UKCA for medical devices and IVDs
Download our UKCA webinar faqs to know more about taking devices to market in Great Britain post Brexit.
Accessing the European and UK markets bring challenges that can lead to delays in your product launch. Such delays can be costly for the manufacturer, and for patients who require care. However, there are stringent requirements in place to ensure patient and user safety, as well as the performance of the device.
BSI The Netherlands B.V (2797) is a leading European Notified Body; we assess medical devices to ensure that they conform to the requirements of the European Directives and Regulations. BSI UK Assurance Ltd (0086) is a UK Approved Body able to provide conformity assessments under the new UKCA scheme for the Great Britain market.
Keep up-to-date with the latest news and changes by watching our on-demand webinars.
Watch our on demand webinar to hear Dr Jayanth Katta, Head of UK Approved Body, Regulatory Services, talk about BSI's plans as a UK Approved Body and confirm the next steps for Manufacturers to ensure continued access to United Kingdom market from January 2021.
Watch our on demand webinar to hear BSI’s Dr Jayanth Katta, Senior Regulatory Lead, and Gary Slack, Senior Vice President, talk about the Notified Body perspective on the announcement regarding the new UK Conformity Assessed (UKCA) mark.
BSI issues its first UKCA certificate under the UK MDR 2002 legislation for medical devices via its newly designated UK Approved Body (0086).
Tell us about your UKCA Plans by completing our short questionnaire to support resource planning as a possible UKCA Approved Body.
BSI would like to share with you a critical announcement regarding the new UK Conformity Assessed (UKCA) mark for medical devices.
What does this mean for medical device manufacturers?