Imprecise interpretation of clinical data requirements continues to cause regulatory problems in EU

Dec. 10, 2008 - PRLog -- London – The international medical devices regulatory consultancy Quality First International has again expressed concern about the lack of uniform practices for the assessment and scrutiny of clinical data in the European Union.

“There is an imprecise and even cavalier interpretation of the clinical data regulations by protagonists in CE Marking, plus an apparent disregard for Council Directive 85/374/EEC (as amended) and supporting Member State consumer protection legislation,” explains Haroon Atchia, CEO and Technical Director at Quality First International. “Although many Notified Bodies are known to be making improvements, tackling disregard for the obligations contained in these pieces of legislation still needs more attention; in fact it is often implied that the requirements for demonstration of safety and performance (effectiveness) are negligible. Copious examples exist of manufacturers who have little or no clinical data whatsoever yet achieve CE Marking. The position, however, is slowly changing with enforcement by Competent Authorities becoming more frequent, as well as pressure from the Courts”, says Mr Atchia.

“Amending Directive 2007/47/EC has helped to clarify the requirements for clinical data: a manufacturer must demonstrate that a medical device complies with the Essential Requirements and other provisions of the Directive, so, incontrovertible evidence of compliance for all classes of medical device must be compiled. Therefore, as demonstration of safety and performance is clearly necessary to fulfil the legal requirements, it is the only sensible approach for manufacturers to adopt”.

Mr Atchia concludes, “Europe still has a long way to go before it reaches the level of safety that is mandated by the legislation, and its path is being hampered by the failings of the current third-party certification system. The European Commission must be willing to implement proper scrutiny of clinical data and statutory obligations either for central scrutiny or to empower Notified Bodies to examine this aspect of Conformity Assessment if the situation could reach the level obliged”.

About QFI:
QFI provides a wide range of regulatory, scientific, technical and QMS consulting services, and is able to assist in queries about changes to the Directives, national transpositions (including registrations etc), as well as interpretation of the regulations. QFI operates in the UK, Germany, Israel and USA plus consults widely around the World.

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London-based medical devices consulting company specialising in solving its clients’ regulatory, technical and compliance challenges to enable medical devices to enter the global marketplace.