Most members will be aware that when the UK left the EU we adopted a different regulatory environment for medical devices to the Medical Devices Regulation (MDR) that the EU implemented on May 26th. The UK Conformity Assessment (UKCA) covers a wide range of goods and services so for this webinar we will be focusing only on its provisions for medical equipment, where it is very similar to the old EU Medical Devices Directive (MDD). There are though some important differences, and a need to register devices to a timetable driven by existing classification levels.
A key element of both pieces of EU legislation is the concept of Notified Bodies – organisations that do the heavy lifting to ensure regulatory compliance, the largest of which in the UK, and one of the largest in the EU, is the BSI. It was therefore particularly welcome that Vishal Thakker, Regulatory Lead for Regulatory Services (Medical Devices) at BSI and Dr Fiona Dunn, Senior Technical Specialist & Scheme Manager – Active Devices, kindly agreed to speak to us on Wednesday June 16th.
Their presentation, is superbly focused on helping digital health SMEs to understand regulation and to know what to do to achieve regulatory approval for their software and hardware.
A copy of the recording is here.
The BSI has also recently updated its website on UKCA matters – there’s a trove of useful stuff here.