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October 2024
The Medical Device Coordination Group (MDCG) has released updated guidance on the qualification criteria for products under Regulation 2017/746 on In Vitro Diagnostic Medical Devices (IVDR). This guidance is designed to assist manufacturers in determining whether their products fall under the scope of the IVDR, and it outlines key definitions, essential characteristics, and qualification topics.
Key Highlights of the Guidance:
Definitions and Essential Characteristics:
The guide provides clear definitions and characteristics to help manufacturers understand the scope of the IVDR.
Key Qualification Topics:
The guidance covers various areas critical to product classification, including:
The relationship with EU Regulation No 528/2012 on biocidal products.
Qualification of software as an IVD.
Qualification of microbiological culture media as IVDs.
Qualifications of stains used in histology, cytology, and microbiology tests.
Examples and Clarifications:
The document provides real-world examples and further clarification to help manufacturers navigate the complex qualification process for IVD products.
This guidance helps ensure manufacturers understand their obligations under the IVDR, fostering compliance and facilitating the regulatory process for IVDs in the EU.
Region: EU Harmonized (27 Markets)
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