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; a recognized Auditing Organization under the Medical Device Single Audit Program involved in many other regulatory schemes globally.
Earlier this year BSI formally applied for designation as a Medical device Notified Body in the Netherlands under the EU Directives; (90/385/EEC) Active implantable medical devices, (93/42/EEC Medical devices) and (98/79/EC) IVD directive within the oversight of the Dutch Healthcare Inspectorate (IGZ) http://www.igz.nl/.
The intent is to further develop and secure BSI’s EU Notified Body activity in mainland Europe and continue building to establish a significant presence in the Netherlands over the next two years. This presence is focussed upon the existing BSI Netherlands headquarters in Amsterdam. Following the application made in February, next steps are a Joint Assessment of BSI by EU Competent Authorities and European Commission representatives later this year, with completion of the designation process targeted by the end of 2017.
Once the forthcoming MDR and IVDR legislation is adopted, BSI is already working on applying for designation in the Netherlands and the UK at the earliest date permitted, likely November 2017.
BSI has also applied to the Dutch Accreditation Council (RvA) for accreditation to issue ISO 13485 certificates direct from the Netherlands under RvA accreditation to ensure a European Union country accreditation continues to be available for ISO 13485 from BSI.
BSI will retain our significant 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.