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.