Brett Rowland, partner and health and life insurances expert at Eversheds, has commented on proposed new laws governing medical devices being debated in the EU parliament.
He said: ‘Under these proposed new laws, the medical device approval process will be significantly more strenuous, will embrace a larger number of products and is likely to take longer. Clinical data will be made available to the public in regard to high-risk devices and manufacturers will need to undertake more analysis both before and after the marketing process begins. Many companies may have to change their procedures to comply and will ultimately have to bear any associated additional costs.
According to Rowland, the changes come in the wake of the high-profile PIP breast implant scandal, in which the use of unauthorised industrial-grade silicone remained undetected by the regulatory authorities for years before being exposed following a tip-off.
He added: ‘However, many within the industry have questioned whether the PIP scandal would have been averted under the new rules, and there is concern that the onerous burden of implementing the new requirements will further raise the barriers to entry in a sector where costs are already very high.’