IVDR Date of Application

As of today:

• Any new IVD devices must be CE Marked to the IVDR prior to placing it on the European market.
• Class A non-sterile IVD devices require IVDR CE Marking in order to be placed on the market, i.e., legacy device status does not apply to Class A non-sterile IVDs

A transition period is granted for all other IVD devices. Certain conditions apply. Please review IVDR Article 110 for the full list of transitional requirements.