We witnessed several changes in the medical device industry in the year 2018. The impact of some changes was hard-hitting while some were received with a warm welcome by industry professionals. It sure is a difficult and confusing time for the medical device industry to...
Medical Device manufacturers selling their devices in the European Union are currently in a three-year transition period to comply with the new EU MDR 2017/745. There are quite a few changes proposed in the new regulation that medical device companies need to establish compliance with;...
Medical devices in the UK are regulated by the directives put forth by the EU, including: Active Implantable Medical Devices Directive (AIMDD) Medical Devices Directive (MDD) In Vitro Diagnostic Medical Device Directive (IVDD) High risk medical devices are certified by an independent conformity assessment conducted by...