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Regulatory Focus™ > News Articles > 2020 > 11 > MDCG releases long-awaited IVD classification guidance

MDCG releases long-awaited IVD classification guidance

Posted 13 November 2020 | By Michael Mezher 

MDCG releases long-awaited IVD classification guidance

The European Commission’s Medical Device Coordination Group (MDCG) on Friday released its much-anticipated guidance on the classification of in vitro diagnostics (IVDs) under the In Vitro Diagnostic Regulation (IVDR).
The nearly 50-page guidance is intended to explain how IVDs should be classified to manufacturers, notified bodies and healthcare providers before they are placed on the EU market and is seen as critical to industry’s ability to accurately classify diagnostics under the IVDR’s risk-based classification system.
Under IVDR, diagnostics are divided into four classes, A, B, C and D, from lowest- to highest-risk, based on their intended purpose and their inherent risks, with certain requirements applying only to the higher risk classes.
“In particular, the conformity assessment route is highly dependent on classification, which is reflected in concepts such as conformity assessments scrutiny of class D devices (Article 50), the involvement of the European Union reference laboratories for high-risk devices (Article 100) and a consultation with a national medicines agency or the European Medicines Agency (EMA) for companion diagnostics (Article 48(3)),” the guidance states.
The guidance explains that the classification of an IVD is driven by its intended purpose, which itself is specified by the manufacturer in labeling, instructions for use (IFU), promotional/sales materials, statements and in the performance evaluation.
“It is therefore important that the manufacturer clearly indicates the purpose for which the device is intended,” the guidance states. If a diagnostic may be used in ways that would result in a higher risk classification, MDCG says the manufacturer should include a limitation of use in the IFU and technical documentation.
Similarly, if a diagnostic is specifically intended for a purpose laid out in a particular classification rule, MDCG says that purpose should be clearly stated. “Where several classification rules or sub-rules may apply, the intended purpose of the device and its claims, shall be sufficiently specified to enable a clear attribution of the class. Ambiguous claims may lead to higher classification,” the guidance states. As an example, the guidance explains that a diagnostic to screen blood and tissue donations for syphilis would be considered class D, while a device intended to diagnose syphilis infection would be considered class C.
The bulk of the guidance is dedicated to explaining seven rules for determining the classification of IVDs. For instance, Rule 1 lays out the parameters for three intended purposes that would prompt a diagnostic to fall under class D, while Rule 3 covers an expansive range of devices that would be considered class C.
The guidance also provides examples of diagnostics under each rule and includes an annex that gives examples of how IVDs used in combination should be classified.


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