The article highlights the key points related to the regulatory status of in vitro diagnostic medical devices under the existing legal framework.
Table of content
The Medical Device Coordination Group (MDCG) has published a guidance document dedicated to the qualification of in vitro diagnostic medical devices. The document provides a general overview of the applicable regulatory requirements set forth under the relevant legislation, as well as additional recommendations and clarifications to be taken into consideration by medical device manufacturers and other parties involved in order to ensure compliance.
At the same time, provisions of the guidance are non-binding in their legal nature, nor are they intended to introduce new rules or impose new obligations, and could also be subject to changes, should such changes be reasonably necessary to reflect corresponding amendments to the underlying regulations.
Introduction
The Medical Device Coordination Group, under Article 103 of Regulation (EU) 2017/745, released the MDCG 2024-11 document to clarify the qualification of products under Regulation 2017/746 (IVDR). This guidance outlines the criteria for determining whether a product qualifies as an in vitro diagnostic medical device (IVD) or an accessory to an IVD. It focuses on definitions, intended purposes, and distinctions between IVDR and Regulation (EU) 2017/745 on medical devices (MDR)
The guidance is primarily intended to:
- Define which products fall under the IVDR.
- Differentiate IVDs from medical devices governed by the MDR.
- Provide illustrative examples of IVDs and accessories, offering manufacturers a reference to classify their products.
The document emphasizes that qualification is based on the manufacturer’s intended purpose for the product, as specified in its labeling or promotional materials.
General Principles of Qualification
According to the guidance, the process of determining whether a product is within the IVDR’s scope is based on the definitions and provisions in Articles 1 and 2 of the regulation.
Medical Device (MDR, Article 2(1)): An article intended for medical purposes, including diagnosis, prevention, monitoring, or treatment of diseases or injuries in humans. Notably, these devices do not achieve their primary function through pharmacological, immunological, or metabolic means.
In Vitro Diagnostic Medical Device (IVDR, Article 2(2)): A device intended for in vitro examination of human-derived specimens to provide medical information on:
- Physiological or pathological processes.
- Congenital impairments.
- Predisposition to diseases.
- Safety and compatibility with recipients.
- Prediction of treatment responses.
- Monitoring therapeutic measures.
Essential Characteristics of an IVD
As further explained by the MDCG, the core characteristics of an IVD include:
- Device Type: Can be reagents, kits, calibrators, control materials, instruments, software, or systems.
- In Vitro Use: Examination of human-derived specimens outside the body. Devices involving environmental samples, veterinary diagnostics, or in vivo procedures are excluded.
- Purpose: Must provide information for medical purposes such as diagnosis, monitoring, or prediction of health states.
Examples would include devices for detecting pregnancy, monitoring blood glucose, or screening for congenital diseases.
At the same time, it is important to mention that products without medical purposes, such as ancestry or lifestyle tests, are excluded from the IVDR.
Criteria for Qualification
The guidance additionally emphasizes that the qualification process depends on the product’s intended purpose:
- If the intended purpose involves providing medical information per Article 2(2) of the IVDR, the product qualifies as an IVD.
- Products with multiple purposes, at least one of which is medical, must comply with the IVDR.
For example:
- Medical Purposes: A self-test for HIV or a device for genetic screening of congenital impairments.
- Non-Medical Purposes: Tests for determining ancestry or recreational genetic profiling.
Furthermore, it is stated that a product cannot qualify as an IVD solely based on labeling or promotional claims.
Demarcation Between IVDR and MDR
The guidance highlights the critical need to distinguish between IVDs under the IVDR and devices covered by the MDR:
- MDR governs medical devices used in vivo or for purposes beyond diagnostic testing of specimens.
- IVDR applies exclusively to products used in vitro for examining human specimens.
Examples of non-IVD products:
– Environmental diagnostic tools, such as devices detecting Lyme disease pathogens in ticks.
– Veterinary diagnostic tools.
Regulatory Implications
Manufacturers must conduct a thorough qualification process to ensure their products align with IVDR requirements before market entry.
Key steps include:
- Defining the product’s intended purpose based on supplied data.
- Evaluating whether the purpose aligns with Article 2(2) of the IVDR.
Failure to meet IVDR criteria could lead to reclassification under MDR or exclusion from both regulations.
Conclusion
In summary, the present guidance provides manufacturers with comprehensive guidance to determine whether a product qualifies as an IVD under IVDR. Focusing on intended purposes and specific use cases, this document is intended to assist with ensuring regulatory compliance and appropriate market placement of diagnostic devices. However, each qualification remains subject to case-by-case evaluation. Manufacturers are encouraged to consult supplementary materials, such as the Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices, for further guidance.
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