EU Releases New Guidance on Qualification of In Vitro Diagnostic Medical Devices

In October 2024, the European Union (EU) published a new guidance document to clarify the qualification of products under Regulation (EU) 2017/746 on in vitro diagnostic medical devices (MDCG 2024-11).

Such guidance is endorsed by the Medical Device Coordination Group (MDCG) that is composed of representatives of all Member States and is chaired by a representative of the European Commission. It is not a European Commission document and cannot be regarded as reflecting the official position of the European Commission. Nonetheless it is intended to assist stakeholders in applying the Regulation (EU MDR) 2017/745 on medical devices and Regulation (EU IVDR) 2017/746 on in vitro diagnostic medical devices.

The new guidance aims to help manufacturers determine if their products fall under the definition of in vitro diagnostic medical devices (IVDs) or accessories to IVDs, as outlined in Articles 2(2) and 2(4) of the IVDR. The qualification of a product depends primarily on the intended purpose specified by the manufacturer. The guidance discusses the following specific IVD products: 

• Accessories
• Specimen receptacles and products used for the collection of specimens
• Devices where no specimen is involved
• Products for general laboratory use
• Products for research use only
• Combinations of products placed on the market together
• Calibrators and control materials
• Software
• Microbiological culture media
• Stains
• Tests intended to be used in manufacturing process control
• Tests intended to be used in the context of biological or chemical warfare
• Tests to be used in law enforcement
• Relation with Regulation (EU) No 528/2012 on biocidal products

This guidance marks the fourth document released by the Medical Device Coordination Group (MDCG) in 2024, continuing their ongoing efforts to support manufacturers in navigating IVDR compliance. Other expected guidances for 2024 include:

• Template and guidance for Safety reporting in performance studies under IVDR
• Guidance on IVD borderline issues
• Analysis of IVDR in urgent health crisis scenarios
• and much more.

As the regulatory landscape for IVDs evolves, these guidance documents will help manufacturers understand and apply IVDR requirements to their products.

ECI closely monitors regulatory updates to ensure our clients remain compliant and prepared for upcoming changes. The new IVDR guidance highlights the importance of understanding product qualification and staying proactive in meeting regulatory requirements.

Contact us to ensure your IVD products meet EU regulations. Our team is ready to help you navigate the complexities of IVDR and maintain your products compliance with the latest standards.

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