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MDR certification secured for Impede embolization plug devices
Shape Memory Medical announced that its Impede embolization plug product family has received certification as a Class III device under the European Union (EU) Medical Device Regulation (MDR) 2017 The Impede devices, previously CE-marked under the Medical Device Directive 93/42/EEC…
Medical Device Regulation goes into effect across EU
The European Union (EU) Medical Device Regulation (MDR) takes effect from today (May 26). The Regulation revises quality and safety standards and the range of regulated devices and was first initiated in May 2017, with an initial three-year transition period…