Devices being placed on the market for the first time in the EU must be CE Marked or have been granted a derogation by an EU Competent Authority, whether they are for donation or for sale (see definition of ‘placed on the market’ in the EU here). Each EU Competent Authority can only grant a derogation for its specific market, so manufacturers must seek individual derogations for each EU country where they would like to place their product on the market without CE Marking. Once the device has been placed on the market, it can be further resold or donated. The MDR and IVDR only apply to medical devices being placed on the market for the first time. The EU Blue Guide 2022 clarifies that second-hand products from third countries placed on the market for the first time must comply with the EU legislation (MDR and IVDR). There is no medical device legislation that specifically covers devices for resale or reuse, including providing devices second-hand for donation. Therefore, if a device was compliant at the time it was placed on the market, it can be further sold or donated for reuse. That being said, those further resold medical devices are still required to be safe and within their effective use period.