EU agrees to tougher rules on authorisation and surveillance of medical devices and in vitro medical devices
Representatives of the European Parliament and the EU Council of Ministers have agreed on two draft regulations that will strengthen the rules on placing devices in the market and tighten surveillance once the devices that are available.
The agreement, which the parliament and council still have to clear formally, will further tighten the rules for the independent bodies that are responsible for assessing medical devices before they can be placed on the market.
Certain high-risk devices, such as implants, may undergo an additional check by experts before they are placed on the market.
The new rules will also strengthen the surveillance of these notified bodies by national authorities.
Additionally, the guidance will establish explicit provisions on manufacturers' responsibilities for the follow-up of the quality, performance and safety of devices placed on the market.
Manufacturers and other economic operators will have clear responsibilities, for instance on liability, but also on registering complaints on devices. The draft regulations will also improve the availability of clinical data on devices, according to the European Council.
A central database will be set up to create a system for all relevant information the European Council has said.
It will cover economic operators, notified bodies, market surveillance, vigilance, clinical investigations and certificates. In addition, it will provide patients, healthcare professionals and the public with comprehensive information on products available in the EU.
This will enable them to make better informed decisions and according to the European Council, patients who are implanted with a device will be given key information on the product, including any precautions which might need to be taken.
Devices will have a unique identification number to provide for traceability throughout the supply chain to the end-user or patient.
Edith Schippers, minister of health of the Netherlands and president of the EU Council, said: "This agreement matters to all citizens: sooner or later all of us enter into contact with medical devices to diagnose, prevent, treat or alleviate diseases.
“The deal reached will improve patients' health and it will help to enhance the quality of life of disabled persons. It will also ensure a level playing field for the 25,000 medical devices manufacturers in the EU, many of which are SMEs and which employ more than half a million persons."
The Council's Permanent Representatives Committee will be invited to endorse the agreement probably mid-June 2016.