Regulatory Focus™ > News Articles > European Legislators Propose Premarket Approval System for Some Medical Devices

European Legislators Propose Premarket Approval System for Some Medical Devices

Posted 15 June 2012 | By Alexander Gaffney, RAC 

Legislators of the European Parliament (EP) have proposed more stringent safety measures for implantable medical devices, including implant registries, tougher safety inspections, better product traceability and-perhaps most importantly-a premarket authorization system.

The proposed changes come after the discovery of widespread quality issues with now-defunct French implant manufacturer Poly Implant Prothese's breast implant products. The products are purported to have been manufactured using industrial-grade, rather than medical-grade, silicone and concerns have risen regarding their rate of rupture relative to similar products. The European Commission estimates more than 400,000 women have received the implants in Europe alone.

Members of the EP adopted a resolution on 14 June saying the failure of European regulators to discover the device's flaws showcases "malfunctioning at European and national levels, notably a lack of cooperation [and] a lack of traceability of raw materials. Further legislation revising existing regulations in these areas is to be introduced later in 2012, legislators said in a statement.

Perhaps the biggest change proposed by legislators would be the introduction of a European-wide premarket application and authorization system for medical devices, which are currently exempt from the same premarket review process required of pharmaceutical and biologic products. While the system would not apply to all products, it would apply to "dangerous medical devices" and would be either identical to or similar to "the requirements for medical products," said legislators.

Legislators also called for an "urgent" revision to the Medical Devices Directive aimed at "introducing a capacity to detect and minimise the risk of fraud, focusing in particular on provisions regarding market surveillance, vigilance, and the functioning and tasks of notified bodies, so as to avoid a repetition of the PIP case."

Read more:

EP - Breast implants: Parliament proposes stricter safety checks

Text of the proposal (Page 227)

Regulatory Focus newsletters

All the biggest regulatory news and happenings.