Placing on the market communication
Any natural or legal person who makes a class IIa, IIb or III product available for distribution and/or use in Spanish territory for the first time shall make a communication to the Spanish Agency for Medicines and Medical Devices (AEMPS), at the time such making available on the market.
The AEMPS will keep an updated register of all of them. Likewise, any natural or legal person who markets medical devices must keep a register of the products they make available in Spanish territory, including at least:
- Trade name of the product.
- The model.
- Serial or lot number.
- Date of supply.
- Customer identification.
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