MDCG 2020-16 Rev.3 classification rules provide essential guidance on how to classify in vitro diagnostic medical devices (IVDs) under the EU IVDR. The latest revision enhances clarity, addresses known ambiguities, and strengthens consistency in how Annex VIII classification rules are applied. For manufacturers, understanding these updates is critical to ensuring correct classification, smoother conformity assessment, and regulatory compliance.
This article covers two areas:
- the key updates introduced in Rev.3, and
- how the guidance applies to major IVD categories, including Companion Diagnostics (CDx), Next‑Generation Sequencing (NGS), self‑testing, and Near‑Patient Testing (NPT).
Key Updates in MDCG 2020-16 Rev.3 classification rules
New Definition of “Kit”
Rev.3 introduces a formal definition of a kit:
A set of components packaged together and intended for a specific IVD examination or part of it.
This definition improves consistency in how kit-based products are classified.
Rule 3(a) – Updated Examples
Monkeypox Virus has been added to the list of organisms under this rule, reflecting current public‑health priorities.
Rule 4(a) – Clarifications for Self‑Testing IVDs
Rev.3 provides detailed guidance for the classification of self‑testing devices:
- Devices for detecting pregnancy, fertility, cholesterol, glucose, erythrocytes, leukocytes, and bacteria in urine remain Class B.
- Devices detecting both a Class C marker and an exception marker are Class C, following implementing rules 1.8–1.9.
- Devices meeting the criteria under rules 1.8–1.9 can be Class D, including self‑tests for HIV from fingerprick blood.
Information Society Services
Devices used within online services are considered self‑testing devices only when the lay user performs part of the testing procedure.
Specimen-only actions (e.g., stabilizing or collecting the sample) do not make a device self‑testing.
Standalone Specimen Receptacles
Specimen-only collection kits offered online are not classified as self‑testing.
Examples in Rev.3
- Glucose meters/strips for capillary blood → Class C
- Calprotectin tests with lay interpretation via image upload → Class C
- HIV antibody self‑tests (fingerprick) → Class D
Rule 5(c) – Expanded Rationale and Examples
Definition and Classification
Specimen receptacles are defined as containers (evacuated or non‑evacuated, empty or prefilled) for the primary containment and transport of biological specimens.
They are classified as Class A, as they do not perform any analytical function.
Use in Kits
Specimen receptacles included in kits for specimen collection remain Class A, even when accompanied by non‑IVD components.
User Actions
Actions such as gargling, pipetting, or adding buffer—when required solely to maintain specimen integrity—are not considered part of the testing procedure.
Combination Use
Specimen receptacles and the subsequent IVD are classified separately under implementing rule 1.2.
Examples
- Standalone urine cups, stool containers, saliva tubes, blood spot cards → Class A
- Lay‑use kits for saliva or stool collection for SARS-CoV‑2 or occult blood testing → Class A
Rule 6 – Updated Example
The example for Influenza A/B now refers to a highly virulent strain rather than a non‑pandemic one.
Classification of Key Diagnostic Technologies in MDCG 2020-16 Rev.3
Next‑Generation Sequencing (NGS)
Rev.3 highlights the role of NGS across several rules:
- Rule 3(f) (Companion Diagnostics) – NGS identifies variants linked to therapeutic response.
- Rule 3(h) (Cancer Diagnostics) – Supports cancer staging and genomic profiling.
- Rule 5(a)–(b) (General Laboratory Use) – Includes library prep reagents, PCR thermocyclers, NGS sequencers, and other instruments essential for genetic analysis.
Companion Diagnostics (CDx)
Under Rule 3(f):
CDx devices are essential for the safe and effective use of specific medicinal products. They are used to:
- Identify suitable patients for targeted therapies
- Detect risks of adverse reactions
- Support treatment decisions before or during therapy
Examples provided in Rev.3 include:
- KRAS/NRAS variant detection for colorectal cancer
- PD‑L1 IHC tests for immunotherapy selection
- NGS‑based CDx for multi‑gene therapy selection
A decision flowchart in Annex II helps manufacturers determine whether an IVD qualifies as a CDx.
Self‑Testing Devices (Rule 4(a))
Self‑testing IVDs must be usable by laypersons without compromising analytical performance. Rev.3 emphasizes:
- Ease of use
- Safety
- Minimised risk of misuse
Near‑Patient Testing (NPT) Devices (Rule 4(b))
NPT devices are designed for rapid clinical decision-making in point‑of‑care settings.
Rev.3 ensures clear differentiation between self‑testing and near‑patient testing based on user type, setting, and intended use.
MDCG 2020-16 Rev.3 classification rules provide crucial clarifications that support more consistent application of the IVDR. By refining definitions, expanding examples, and clarifying rules for CDx, NGS, self‑testing, and near‑patient testing, the guidance helps manufacturers classify devices accurately and reduce regulatory uncertainty.
