BSI to open a second EU Notified Body based in the Netherlands

Enews - 21 November 2016

BSI is a leading provider in the Medical Device regulatory space – it is the largest EU Notified Body; a global provider of Medical Device audits to ISO 13485; part of the Medical Device Single Audit Program pilot; and other regulatory schemes.

As part of its expansion plans, BSI has now commenced application for designation under the EU Directives 90/385/EEC Active implantable medical devices and 93/42/EEC Medical devices within the oversight of the Dutch Healthcare Inspectorate (IGZ) This initiative is designed to expand and further develop its EU Notified Body activity in mainland Europe and over the next two years, we will build a significant presence in the Netherlands.

Once the forthcoming MDR and IVDR legislation is adopted, BSI aims  to get designation in both the Netherlands and the UK.

BSI remains a UK-based Notified Body and fully expects that it will be able to continue providing this service as NB 0086 under the UK regime agreed with the EU.