Keeping track of traceability – preparing for the EU medical device regulation

Introduction

The term ‘medical device’ is broad and covers a wide rangeof items. It is referred to most commonly as an apparatusor a piece of equipment that is used to treat or diagnose acondition that comes into direct contact with the patient.Whether it is a simple pair of contact lenses or a moresophisticated device such as a pacemaker, the frequency withwhich we encounter medical devices in our day-to-day lives issurprisingly high and the key role they play in our well-beingremains undeniable.

It is because of this role that regulations surrounding medicaldevices tend to be placed under more stringent scrutiny.Under the FDA (Food & Drug Administration) rule in theUSA, manufacturers have been required to implementUDI (Unique Device Identification) on all medical productpackaging since September 2014. Following this and in lightof the recently adopted EU Medical Device Regulation,European manufacturers of medical devices will face eventougher regulations to ensure their products are safe to useunder new EU laws that are scheduled to come into effectfrom May 26th 2020 onwards