The Medical Device Coordination Group (MDCG) has released a detailed guidance document titled "Qualification of In Vitro Diagnostic Medical Devices (IVDs)." This guidance provides essential information to manufacturers, healthcare providers, and regulators on the criteria and steps necessary for qualifying a medical product as an In Vitro Diagnostic Medical Device under the EU In Vitro Diagnostic Regulation (IVDR).
The Medical Device Coordination Group (MDCG) is an expert group established under the European Medical Devices Regulation (MDR) 2017/745 and the In Vitro Diagnostic Medical Devices Regulation (IVDR) 2017/746. The MDCG guides to ensure the uniform application of medical device regulations across the European Union (EU) and supports the European Commission and member states in implementing these regulations. Its role is critical for the smooth functioning of the regulatory framework concerning medical devices and in vitro diagnostics within the EU.
In short, an IVD is defined as any medical device that is intended for the examination of specimens derived from the human body to provide information on:
Physiological or pathological processes
Congenital abnormalities
Safety and compatibility of potential donors or recipients
Monitoring therapeutic measures
The document provides detailed examples and explanations to help determine whether a product meets these criteria.
An IVD can be a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, piece of equipment, software or system.
Products without a medical purpose (as outlined in Article 2(2) IVDR) are not IVDs. Examples: tests to determine ancestry, to find relatives, or to reveal ethnic origins, or tests intended to be used for sport, wellbeing and lifestyle purposes
This guidance clarifies what products fall within the scope of Regulation 2017/746 on in vitro diagnostic medical devices (IVDR) - also called 'qualification' as an in vitro diagnostic medical device (IVD) or accessory to an IVD. A product must meet the criteria in Art 2(2) or Art 2(4) of the IVDR to qualify as an IVD or an accessory to an IVD. Qualification depends on the manufacturer's description of the intended use.
The qualification of a device as an IVD requires careful evaluation against the IVDR’s legal definition. This involves considering the intended purpose of the device, mode of operation, and the nature of the analyte being detected or measured.
The guidance explains the risk-based classification system, which ranges from Class A (low risk) to Class D (high risk), based on factors such as:
The medical importance of the results provided by the test
The impact of erroneous results on patients and public health
The intended use and user population
The MDCG’s guidance on the qualification of in vitro diagnostic medical devices is a critical resource for ensuring that medical products are correctly classified and meet the regulatory standards set by the IVDR. Proper qualification and classification help safeguard public health by ensuring that diagnostic devices are safe, reliable, and effective for their intended use.
For full details, refer to the complete guidance document available here.
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