Page Last Reviewed: 2 January 2024
|Products must be ready for distribution (i.e., must already be manufactured)
|Transfer of Ownership must be complete
|Deadline for legacy devices to be ‘placed on the market’
|Varies by market, regulation, and classification.
*For the EU & UK, transfer of ownership can be an agreement to purchase executed between manufacturer & local importer/customer.
**For Switzerland (CH), the transfer of ownership for a non-Swiss manufacturer’s products is between the Swiss Importer and the Swiss customer, and not between the foreign manufacturer and the Swiss Importer. See Switzerland section below for more details.
The Blue Guide defines ‘placing on the market’ as:
“A product is placed on the market when it is made available for the first time on the Union market. This operation should be done by the manufacturer or by an importer.
When a manufacturer or an importer supplies a product to a distributor or an end-user for the first time, the operation is always labelled in legal terms as ‘placing on the market’. Any subsequent operation, for instance, from a distributor to distributor or from a distributor to an end-user is defined as making available.“
It further states:
“Placing a product on the market requires an offer or an agreement (written or verbal) between two or more legal or natural persons for the transfer of ownership, possession or any other property right concerning the product in question; it requires that the manufacturing stage has been completed.
This transfer could be for payment or free of charge. It does not require the physical handover of the product.
Sometimes products are manufactured following the placing of an order. An offer or agreement concluded before the stage of manufacture has been finalised cannot be considered as placing on the market (e.g. an offer to manufacture a product according to certain specifications agreed by the parties to the contract, where the product will only be manufactured and delivered at a later stage).“
What does this mean in practical terms?
The EU Commission’s “Notice to Stakeholders: Withdrawal of the United Kingdom and EU Rules in the Field of Industrial Products” reiterates the Blue Guide. While this Notice was drafted specifically regarding ‘Brexit’, the information can be applied to other situations in which ‘placing on the market’ is key, including legislation cutoff dates.
Importer requirements under Article 13 of the MDR/IVDR. Plus, what are the manufacturer’s obligations to/from the importer and how are direct sales handled?
For more information on this topic, please refer to: MDR/IVDR Guidance for Importers and Distributors
The definition can be found on the MHRA’s website: Placing Manufactured Goods on the Market in Great Britain
The MHRA also issued an unambiguously titled document: Notice – Definition of ‘placing on the market’ before and after the UK leaves the EU, if there’s no Brexit deal
UKCA Marking deadlines; UKCA versus CE Marking technical file and labeling differences; where to download the symbol; and more.
Per Swissmedic’s FAQ titled Stock Items:
The relevant requirements for devices must be fulfilled at the time of placing on the market (definition according to Art. 4 para. 1 let. b MedDO). Devices in the manufacturer’s warehouse are not yet placed on the market.
Consequence: “Stock sell-off”, e.g. after expiry or withdrawal of the designated body’s certificate, is not possible.
Devices that were imported or already in the distributor’s warehouse before the new regulation entered into force (26 May 2021) are considered to be placed on the market in the European context according to the provisions of the old legislative and can continue to be made available on the market (Art. 101 para. 3 MedDO; devices compliant with the old legislation may be made available until 26 May 2025 at the latest). The importer or CH-authorised representative does not need to be stated retrospectively.
Devices imported / in the warehouse after the new regulation entered into force (26 May 2021): Transitional provisions apply to the indication of the CH-authorised representative and the CH-importer (for more information see Chapter 6 of the Information sheet, Obligations Economic Operators).
For more information on the Swiss Authorized Representative deadlines, please read: Switzerland Authorized Representative