The EU Parliament has adopted the proposal for the Medical Device Regulation, which will replace the current Medical Device Directive (93/42/EEC) and Active Implantable Medical Device Directive (90/385/EEC).
The final text will be published in the Official Journal of the European Union in May, and the Regulation will enter into force 20 days later. This will be the start of a three year transition period for manufacturers to meet the new requirements.
This long awaited text brings with it more scrutiny of technical documentation; it addresses concerns over the assessment of product safety and performance by placing stricter requirements on clinical evaluation and post-market clinical follow-up, and requiring better traceability of devices through the supply chain.
Read the full EU Commission press release here
The start of this long process of change occurred on 26 September 2012, when the European Commission adopted a Proposal for a Regulation of the European Parliament and of the Council on medical devices and a Proposal for a Regulation of the European Parliament and of the Council on in vitro diagnostic medical devices, which replaces the existing three Medical Device Directives.