On May 25, 2016, the EU agreed on new rules on medical devices and
in vitro diagnostic medical devices—almost four years since
the European Commission first published its proposal. The European Parliament finally, on
June 14, 2016, published the agreed texts of the two
regulations set to replace the existing three directives that
currently regulate medical devices in Europe. The new rules seek to
reform the regulation of medical devices in the EU and ensure the
safety of medical devices by two means: strengthening the rules on
placing devices on the market and tightening surveillance once they
are available.
The new rules introduce a number of key changes. First, the scope
of the rules is expanded to include devices with purposes related
to prediction and prognosis of diseases and groups of products
without an intended medical purpose, such as contact lenses for
cosmetic purposes, fillers, equipment for liposuction, and products
used for tattooing. Notified Bodies (the independent bodies that
are responsible for assessing medical devices before they can be
placed on the market) will face stricter rules and will have the
right and duty to carry out unannounced factory inspections.
Certain high-risk devices, such as implants, may undergo additional
checks by experts before they are placed on the market. There is
also a focus on traceability, and manufacturers will be required to
place a unique device identification on their medical
devices.
Sign-off by Parliament and Council is expected by autumn, with the
texts being adopted by the end of autumn and official publication
at the beginning 2017. The new rules will apply three years after
official publication with regard to medical devices and five years
after official publication with regard to in vitro diagnostic
medical devices.
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