The European Parliament’s ENVI Committee vote on the proposals for Regulations on Medical Devices and InVitro Medical Devices has been postponed for the second time. There are rising concerns by health stakeholders regarding the speed of the process, as ongoing delays undermine public trust in the EU’s ability to create legislation that will adequately protect patients.
On Wednesday 18 September, the ENVI committee postponed the vote on the Medical Devices Regulations for the second time. Although it has only been pushed back by one week, this means it is occurring two and a half months after the original date of 10 July.
While arguably, [the vote has been delayed while MEPs and officials attempted to reduce the number of amendments and find workable compromises, delays at this stage might foreshadow further problems down the line. This would be bad news for patients, especially at a time when cross-border care is growing and patients ask for reassurance that medical devices placed on the EU market are secure.
In a recent press statement, the International Association of mutual benefit societies (AIM) reminded that it is urgent to make a breakthrough on this file in the interest of patients who must be able to rely on safe medical devices.
EPHA recently published its updated Position on Medical Devices. Overall, it asks for more transparency over the entire process while avoiding unnecessary delays. EPHA supports the objectives of the European Commission and agrees that patient safety must stand at the heart of the new Regulations.
A number of scandals exposed the weakness of the current legislation which dates from the 1990s. The medical devices industry is one of the most dynamic in healthcare, providing innovative solutions for diagnosis, prevention and treatment every day. The new legislation should take into account the rapid evolution of the technology (also regarding the convergence between medical devices and eHealth) and ensure that patients can benefit from safe devices in a timely fashion.
The main controversy has been over the type of marketing authorisation procedure (i.e., the tightening of existing procedures proposed by the Commission versus pre-market authorisation - PMA - for certain high-risk devices, as proposed by MEP Roth-Behrendt (Germany, S&D)).
EPHA would like to see no more delays over the process in order to restore trust amongst the patients and guarantee patient safety.
EPHA related articles