CathWorks has announced that the CathWorks FFRangio system has been approved under the European Union (EU) Medical Device Regulation, commonly referred to as EU MDR, and fulfils the requirements for CE marking.
EU MDR, the new medical device regulation applicable in Europe, replaces the previous Medical Device Directive. With the introduction of EU MDR, the EU is placing even greater emphasis on safety measures, risk management, post-market surveillance and data collection of medical devices for companies who wish to obtain European market access.
“The requirements of EU MDR are much more rigorous, sometimes compelling medical device manufacturers to rethink their commercialisation strategy in Europe. We are very pleased to have successfully met the rigorous EU MDR requirements and believe this significant milestone underscores CathWorks’ steadfast commitment to quality and patient safety. This approval is perfectly timed for the full European launch of our co-promotion partnership with Medtronic that will be in full display this week at EuroPCR,” said Ramin Mousavi, president and chief executive officer of CathWorks.
