MDCG Guidance Clarifies IVDR Product Classification and Scope

Despite over a year having passed since publication of Version 3 of the Manual on borderline and classification for medical devices under Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices, it is in fact MDCG 2024-1 Guidance on  qualification of in vitro diagnostic medical devices (published in October 2024) that finally provides IVDR-relevant guidance aligned with guidance previously provided in MEDDEV 2.14/1 revision 2 (January 2012) under the IVDD.

For those manufacturers developing/ marketing CE marked in vitro diagnostic medical devices (IVDs) for the first time under the IVDR or other products for which they are unsure whether the IVDR applies, this guidance provides valuable insight and examples for scenarios frequently encountered in the IVD world.

Key insights the MDCG guidance for IVDR classification clarifies on:

• • Accessories
  • Specimen receptacles and products used for the collection of specimens
  • Products for general laboratory use
  • Research Use Only (RUO) products
  • Combinations of products placed in the market together (e.g. IVD kits, and IVDs incorporating a medical device as an integral part)
  • Calibrators and control materials vs. External Quality Assessment (EQA) scheme materials
  • Microbiological culture media and stains
  • Tests intended for specific purposes (e.g. biological or chemical warfare, law enforcement)
  • Relation with Regulation (EU) 528/2012 on biocidal products (as many IVD reagents / buffer solutions contain biocidal products to address the risk of false positive / false negative test results)

As was the case with MEDDEV 2.14/1 revision 2, MDCG 2024-11 in particular provides critical guidance for manufacturers to determine whether their products are IVDs or medical devices based upon the manner in which specimens are collected. Of note, invasive (within the meaning of the MDR) specimen collection devices or those which are directly applied to the human body for the purpose of obtaining a specimen must not be considered accessories to IVDs. Such products are considered to be medical devices within the scope of the MDR. For example, continuous blood glucose monitoring sensors applied to a patient’s arm would continue to be considered medical devices and not IVDs.

Additionally, manufacturers of drug testing products accustomed to these being considered as IVDs under the US FDA regulatory framework should note that MDCG 2014-11 continues to consider these products as not being IVDs is they are only intended to be used in the course of law enforcement or other non-medical purposes (e.g. detecting abuse of alcohol or drugs). However, should such products have medical purposes in addition to these non-medical purposes, they would be considered as IVDs.

Aside from updating references to requirements under the IVDD with corresponding requirements under the IVDR (with expanded examples) and layout changes, MDCG 2024-1 provides few significant changes to the guidance previously provided under MEDDEV 2.14/1 revision 2.

Other changes comprise of:

• • Addition of software-related guidance, comprising cross-reference to MDCG 2019-11 on the qualification of IVD software
  • Addition of guidance for tests intended to be used in manufacturing process control (i.e. not qualified as IVDs)
  • Update of relation with Regulation (EU) 528/2012 instead of Directive 98/8/EC
  • Removal of classification guidance as this is established in standalone guidance under MDCG 2020-16

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If you or your organization have any questions regarding the MDCG guidance for IVDR product classification and scope, require an EU Authorized Representative, or need support in IVD design and development, contact us so our regulatory team can assist you. 

Learn how MedEnvoy can assist you:

• • EU Authorized Representative
  • EU Regulatory Importer
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