ISO 13485 after brexit
Read the news article to learn more about the validity of accredited management system certificates issued by UK based conformity assessment bodies following the UK's departure from the EU.
Accessing the European market brings 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 (2797) is a leading Notified Body; we review medical devices to ensure that they conform to the requirements of the European Directives and Regulations. BSI UK (0086) is a UK Approved Body able to provide conformity assessments under the new UKCA scheme.
CE marking is the medical device manufacturer’s claim that a product meets the General Safety and Performance Requirements (GSPR) of all relevant European Medical Device Regulations and is a legal requirement to place a device on the market in the European Union.
To understand which requirements you need to meet, you must classify the device and identify the appropriate conformity assessment route for your product. This dictates the required activities to demonstrate conformity.
We will review the route you chose to confirm its suitability, and work with you to execute the most efficient review process for the route selected. Our trusted review processes allow you to build reliability and confidence into your CE marking project planning.