From simple contact lenses and sticking plasters to
sophisticated pacemakers and hip replacements, 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 and in vitro medical devices are
safe and perform well.
The new rules will bring a number of improvement for
medical and in vitro diagnostic devices; such
as enhance vigilance and market surveillance, improve device traceability as
well as make sure that all medical and in vitro diagnostic devices are designed
to reflect the latest scientific and technological state-of-the art. This 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.
The official timings for transition start 20 days
after the new laws are published in the Official Journal. This is expected in
early May, which means an official transition starting date around the 1st of
June. The Regulations will be fully applicable in three years for medical
devices and in five years for in vitro diagnostics medical devices.