The European Parliament has adopted new regulations for in vitro diagnostic medical devices and medical devices to enhance public health and patient safety.
Proposed by the European Commission in 2012, the new regulations are meant to ensure the safety and performance of all medical devices.
The three existing directives on medical devices will now be replaced by the two new regulations, which are set to provide improved market surveillance, traceability, transparency and legal certainty for producers, manufacturers and importers.
High-risk devices such as implants will be under tighter control and will require consultation of a pool of experts at European Union (EU) level.
Controls on clinical trials and bodies with authority to approve the marketing of devices will also be tightened and certain previously unregulated aesthetic products, such as coloured contact lenses, will also be addressed.
In addition, a new system for risk classification in accordance with international guidelines will be applied to in vitro diagnostic medical devices.
The new regulations include patient benefits, such as an EU database on medical devices (EUDAMED) with a live picture of all the EU market products, a new device identification system, an implant card with details on implanted medical devices and financial coverage.
They will also cover security and regulatory certainty of drug-device combination products, nanoscience, tissue engineering, personalised medicine and genetic tests.
The new rules will be applicable after three years of official publication for medical devices and after five years for in vitro diagnostic medical devices.