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.