Placing on the Market
Placing on the market is the EU legal term for the first supply of a product on the EU internal market. It is a one-time event that occurs when a product is first transferred by a manufacturer or importer to a distributor or end user in the EU.
Key distinctions:
- Placing on the market ≠ making available on the market: the latter describes every subsequent transfer after initial placing
- Placing on the market ≠ putting into service: putting into service describes the first use by the end user
Legal obligations at the time of placing on the market:
- The product must comply with all applicable EU requirements (CE marking, EU DoC, technical documentation)
- MDR, PPE Regulation, or other applicable regulation requirements must be fully met
- For medical devices: UDI labelling and EUDAMED registration must be complete
Manufacturers outside the EU may not place products directly on the EU market - they require an EU Authorised Representative or importer.
Frequently asked questions
What is the difference between placing on the market and making available on the market?
Placing on the market is a one-time event - the first supply to a distributor or user in the EU. Making available on the market describes every subsequent step in the supply chain (resale, distribution). Both terms are defined in MDR Art. 2.
Who is legally responsible for placing on the market?
The manufacturer (if EU-based) or the EU Authorised Representative (if the manufacturer is outside the EU) bears responsibility. The importer takes on additional obligations when importing from third countries.
Can a product be modified after it has been placed on the market?
Substantial modifications to an already-placed product may require a new conformity assessment and re-placing on the market. Cosmetic or non-safety-relevant changes are generally exempt.