The proposal for amending the European Directive 93/42/EEC known as the Medical Devices Directive was initiated nearly a year ago on 26 September 2012. The proposals for change were driven by several major medical device issues that have occured recently such as the PIP breast implants which used agricultural silicone rather than a medical grade one.
Pelle Neroth, writing in the IET News of 7 August identifies two camps in the debate. One believes that tightening the national regulatory regimes and bringing them to follow the same high standards across Europe will suffice. The other believes a fundamental overhaul of the approval process is required, possibly closer to that in the US where medical devices are subject to a similar approval process to medicines.
At a meeting organised by the trade association COCIR in April this year, Erik Hansson of the EC described when this Directive impacts on Telehealth. Here in the UK the issue is expected to come to a head next month when Parliament reconvenes after the summer break.