consistent, and aligned with the actual product across all your documentation:

• Technical documentation

• Labelling

• Instructions for use

• Performance evaluation documentation

• Marketing claims

• Regulatory submissions

Inconsistent descriptions can create uncertainty about the appropriate pathway, so consider classification alongside your broader product-definition and claims strategy.

Who Should Pay Attention?

• IVD manufacturers developing products for the EU market

• International manufacturers preparing for European market entry

• Regulatory affairs teams responsible for IVDR compliance

• Authorised representatives supporting non-EU manufacturers

• Companies reviewing existing IVD classifications

• Developers of innovative diagnostic technologies

• Companies preparing technical documentation for conformity assessment

  
  

For businesses with IVD portfolios, this is also a good moment to review existing classification rationales against the latest guidance.

What Manufacturers Should Do Now

1. Review existing classification rationales. Confirm they remain consistent with the applicable IVDR rules.

2. Check the latest MDCG guidance. Make sure internal classification procedures reference the current version rev.5, published September 2026.

3. Review intended purpose and claims. Check that they remain aligned across technical and commercial documentation, and assess the regulatory implications of any changes.

4. Assess portfolio impact: Consider a broader portfolio review rather than reassessing products only when a new submission is prepared.

5. Align classification with conformity assessment. Understanding your likely class early helps anticipate the level of assessment and documentation required.

6. Keep monitoring MDCG updates. Don't rely indefinitely on documents prepared earlier in IVDR implementation; the framework continues to evolve.

ARQon Insight

The latest revision of MDCG 2020-16 underlines a key principle: classification is the starting point of the regulatory pathway, not the end of it.

For companies entering the European market, the classification decision influences almost every stage that follows. The September update is a chance to step back and ask:

Does our current classification rationale still accurately reflect our product, intended purpose, and regulatory strategy?

That question matters most for companies whose products, intended purposes, or claims have evolved since their original assessment. Reviewing classification early helps anticipate conformity-assessment requirements, plan evidence generation, and reduce the risk of regulatory surprises later.

A More Strategic Approach to IVDR Compliance

The IVDR has fundamentally changed the regulatory landscape for IVD manufacturers in Europe. As the framework matures, companies need to keep pace not only with the legislation but with the practical guidance the MDCG develops — which is why regulatory intelligence should be an ongoing activity, not a one-off task.

A connected process helps:

Regulatory Intelligence → Product Classification → Evidence Strategy → Conformity Assessment → Market Access → Post-Market Compliance

Key Takeaway

The European Commission published MDCG 2020-16 rev.5 on 9 September 2026, providing updated guidance on IVD classification under the IVDR. It isn't legally binding, but it provides a common understanding of how the classification rules should be applied and supports a more harmonised approach across the EU.

For IVD manufacturers, it's a timely prompt to review classification decisions, intended purposes, and regulatory strategies against the current framework.

The right classification can set the direction for the entire regulatory journey.

How ARQon Can Support You

ARQon supports healthcare and life-science companies with regulatory intelligence and market-access activities across international markets, including:

• Regulatory intelligence and monitoring

• EU market-entry strategy

• IVD regulatory pathway assessment

• Product classification support

• Regulatory gap analysis

• Technical and clinical documentation planning

• Conformity-assessment strategy

• Cross-border market-access planning

Stay Ahead. Stay Compliant. Stay Informed.

With ARQon Regulatory Intelligence.

Source

European Commission, Directorate-General for Health and Food Safety MDCG 2020-16 rev.5: Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746, published 9 September 2026.