(By Balachander) The European Commission has proposed new rules on medical devices and in vitro diagnostic medical devices after recent scandals about faulty silicone breast implants and problems with some metal-on-metal hip replacements highlighted the need for greater transparency.
The EU is adopting proposals on medical devices in a move to further strengthen patient safety after the existing regulatory framework has come under harsh criticism, in particular after the French health authorities found that a French manufacturer (Poly Implant Prothèse, PIP) had for several years apparently used industrial silicone instead of medical-grade silicone to make breast implants contrary to the approval issued by the notified body, causing harm to thousands of women around the world.
The commission proposes important changes regarding various aspects relevant for the life-cycle of medical devices, such as the scope of the legislation, the pre-market assessment of devices, their control once on the market, the transparency of data concerning marketed devices and the management of the regulatory system by the authorities.
The EU plans will affect a huge range of medical devices including: home-use items like sticking plasters, pregnancy tests and contact lenses to x-ray machines, pacemakers, breast implants, hip replacements and HIV blood tests.
Health and Consumer Policy Commissioner John Dalli said the proposals adopted significantly tighten the controls so as to ensure that only safe devices are placed on the European Union's market at the same time, they foster innovation and contribute to maintaining the competitiveness of the medical device sector, which has an estimated market value of around 95 billion euros.
The new proposals include wider and clearer scope of EU legislation, extended to include, for example, implants for aesthetic purposes, and clarified for instance, as regards medical software. This will ensure that the safety and performance of these products are correctly assessed before they are placed on the European market, the commission said.
The European industry association Eucomed welcomes most of the recommended measures in the EU proposal but voices strong concern with regards to the 'scrutiny procedure', saying it will ultimately harm patients and will negatively impact European governments and industry.
Eucomed said the proposed scrutiny procedure will "fundamentally change the current system and will not lead to the desired outcome of increased safety for patients."
The measure would address some political calls to move the system towards a centralised pre-market authorisation system as found in the United States but will ultimately result in harming European patients and negatively impact mostly European small and medium sized enterprises (SME), said the industry body.
BEUC, The European Consumer Organisation, said it welcomes the intention to improve post-marketing monitoring, but regrets that the plans fall short of increasing quality and safety standards before these products reach consumers.
"Consumers must be given more and better information on medical devices while having the backup of redress if things go wrong such as in the case of the PIP breast implants scandal," Monique Goyens, Director General of BEUC, commented.
The Commission expects that the proposals will be adopted in 2014 and would then gradually come into effect from 2015 to 2019.