Impending Changes to the European Union (EU) Medical Device Regulations
Driven by the need to toughen the regulatory landscape to improve patient safety and to keep up technological progress and innovation, the European Commission proposed updates to the Medical Device Regulations. These updates were adopted on 26 May 2017 in the EU and will come into force from 26 May 2020 for medical devices, and from 2022 for in-vitro diagnostics devices.
The new regulations will impact every element of the supply chain, including all medical device raw material suppliers, component/parts manufacturers, device manufacturers, distributors, retailers, and customers/consumers.
Our latest report Impending Changes to the European Union (EU) Medical Device Regulations highlights that companies need to scrutinise their risk management plans now with respect to the new EU medical device regulations. They also need to consider how the changes will affect the risks they face and the industry specific insurance cover they need to have in place.