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Reactie: BSI

Dit is de reactie van Notified Body BSI op de uitzending van Radar van 1 december 2014, over de CE-goedkeuring van implantaten.

Notified Body BSI liet aan Radar weten patiëntveiligheid voorop te stellen en altijd op zoek te zijn naar verbetering. BSI ondersteunt de nieuwe wijzigingen in de wetgeving in het Europees Parlement. Lees hier de volledige reactie van BSI (in het Engels):

'We were concerned to learn of the hidden camera footage filmed by Avrotros Radar broadcast on 1 December at one of our Medical Devices CE Marking training courses in the UK. The footage used, which is less than three minutes long, is heavily edited, misleading and very unrepresentative of the course content covered over the three days.  In no way does our training undermine the regulatory requirements and processes of the EU Directives that medical device manufacturers have to meet in order to apply for the CE Mark.

The course outlines in depth the regulations and is designed to increase understanding of the correct essential requirements for different devices and technologies, so that those attending such courses come away with an understanding of the regulatory requirements and the tools to apply it to their own situations in a knowledgeable manner.

The course certainly does not address the "easiest way to get the CE mark". It ensures manufacturers understand the significant importance of meeting the requirements and how they relate to ensuring patient safety.

BSI takes our role as an EU Notified Body extremely seriously and patient safety is paramount to us.  We are 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 the interest of patient safety.  As a result of transfers to BSI from other European Notified Bodies, we are aware of the variable application of the requirements by a few Notified Bodies and have lobbied the MHRA pro-actively for this to be addressed. Allied to this, BSI strongly supports the proposed changes in legislations currently going through the European Parliament.'

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