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On Sep. 26, 2012, the European Commission (EC) proposed two
Regulations which would replace the existing rules regarding sales
of medical devices and in vitro diagnostic medical devices
in the EU. These new rules will apply to all devices sold in the
EU, whether produced in the EU or produced in a third country and
imported into the EU. Businesses selling such devices in the EU
should be aware of the proposed changes and consider whether they
wish to seek to influence the shape of the rules.
The principal changes which would be introduced by the proposals
relate to the scope of the legislation, the pre-market assessment
of devices, their control once on the market, the transparency of
data concerning marketed devices and the management of the
regulatory system by the authorities.
The EC had been working on these proposals before the PIP breast
implant scandal in the EU. However, the EC has analysed that
incident in order to seek to ensure that the proposals are robust
enough to stop such problems occurring again.
The proposals incorporate guidelines developed at international
level into EU law with a view to converging the regulatory
requirements for medical devices and in vitro diagnostic
medical devices in major economies.
The proposals will be discussed in the European Parliament and
in the European Council. The EC's target is that they will be
adopted in 2014 and come into effect starting 2015.
For more information, see the EC's medical devices website.
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