Recent information from the EU Commission indicates that the 15 recent re-designation audits of medical device notified bodies have resulted in 10 de-designations of those notified bodies. So, it is more important than ever for manufacturers to select notified bodies operating at or near the best practice levels. Membership of Team-NB – The European Association of Medical devices Notified Bodies – is one way to achieve and demonstrate best practice standards.
It has been accepted for several years that the EU notified bodies in the field of medical devices have been operating at varying levels of competence, resource and interpretation of the legislation. This realisation led to two important EU Commission documents issued in 2013:
- Commission Implementing Regulation 920/2013 on the designating and the supervision of notified bodies under Council directive 90/385/EEC on active implantable medical devices and Council Directive 93/42/EEC on medical devices
- Commission Recommendation 2013/473/EU on audits and assessments performed by notified bodies in the field of medical devices
Because of these new requirements, a 3-year programme of re-designation or ‘joint audits’ of all notified bodies started in 2013 and will finish in 2016. These are in-depth and lengthy audits of competency, resource at all level of assessment, and implementation of all the strengthened requirements such as internal clinical expertise and unannounced audits. It is the outcome of the first 15 of such audits that provided Erik Hansson of the EU Commission with the information to publically state at a TOPRA Conference on 14 October 2014 that 15 such audits had been undertaken and had resulted in 10 de-designations of notified bodies. Thus incompetent and poorly resourced notified bodies are already being squeezed out of the market.
Team-NB was set up in 2001 with SGS United Kingdom Limited as Notified Body 0120 – Chris Jepson of SGS was a founder member and the first president. In recent years, the association has written and subsequently revised a ‘Code of Conduct for Notified Bodies under Directives 90/385/EEC, 93/42/EEC and 98/79/EC’. This goes further than any EU Commission guidance in specifying minimum requirements for the following areas:
- Qualification and assignment of notified assessment personnel
- Minimum time for notified body assessments
- Unannounced audits
- Sampling of class iia and iib medical device technical files
- Design dossier reviews
- Verification of manufactured products for the IVD directive
- Rules for subcontracting
- Rules for certification decision
The code of conduct not only sets out requirements but as adherence to the code of conduct is a mandatory requirement for Team-NB membership it has instituted an audit process whereby a team of two independent auditors audit each member to ensure compliance. SGS as Notified Body 0120 has recently successfully received such an audit. This process gives manufacturers confidence that membership does assure good practices, competent assessment personnel and sufficient inhouse resources and should be used as one criteria for their choice of notified body.
The last 12 months has certainly seen the beginning of the rationalisation process of notified bodies for medical devices with notified bodies disappearing; limitations of designated scope; de-designations from one or more directives, and resignations from Team-NB due to the code of conduct becoming a mandatory requirement. This process has much further to go with estimates of the final number of notified bodies varying from 20 to 40 instead of the current 60 plus. Team-NB will also continue its process of updating the code of conduct to reflect best practice and EU Commission requirements.
SGS is the world’s leading inspection, verification, testing and certification company. SGS is recognized as the global benchmark for quality and integrity. With more than 80,000 employees, SGS operates a network of over 1,650 offices and laboratories around the world.