BSIF contributes to solving the Medical Devices 'problem'
October 1st 2009 The collective influence of the BSIF, in conjunction with European NGOs and Trade Bodies, the UK Department for Business Innovation and Skills [BIS] and the European Safety Federation [ESF], has persuaded the EU Commission to resolve the current difficulties with Medical Devices [MDs] which offer protection to the wearer. The MD Directive states that a medical device cannot be anything else, such as PPE. It was then amended to incorporate the concept that a medical device could be "protective" and take account of the PPE Directive but still prevented dual packaging and permitted the placing on the market of "protective" medical devices without any requirements for independent testing and quality certification.
This opened the door for substandard product to be sold into the industrial sector. The EU Commission has now issued “an interpretive document" which states that where a medical device is also claiming to offer protective properties, it must be subject to the same compliance regime as is applicable to PPE. More articles from BSIF Enterprise: | 
