The European Commission’s (EC) Medical Device Coordination Group (MDCG) has released guidance on the classification of in-vitro diagnostic (IVD) medical devices under the incoming EU In-vitro Diagnostic Regulation (IVDR).
The guidance addresses how IVDs should be classified by device manufacturers, notified bodies (NB) and healthcare providers before being placed on the EU market, via the IVDR’s risk-based classification system.
Under IVDR, IVD’s will be divided into four classes: A (lowest risk), B, C, D (highest risk). The guidance explains that these risk classes are based on the devices intended purpose and characteristic risks. These should be specified in the product’s labelling, instructions for use (IFU), performance evaluations and promotional material. Manufacturers should include limitations for use in the IFU and any technical documentation.
According to the guidance, IVD classification procedure will be broken down into seven rules. Each rule relates to classification of specific devices under specific classes. The guidance also provides some examples and case studies to aid manufacturers.
Click here to access the full guidance.