Medical Devices

Since 2010 HOPE is a member of the European Commission Expert Group on Medical Devices (MDEG). The group is composed of industry and other stakeholders’ representatives in the area of medical devices and discusses issues related with the implementation of the Medical Devices Directive. Additionally, HOPE is also part of its Unique Device Identification (UDI) Working Group.

Following the launch, in 2010, of a public consultation on the revision of the Directive on in vitro diagnostic medical devices to which HOPE responded, the European Commission published in 2012 two proposals of revised Regulations on medical devices and in-vitro diagnostic medical devices. Both texts were adopted in 2017 by the Council (March) and the European Parliament during plenary (April).

The agreed texts have been largely welcomed by stakeholders and the public. Increased safeguards against counterfeit devices and traceability will be guaranteed both in the pre-and post-market stages thanks to the introduction of systems such as Unique Device Identification (UDI). However, the core system of pre-market scrutiny of medical devices will still be based on decisions made by Notified Bodies, thus private companies, rather than public authorities as is the case for pharmaceuticals.

HOPE closely monitored the legislative process in the European Institutions and advocated that, when done in a safe way, the re-use of medical devices is a way to reduce costs and contribute to the protection of the environment. Reprocessing of medical devices results in the reduction of procurement costs, better use of cleaning and sterilisation equipment and in the reduction of inventory, waste and overall consumption of raw materials and primary energy.

Following the agreement on the draft Regulations, HOPE published a document summarising the main provisions of the coming legislation, with emphasis on the changes that will extensively influence hospital activities.

The new rules will apply three years after publication as regards medical devices and five years after publication as regards in vitro diagnostic medical devices. During this period, HOPE keeps monitoring and actively contributes to the transposition process of the regulations into the Member States national legislation as well as the Implementing Acts set by the European Commission.