Statement on Daily Telegraph faulty medical implants investigation

Press release - 23rd October 2012

Statement on Daily Telegraph faulty medical implants investigation article 23 October 2012:

BSI takes our role as an EU Notified Body extremely seriously and patient safety is paramount to us. To ensure our independent conformity assessments are robust, BSI has continually invested in recruiting specialists with considerable experience and expertise across an array of medical device industry sectors.  We have specialist teams in microbiology, vascular, active implantable, electro medical, wound care, ophthalmic, orthopaedics and In vitro diagnostics to ensure our reviews are carried out by highly competent experienced individuals with directly relevant expertise. 

BSI is confident in our existing approach as a European Union Notified Body (EU NB), however, we are always looking for continuous improvement and work with our competent authority the MHRA to strengthen and develop the EU system in line with new technological innovation.  Our singular aim is to ensure patients in the twenty eight member states are protected by the correct application of the relevant EU directive.

BSI took a leading role with four other EU NB’s, in the development of an EU NB code of conduct.  Team-NB (The Notified Body Association) subsequently adopted this new code of conduct for all members.  The code of conduct ensures members observe mandatory requirements that will effectively improve implementation of the conformity assessment and CE marking processes.  It also focuses, among other things, on qualification and assignment of Notified Body assessors, and minimum times for assessments.  Team-NB now comprises 37 EU Notified Bodies and demonstrates their commitment to strengthening the operating principles of its members.

About BSI

BSI (British Standards Institution) is a global organization that equips businesses with the necessary solutions to turn standards of best practice into habits of excellence. Formed in 1901, BSI was the world’s first National Standards Body and a founding member of the International Organization for Standardization (ISO).

Over a century later it continues to facilitate business improvement across the globe by helping its clients drive performance, reduce risk and grow sustainably through the adoption of international management systems standards, many of which BSI originated. Famed for its marks of excellence including the instantly recognizable Kitemark®, BSI’s influence spans multiple sectors including aerospace, construction, energy, engineering, finance, healthcare, IT and retail. With over 70,000 clients in 150 countries, BSI is an organization whose standards inspire excellence across the globe.