A European medical device representative is an individual or entity appointed by a manufacturer based outside of the European Union to act as their authorized representative within the EU. The representative is responsible for ensuring that the manufacturer's medical devices comply with the EU's regulatory requirements, including registration, labeling, and post-market surveillance.
A Medical Device Free Sale Certificate is a document issued by the regulatory authority of a country to a manufacturer of medical devices, certifying that the medical devices are freely sold in that country's market and are approved for commercialization. The certificate serves as evidence that the medical devices meet the regulatory requirements of the country of origin and can be legally marketed and sold in other countries. It is often required by regulatory authorities in other countries as part of the product registration process.
Medical device registration in the EU refers to the process by which medical devices are authorized to be placed on the market and used within the European Union. The process involves complying with the regulatory requirements set forth in the EU Medical Devices Regulation (MDR) or In Vitro Diagnostic Medical Devices Regulation (IVDR), depending on the classification of the device.
EPREL stands for the European Product Database for Energy Labelling. It is an online database that provides information on the energy efficiency of products sold in the European Union. Manufacturers are required to register their products on EPREL before they can be sold in the EU. This allows consumers to make informed decisions about the energy efficiency of the products they purchase.