Germany extends global testing for medical devices
Press release - 16 November 2011
The British Standards Institution (BSI) announces today that EUROCAT, the German medical devices Notified Body and Test House owned by the BSI Group, will re-brand to BSI.
The re-branding of EUROCAT reflects BSI’s commitment to recognising Germany as a critical market for medical device certification, and its vision to ensure Germany continues to develop as an integral part of its global testing and certification platform.
The BSI rebranding is also expected to attract new business by ensuring BSI Healthcare Germany offers a truly global market access capability attractive to the larger international players within the German, Austrian and Swiss medical devices market.
Since acquisition and investment from BSI in 2009, EUROCAT has gained new accreditations including International Laboratory Accreditation Cooperation (ILAC) and the extension for high-risk in-vitro diagnostics helping improve BSI’s credibility within the medical devices market.
“EUROCAT already has an enviable recognition at a national level,” said founder Werner Kexel. “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. BSI remains committed to retaining German Notified Body status and therefore the well-known EUROCAT number CE 0535 will remain unchanged.
“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,” said Gary Slack, Director 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, as well as the importance of the medical devices industry within the certification market,” he concluded.