On October 8, 2024, the European Commission’s Medical Device Coordination Group (MDCG) announced guidance MDCG 2024-11 regarding the qualification of in vitro diagnostic medical devices (IVDs).
To achieve qualification as an IVD or an accessory, a product must meet the criteria defined in Article 2(2) or Article 2(4) of the IVDR. The MDCG 2024-11 guidance clarifies the scope of products covered under Regulation 2017/746 and explains the qualification process for IVDs and their accessories.
The Guidance addresses topics including the following.
- specimen receptacles and products used for the collection of specimens
- devices not involving specimens
- products for general laboratory use
- products for research use only
- combinations of products placed on the market together (Kit)
- Calibrators and control materials
- Software
- etc.
For software, it is included in the IVDR scope according to Article 2(2). Detailed guidance (MDCG 2019-11) on IVDR software qualification can be accessed on the European Commission website.
Please refer to the attached document below.
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