The European Parliament has approved the European Commission’s proposal for two new Regulations on medical devices that aim to ensure better protection of public health and patient safety.
There are over 500,000 types of medical devices and in-vitro diagnostic medical devices on the EU market, such as pacemakers, breast implants, hip replacements, HIV blood tests, pregnancy tests and blood sugar monitoring systems for diabetics.
The existing regulatory framework dates back to the 1990s and consists of three Directives. However, problems with differences in the interpretation and application of the rules, technological progress as well as incidents involving malfunctions of medical devices–i.e. the PIP breast implant scandal- highlighted the need for revision of current legislation.
The new Regulations on medical and in-vitro diagnostic medical devices proposed by the Commission in 2012 will help to ensure that all medical devices are safe and perform well.
To achieve this, the new rules will improve market surveillance and traceability as well as make sure that all medical and in vitro diagnostic devices are designed to reflect the latest scientific and technological advances. The rules will also provide more transparency and legal certainty for producers, manufacturers and importers and help to strengthen international competitiveness and innovation in this strategic sector.
"I'm extremely happy that our push for stricter controls of medical devices on the EU market will now become a reality,” said Elzbieta Bienkowska, Commissioner for Internal Market, Industry, Entrepreneurship and SMEs. “Whether for medical devices, cars or other products, we must ensure stronger supervision in the interest of our citizens. We should not wait for another scandal instead we should start a discussion how to strengthen European oversight over Member States' market surveillance activities."
To allow manufacturers and authorities to adapt, the new rules will only apply after a transitional period, which will be three years after publication for the Regulation on medical devices and five years for the Regulation on vitro diagnostic medical devices.
MEPs gave their backing to the proposals earlier this month.
"The metal-on-metal hip scandal highlighted weaknesses in the current system. So we’ve introduced much stricter requirements for the bodies that authorise medical devices, and will insist that particularly high risk devices, such as implants, joint replacements or insulin pumps, be subject to additional expert assessments before they can be authorised,” explained medical devices rapporteur Glenis Willmott (S&D, UK).
“We've also agreed a much stronger system of post-market surveillance so that any unexpected problems are identified and dealt with as soon as possible,” she added. “With the PIP breast implants scandal, many women simply didn’t know if they had received defective implants or not. So we’ve also introduced a Unique Device Identification system to help trace patients, who will also be given an implant card, which they can use to access information via a publicly accessible database.”
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