On 5 April, the European Parliament (“Parliament”) adopted the Package on medical devices. It consists of two Regulations: the Regulation on medical devices and the Regulation on in vitro diagnostic medical devices. The final texts are the result of a long negotiation process started in 2012, after the Commission’s proposals were presented, and of a wide expert consultation, which resulted in an agreement among Member States' health ministers on 5 October 2015.
The overhaul revises the existing legislative framework on safety and performance of medical devices dating back to the ‘90s, with the purpose of improving the market oversight framework, ensuring a harmonized regime on medical and in vitro diagnostic devices and that these reflect technological and scientific progress/development. The Regulations will apply to all medical devices, in vitro medical devices and their accessories, as well as to certain aesthetic products, previously unregulated.
The reform introduces stricter controls on clinical trials and on notified bodies. For high-risk devices, notified bodies will be required to consult a new Medical Device Coordination Group (“MDCG”) before their commercialization. These panels, composed by Member States experts and headed by the Commission, will release non-binding scientific opinions on the assessment of the medical devices. In case notified bodies choose not to follow them, they will need to provide a justification for their decisions, which will be published on a EU Database on medical devices, to be set up by the Commission by 2020 and providing a picture of the products available in the European market.
Furthermore, pre-market conformity assessment procedures will be carried out in line with a new risk classification system, which organizes medical devices and in vitro medical devices into four categories in accordance with international guidelines.
The Regulations impose on manufacturers the obligations to collect clinical evidence of the performance of devices available on the market and to adopt a sound financial mechanism able to compensate patients receiving defective products. These financial compensation systems shall be proportionate to the type of device, its risk class and the size of the company.
Concerning the registration of devices and operators, currently required in all Member States where products are commercialized, it will need to be done only once at the EU level, significantly reducing the red tape.
Following the entering into force of the Regulations, certificates issued under the current Directives will remain valid for an additional period of time, which is of three years for the Regulation on medical devices and of five years for the Regulation on in vitro diagnostic medical devices.