Medical Devices Regulation: EU takes action to facilitate continued availability of certain low-risk medical devices to patients and healthcare systems
Brussels, 18 December 2019 – With the approval by the European Parliament yesterday, the European Union (EU) has brought additional clarity regarding the transitional provisions of the Medical Devices Regulation (MDR).
Posted on 18.12.2019
The European Parliament approved a measure initiated by the European Commission and approved by all Member States that clarifies the new regulatory framework for medical devices. This enables certain existing and critical low-risk devices - such as reusable scalpels, scissors, forceps and drill bits - to leverage the same transitional measures that exist for many other medical devices.
This measure ensures that devices remain available to patients, provided that these devices are lawfully CE marked before 26 May 2020, in accordance with the rules of the current Medical Device Directive. By no later than 26 May 2024, these devices must be fully transitioned to the new rules, which include the requirement for certification by a Notified Body. This facilitates the transition to the new Regulation with minimal disruption for patients and healthcare systems while the new regulatory system is still being built.
MedTech Europe also recognises the exchange at the EPSCO Council meeting on 9 December 2019 on the MDR, where Member States agreed that the regulatory system is not ready yet, and that much effort is still required to deliver a functional system by the regulatory deadlines. This should be addressed by a ‘readiness check’ that the EPSCO Council assigned to the European Commission and to the national competent authorities in the Medical Devices Coordination Group (MDCG).
The medical technology industry remains committed to working with all EU institutions and authorities, to help prevent a “cliff-edge” scenario for patients, healthcare professionals, and healthcare systems in Europe.
About MedTech Europe
MedTech Europe is the European trade association for the medical technology industry including diagnostics, medical devices and digital health. Our members are national, European and multinational companies as well as a network of national medical technology associations who research, develop, manufacture, distribute and supply health-related technologies, services and solutions.