The Medical Device Coordination Group (MDCG) has updated its guidance on the classification of in vitro diagnostic medical devices (IVDs) under Regulation (EU) 2017/746 (IVDR).
The guidance provides clarification on the application of the classification rules set out in Annex VIII of the IVDR and is intended to support the consistent classification of IVDs across the European Union. The guidance has been developed by an expert group comprising representatives from EU Member State Competent Authorities, the European Commission, notified bodies, and industry.
The document is primarily intended to support manufacturers, notified bodies, and health institutions when determining the appropriate classification of an IVD before it is placed on the market, made available on the market, or put into service in the EU. It can also assist regulators and other stakeholders when assessing the classification assigned by a manufacturer or health institution.
The guidance also covers certain diagnostic or information society services provided to patients in the EU, as well as IVDs made available through distance sales, where applicable.
Key Update: Rule 7
Among the latest changes is a clarification of the rationale supporting the application of Rule 7, together with revisions to the examples provided under Rule 7.
These updates are intended to provide greater clarity when applying the classification criteria and support a more consistent approach to determining the appropriate risk class of IVDs.
Manufacturers should continue to read the classification guidance in conjunction with the IVDR, as the guidance is intended to explain and support the application of the regulatory requirements rather than replace the provisions of the Regulation.
The updated guidance document can be accessed using the following link
