New framework for European medical device regulations

European Union regulations that date back to the 1900’s are currently under reform.

At present medical devices are regulated under three separate directives that have provided a relatively stable framework for around a century. However, in the wake of controversial news headlines, such as the PIP breast implants scandal, a new regulatory framework is currently making its way through the European Parliament and Council.

The European Commission have proposed a new framework which will replace the three existing directives with two new ones, one covering medical devices (MDs) and the other on in-vitro medical devices (IVMDs).

The idea of change was first debated in May 2008 when a European consultation on medical devices was launched and resulted in proposals about new framework. These proposals have been working their way through the European legislature process ever since.

The aims of the proposals are to increase transparency, to restore public confidence in medical devices and to harmonise law in the European Union.

Stricter regulation and the conversion of three directives to two device regulations should reduce inconsistencies between Notified Bodies. The UDI implementation and the Eudamed database expansion are designed to increase device safety but unannounced audits and a robust scrutiny process will only increase costs for manufacturers. A 2013 survey by the trade group Eucomed forecast an estimated cost of £12.4 billion as a result of the proposed regulations. With the EU still feeling the effects of the financial crisis political pressures may force yet further revisions for the implementation costs of the regulations which aim to restore public confidence in all devices, but will increase costs for manufacturers.

So far the European Parliament has adopted its first reading position of the draft proposals but as with all European legislation, the European Council must also adopt its common position and this is expected to follow sometime this year. However, the process is not a fast one and implementation is not expected until sometime between 2015 and 2019.