In late October, MEPs (Members of the European Parliament) backed proposals for tighter rules to safeguard patients using medical devices. The rules would not only affect pre-market but post-marketing devices too.
The call for tighter control was prompted by the well-publicised scandal, when the French company, Prothèse, used non-medical grade silicon in hundreds of thousands of breast implants.
According to ENVI (The Committee on the Environment, Public Health and Food Safety) and the European Parliament, notified bodies (responsible for market approvals) will in future monitor medical devices even after they have been approved. Special controls will also be introduced governing the approval of high-risk devices such as pacemakers.
The EU device industry association, EUCOMED, fears that the changes will have a serious effect on smaller device manufacturers. It claims that the changes may cost as much as much as £15 billion and may delay market launches by up to 5 years.
Medical devices are already subject to well defined vigilance procedures, albeit often less strictly defined than those applying to pharmaceuticals. However, there are already rules in place for reporting adverse events and the rules covering causality, risk assessment etc still apply.
Whitehall training’s newly-published Device Safety and Vigilance online course covers all aspects of the subject from the definition of adverse events to international variations in the classes of devices. It also looks at some of the most commonly used ways of assessing data in the calculation of risk.
Rest assured that we will be following every development in the EU and elsewhere and updating our course with the very latest information.
