Medical devices marketed in the EU will face tougher regulations following the scandal surrounding faulty PIP breast implants.
The European Commission (EC) announced proposals to tighten controls for both medical devices and in vitro diagnostic devices, citing the discovery that certain breast implants were found to be made with low-grade silicone with an increased risk of rupturing as one its main motivations.
“Just a few months ago, everybody was shocked by the scandal involving fraudulent breast implants which affected tens of thousands of women in Europe and around the world,” said the EC’s health and consumer policy commissioner John Dalli.
“As policy makers, we must do our best never to let this happen again. This damaged the confidence of patients, consumers and healthcare professionals in the safety of the devices on which they rely every day.”
The proposed policies address both the assessment of a device’s safety ahead of approval, as well continued surveillance post-launch.
Measures designed to improve patient safety include a “wider and clearer scope of EU legislations”, which will include implants for aesthetic purposes in what seems to be a direct response to the PIP controversy.
In addition, the EC has also suggested stronger supervision of independent assessment bodies by national authorities; more powers and obligations for assessment bodies; and improved traceability of devices to enable a faster response to any problems.
Better coordination between national surveillance authorities is also recommended.
The measures were broadly welcomed by industry trade body Eucomed, although concerns were raised about the ‘scrutiny procedure’ proposed by the EC.
This procedure will change the system to something akin to the US’ centralised pre-market authorisation system.
However, according to Eucomed, this could be harmful as patients in the US can wait on average three to five years longer for access to the same device as those in Europe, while no additional safety is delivered.
“This procedure will fundamentally change the current system and will not lead to the desired outcome of increased safety for patients,” said Eucomed in a statement.