The ability to sell a device in the EU with an expired CE certificate depends on the following factors: The applicable regulation, i.e., if the device is a ‘legacy’ product (under the MDD/IVDD/AIMDD) or certified under the MDR and IVDR; and, Where in the supply chain the product was when the certificate expired, i.e., if it is being ‘placed on the market’* or if it is being ‘made available’.** ‘Placed on the market’ Legacy Device (valid MDD/IVDD/AIMDD CE Certificate): Legacy devices with an expired CE Certificate are able to be ‘placed on the market’ through the below transitional deadlines, per Regulation 2023/607. This regulation came into force on 20 March 2023, automatically extending the validity of CE certificates for legacy devices. To be eligible for these transition timelines, the device and manufacturer must meet the specific criteria established in the regulation. Read more about the requirements here. Class I (sterile/measuring), Class IIa, Class IIb non-implantable – 31 December 2028 Class IIb implantable & Class III – 31 December 2027 (except sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors) MDR/IVDR Device: MDR/IVDR devices with an expired CE Certificate cannot be ‘placed on the market’ - the CE certificate must be valid at the time the device is ‘placed on the market’. ‘Made Available on the Market’ Legacy Device (valid MDD/IVDD/AIMDD CE Certificate): Legacy Devices ‘placed on the market’ in compliance with the amended deadlines and criteria of Regulation 2023/607 may continue to be ‘made available on the market’ or ‘put into service’ without any limitation in time’ except the device’s shelf-life or expiry date (see: Q&A on practical aspects related to the implementation of Regulation (EU) 2023/607). MDR/IVDR Device: MDR/IVDR devices that were ‘placed on the market’ in the period where the certificate was valid and was in conformity with all applicable legislation, can further be ‘made available’ and ‘put into service’ after the CE certificate expires. Definitions *Placing on the Market (MDR Article 2(28)): the first making available of a device, other than an investigational device, on the Union market. The Blue Guide further explains that devices that are manufactured (i.e. ready to ship) and have an agreement in place for purchase with a local importer are considered ‘placed on market’.  The Blue Guide further explains that ‘Any subsequent operation, for instance, from a distributor to distributor or from a distributor to an end-user is defined as making available’. Read more about the definition of ‘placing a product on the marketing’ in the EU here. **Making available on the market (Article 2(27)): any supply of a device, other than an investigational device, for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge. ***Putting into service (MDR Article 2 (29)): The stage at which a device, other than an investigational device, has been made available to the final user as being ready for use on the Union market for the first time for its intended purpose.