Registration of persons responsible for placing medical devices on the market

• Manufacturers of medical devices established in Spain, placing class I products on the market
• The manufacturers of custom-made medical devices, of any classification.
  • If they are established in Spain, they must communicate their introduction into the European market, regardless of the country in which they are marketed.
  • If they are established outside Spain, they should only communicate medical devices as they enter the Spanish market.
• The Authorised Representatives of the manufacturers of custom-made medical devices of any kind, established in Spain, must communicate their introduction into the market, regardless of the country in which it is marketed.
• Manufacturers of medical devices for diagnosisin vitroestablished in Spain, to market this type of product on their own behalf.
• Authorized representatives established in Spain who place on the market or market the products mentioned in the previous sections.
• Medical device binders and medical device binders for diagnosisin vitrothey bear the CE marking, in accordance with their purpose and within the limits of use laid down by their manufacturers, in order to place them on the market as systems, assemblies or equipment for medical or surgical procedures.
• Sterilizers of systems, assemblies or equipment for medical or surgical procedures.
• CE marked sterilisers for medical devices intended by their manufacturers to be sterilised before use and for those responsible for their introduction into the market.

The manufacturers, groupers and sterilizers established in Spain need to request a priorPrior operating license of medical device facilities (IPS).For their part, the manufacturers of tailor-made products need an operating license issued by their autonomous community. Manufacturers of custom-made medical devices not established in Spain will be exempt from this license.