New euro approval system ‘huge burden’ on smaller health care groups

Earlier this week, European Union lawmakers backed a strict new approval system for high-tech medical devices, raising industry fears of added delays in getting new products to mar- ket.

Members of the European Parliament’s environment committee voted in favour of a new pre-market authorisation system of randomised clinical trials for implantable devices, covering everything from hip replacements to artificial heart valves.

Moves to tighten the rules followed a 2011 scandal involving a now defunct company which made sub-standard breast implants that were used by hundreds of thousands of women around the world.

In response, the EU’s executive – the European Commission – has proposed increased monitoring of device manufacturers and tougher government oversight of the 80 or so mostly private bodies that decide on product safe- ty.

The committee vote went far beyond the commission’s original proposals, calling for the establishment of a new pre-marketing authorisation system for high-risk devices under the control of the European Medicines Agency (EMA).

Jason Brannan, of Medilink which helps to develop health companies in Yorkshire, said yesterday: “Rather than speed up the time it takes for patients to benefit from new life-saving medical technologies, the move to create a new European wide pre marketing approval process for medical devices, would have the opposite effect, and add a significant and unacceptable burden on the UK’s small and medium-sized healthcare companies.”