The British Standards Institution (BSI) is strengthening its presence in the German medical devices market by rebranding EUROCAT, the German medical devices Notified Body and Test House owned by the BSI Group, as BSI Healthcare Germany.
The rebranding of EUROCAT is expected to attract new business by offering a global market access capability to companies in the German, Austrian and Swiss medical devices markets.
BSI’s increasing investment in Germany shows the country’s growing importance within the European medtech market.
The new organisation will retain German Notified Body status and continue to use the EUROCAT approval number CE 0535.
Since its acquisition by BSI in 2009, EUROCAT has gained the capacity to approve high-risk in vitro diagnostics, raising its profile in the medtech market.
EUROCAT founder Werner Kexel said: “Without doubt the German medical devices market will benefit from the values associated with the BSI brand. BSI holds a significant market position across the globe based on world expertise, capability and quality of service.
“This, coupled with the ongoing investment which has been evident since the acquisition, will allow Germany to offer a testing services business with a truly global footprint, which we hope will attract new business from larger industry players.”
“In a difficult economic climate medical device manufacturers are under increasing pressure to become more efficient and increase the speed of their products to market,” commented Gary Slack, Director of BSI Healthcare.
“In response BSI is striving to help manufacturers gain market confidence by enhancing its capability and presence in the German market and by improving links with government competent authorities in Germany.
“Bringing EUROCAT under the BSI brand is evidence of BSI’s continued commitment to recognising Germany as a critical market for medical device certification,” he concluded.