This review summarizes the European rules to control the market when introducing new products. In particular, it shows all the steps to achieve the European Conformity (CE Mark), a certification that all new medical products must achieve before being used in Europe. Extracorporeal membrane oxygenation (ECMO) devices are exposed to the same procedures. Hereby, we present some regulatory issues regarding pumps and oxygenators, providing technical details as released by the manufacturers on their websites and information charts.
- centrifugal pumps
ASJC Scopus subject areas
- Radiology Nuclear Medicine and imaging
- Safety Research
- Cardiology and Cardiovascular Medicine
- Advanced and Specialised Nursing