For medical devices, CE Marking indicates that products have been produced to conform to the standard required for devices sold in the EU. The CE mark is a legal requirement in order to place a medical device on the market in the EU. It is validated by a certificate issued by a notified body.
Up until 2019, Vitalograph’s CE certification was issued by a UK notified body. Due to Brexit, there is a possibility that CE certificates issued by UK notified bodies may not be valid for placing products on the EU market. To prevent complications, Vitalograph opted to change its notified body from BSI UK to BSI Netherlands.
Our notified body number has now changed from BSI UK (0086) to BSI-NL (2797). We are in the process of updating our products, packaging and documentation to reflect the change in CE Mark details. During the transition, you may see either CE Mark on our products and documentation. Regardless, our products continue to meet the same high standards and are approved for the EU market.
The relevant certification confirming the CE mark change is shown below. If you have any queries or concerns, please contact us.