Medical devices make an essential contribution to healthcare in the EU for the benefit of European citizens. From sticking plasters to X-ray scanners, dentures to hip joints and in-vitro diagnostic devices that monitor diabetes or identify infections, medical devices are crucial in diagnosing, preventing, monitoring and treating illnesses, and overcoming disabilities.
Medical devices within the EU are currently regulated by 3 directives:
- Council Directive 90/385/EEC on Active Implantable Medical Devices (AIMDD) (1990)
- Council Directive 93/42/EEC on Medical Devices (MDD) (1993)
- Council Directive 98/79/EC on in vitro Diagnostic Medical Devices (IVDMD) (1998)
On 5 April 2017, 2 new regulations on medical devices and in vitro diagnostic medical devices were adopted. They entered into force on 25 May 2017 and will progressively replace the existing directives. The new regulations should have been fully applicable in May 2020 for medical devices and May 2022 for in vitro diagnostic medical devices. Nevertheless, on 25 March 2020 the European Commission announced that work on a proposal to postpone the date of application for the Medical Device Regulation (MDR) for one year is ongoing. The decision was reached with patient health and safety as guiding principles and the main scope is to relieve pressure from national authorities, notified bodies, manufacturers and other actors and will allow them to fully focus on urgent priorities related to the coronavirus crisis.
More information is available here.