The legislation regarding medical devices in Europe is predominantly dictated by the European Union parliament. It applies to those countries which are part of the EU and also across the wider federation of the EEA.

European legislation is presented by way of Directives which are then adopted within the legislature of individual countries. The three key directives for medical devices are:

Medical Device Directive (MDD) - 93/42/EEC
Active Implantable Medical Devices (AIMD) - 90/385/EEC
In Vitro Diagnostic Medical Devices (IVD) - 98/79/EC

There are directives which amend the originals in specific areas.

Finally there are other Directives such as WEEE and REACH to name two, which also apply to medical devices.

Priory Analysts automatically advises clients on all Directives which impinge on medical devices.