Module 16 2022

9/2/2022

Important Definitions – Special Considerations for SaMD and Apps

2.4. Making available and placing on the market in case of distance and online sales

Products offered for sale online or through other means of distance sales are deemed to be made available on the Union market if the offer is targeted at end users in the Union (58). The legal consequence is that, if the offer is targeted at end users in the Union, products offered for sale online or through other means of distance sales need to comply with all applicable EU rules and can be subject to checks by market surveillance authorities pursuant to Regulation (EU) 2019/1020. If products are sold online, it is required that the CE marking and any required warnings according to applicable legislation are indicated in that website and visible before the end user is carrying out the purchase.

The Organisation for Professionals in Regulatory Affairs

9/2/2022

25

25

Important Definitions – Special Considerations for SaMD and Apps 2.4. Making available and placing on the market in case of distance and online sales Online or distance selling may be a specific manner of making products available but it does not necessarily constitute the first making available of the product on the Union market (i.e. the placing on the market). The actual placing on the market of these products may differ for each individual product, depending on the specific distribution chain, for example: The distance sale or online offer may refer to products that have already been placed on the Union market. This is the case where the EU manufacturer or an importer has already placed them on the Union market before they were offered for sale online or through other means of distance selling. Some products offered online or through other means of distance selling to end users in the Union are transferred first to fulfilment service providers located in the EU to guarantee their swift delivery to EU end users. Accordingly, products stored by such fulfilment service providers and released for free circulation are considered to have been supplied for distribution, consumption or use on the EU market and thus placed on the EU market. When an online operator uses a fulfilment service provider in this manner, by shipping the products to the fulfilment house in the EU, the products are in the distribution phase of the supply chain (61). These products are considered placed on the market at the time they are released for free circulation. Some products outside the EU can be bought directly by end-users in the EU online or through other means of distance sales. Although these products are deemed to be made available in the Union prior to any transaction for the purposes of checks by market surveillance authorities pursuant to Regulation (EU) 2019/1020, they are placed on the market at the moment an order by an end user has been placed and confirmed for a specific product already manufactured and subject of the transaction, and ready to be shipped.

The Organisation for Professionals in Regulatory Affairs

9/2/2022

26

26