Regulatory Compliance and the Meaning of “Placing on the Market”

The concepts of “making available” and “placing on the market” are fundamental to EU market access and it is critical that manufacturers clearly understand these definitions as they are directly related not just to EU market access, but also in the assessment of product regulatory compliance including economic operator obligations.  

Prior to the establishment of the New Legislation Framework (NLF) under Regulation (EC) 765/2008 and Decision No 768/2008EC, there was an emphasis on the moment when product was first made available on the EU market. Although the NLF’s focus was originally on ensuring that a product reached the market, more importance is now given to what happens to a product once it becomes available (particularly within the context of market surveillance).

The MDR/IVDR establishes the following definitions, each aligned with the NLF: 

‘making available on the market’ means any supply of a device, other than [an investigational device (MDR) / a device for performance study (IVDR)], 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. 

‘placing on the market’ means the first making available of a device, other than [an investigational device (MDR) / a device for performance study (IVDR)], on the Union market. 

The MDR/IVDR states that a device may be placed on the market (or put into service) only if it complies with the corresponding regulation when duly supplied and properly installed, maintained and used in accordance with its intended purpose. As stated in the Blue Guide, applicable EU harmonization legislation applies: 

• • • When it is placed on the market 
    • During any subsequent making available until the product reaches the end user 
    • When it is still in the distribution chain as long as it is a new product (this would include ‘refurbished’ product) 

The manufacturer or importer should place on the market, with any subsequent supply in the supply chain (distributor to distributor) being defined as making available. It is also important to understand that placing a product on the market does not require the physical handover of the product, but it does require that the manufacturing stage has been completed.  

As also stated in the Blue Guide, EU harmonization legislation applies to all forms of supply, including distance selling and selling through electronic means (covered under Article 6 of the MDR/IVDR). Manufacturers should identify those products which are being offered/targeted at end users in the EU and conduct a case-by-case analysis. In the EU, an offer for sale is considered to be targeted at end users if an economic operator directs, by any means, its activities to an EU Member State.

Lastly, the concept of “making available on the market” continues to be of critical importance for devices CE marked under the MDD/IVDD and subject to the transitional provisions of the respective regulations, as clear deadlines have been established covering when such devices may continue to be made available. Relevant guidance on so-called “legacy devices” is available in MDCG 2021-25 and MDCG 2022-8. 

MedEnvoy offers EU Importer services

Find out more on our services here: EU Importer Service

Should you have any questions regarding our services, get in touch.