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) http://www.igz.nl/. 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.