The final article of the cycle highlights the key points related to certain specific product categories, outlining the most important aspects to be taken into consideration.
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.
Products for Research Use Only
First of all, it is mentioned that the IVDR explicitly excludes Research Use Only (RUO) products from its scope (Recital 7, Article 1(3)(a)). Manufacturers of RUO products must ensure these are not marketed or intended for any medical purpose as defined under Article 2(2) of the IVDR.
Combinations of Products
In Vitro Diagnostic (IVD) Kits:
An IVD kit refers to a set of components packaged together and intended for a specific in vitro diagnostic examination. According to Article 2(11), the kit itself qualifies as an IVD, provided the set’s intended purpose falls under the IVD definition.
Key points:
- IVD kits must bear the CE mark on the outer packaging and meet IVDR requirements for information supplied by the manufacturer.
- Kits may include:
- IVDs or accessories (individually CE-marked or not).
- Medical devices (e.g., swabs, lancets) that comply with MDR.
- Other components (e.g., general laboratory items or food products).
Exclusions for this rule would be that IVD kits cannot include medicinal products. For instance, a co-packaged product with labeled urea (a medicinal product) for Helicobacter pylori detection cannot qualify as an IVD kit. Instead, each product must adhere to its respective legislation.
Distinction from Procedure Packs:
Under Article 2(10) MDR, a procedure pack refers to a set of products packaged together for a specific medical purpose. The intended purpose determines whether the combination qualifies as an IVD kit under IVDR or a procedure pack under MDR.
Devices Incorporating Medical Devices
If an IVD incorporates a medical device as an integral part, the MDR applies to the medical device, and the IVDR applies to the IVD component. Integral products are physically combined into a single object and classified accordingly.
Examples of integral products would be:
- Saliva suction devices containing reagents (medical devices).
- Swabs with integrated reagents (medical devices).
- In vivo glucose monitors with in vitro measurement components (medical devices).
Non-integral products, such as detachable medical devices packaged with IVDs, are classified separately and must comply with both MDR and IVDR.
Calibrators and Control Materials
Per Article 2(2), calibrators (measurement reference materials) and control materials (used to verify device performance) qualify as IVDs if they meet the definition in Article 2(55) and (56). However, externally certified reference materials and External Quality Assessment (EQA) materials are not IVDs unless repurposed for diagnostic use.
In such cases, EQA organizations must comply with IVDR requirements and obtain CE marking.
Software
Standalone software can qualify as an IVD under Article 2(2) if it provides diagnostic information based on results from other IVDs. For further details, manufacturers should consult MDCG 2019-11 guidance.
Microbiological Culture Media
Under the general rule, culture media intended to provide diagnostic information on human specimens can qualify as IVDs if they meet the IVDR’s requirements.
The manufacturer must specify:
- The medical purpose of the media.
- The type of specimen required (e.g., blood, urine).
Examples:
- Qualified IVD: MacConkey Agar with a selection agent for identifying microorganisms.
- Non-Qualified: General-purpose culture media without a diagnostic intent.
Stains
Stains for histology, cytology, and microbiology may qualify as IVDs if intended for diagnostic purposes. Manufacturers must provide details about the stain’s medical utility, characteristics, and required specimen types.
Examples are:
- Qualified IVD: Ziehl-Neelsen stain for diagnostic purposes.
- Non-Qualified: Stains without medical intent.
Tests for Manufacturing Process Control
Tests used solely to monitor the manufacturing process of products, such as medicinal products, are not considered IVDs, as they lack a medical purpose.
Example (non-IVD): a test for detecting infectious agents in plasma used for advanced therapy medicinal products.
Tests for Biological or Chemical Warfare Agents
Tests for detecting biological or chemical warfare agents in environmental samples do not qualify as IVDs. However, if such tests also examine human specimens for medical purposes, they qualify as IVDs under the IVDR.
Tests for Law Enforcement
Tests intended solely for law enforcement (e.g., paternity tests, drug abuse detection) are not IVDs. However, if the test examines human specimens with a medical purpose, the IVDR applies.
Relation with Biocidal Products Regulation
Products governed by the IVDR are excluded from Regulation (EU) No 528/2012 on biocidal products. However, if a biocidal product serves purposes outside the IVDR scope, the biocides regulation applies to those additional purposes.
Conclusion
In summary, the guidance offers clarity on various product categories, from research-use-only items to complex combinations of IVDs and medical devices. Manufacturers must carefully evaluate the intended purposes and configurations of their products to ensure compliance with IVDR or other applicable regulations.
How Can RegDesk Help?
RegDesk is an AI-powered Regulatory Information Management System that provides medical device companies with regulatory intelligence for over 120 markets worldwide. It can help you prepare and publish global applications, manage standards, run change assessments, and obtain real-time alerts on regulatory changes through a centralized platform. Global expansion has never been this simple.
