SAMD (Software as a Medical Device) is a complex area and over the course of the 26 years, since the Medical Devices Directive 93/42 EC was first enforced for devices to be sold in the EU market, software development has advanced leaps and bounds. From Artificial intelligence to Wearable technology, Mobile applications and sophisticated monitoring devices and much more, the Standards and guidelines that have supported the MDD namely BS EN 62304: 2006, which has an addendum of 2015, still requires the updates of the new EU MDR 2017/745, specifically rule 11 which classes Software as a stand alone device with monitoring and diagnosis with further details. These significant changes have led to much confusion amongst medical device companies, but we are committed to answering your questions about the EU MDR and providing you with ancillary tools to assist in your EU MDR compliance efforts.

Our partners at Pharmi Med have produced a guidance document and audit tool against the new EU MDR 2017/745, utilising the State of the Art (SOTA) standard - BS EN 62304, and also referencing the IMDRF guidelines to ensure compliance with the needs and requirements of the new regulations. This guidance and tool allows you to assess your current documentation in correlation to the expectations of the notified bodies, regardless of classification of your device.

Stay ahead of the competition and review your requirements now!

_{Note: these resources do not take into consideration cybersecurity requirements or electrical safety. Visit Pharmi Med Template Shop for additional resources and tools.}