The European Commission (EC) has adopted a proposal to postpone by one year the date of application of the new Medical Devices Regulation (MDR), which was due to come into force on 26 May this year. The postponement, a press release reports, is to allow Member States, health institutions and economic operators to prioritise [...]
During a Q&A section of a European Commission (EC) college meeting on 25 March, EC spokesperson Stefan de Keersmaecker stated that the commission were looking to delay the “entry into force” of the new European medical device regulations (MDR) because of the global coronavirus pandemic. de Keersmaecker, who spoke via video, said: “The EC [...]
Richard Houlihan For those involved in the MedTech industry, unless you have been living under a rock, you will know about the new European medical device regulation (MDR). Furthermore, you will know that Eudamed is at the core of the MDR. However, to recap, MDR-Eudamed is where specific medical device economic operators [...]
Jeffrey B Jump In a move to improve the safety of medical devices, in May 2017, the European Union (EU) announced a series of new Medical Device Regulations (MDR) and these are due to come into full force in May next year (2020). These new regulations will not only affect new products [...]
Biotronik has become the world’s first manufacturer to receive European Medical Device Regulation (MDR) certification for a Class III (highest risk) medical device. Following a successful conformity assessment, the company also obtained MDR certification for its quality management system. Class III medical devices represent the highest risk class of medical devices according to the [...]