The regulatory framework for medical devices in Europe is governed primarily by the following Regulations:
In 2017, the European Union published major revisions of its regulations governing medical devices and in vitro diagnostics to align with sector developments over the last 20 years. The new regulations, which entered into force in May 2017, aim to ensure a robust, transparent, and sustainable regulatory framework while maintaining a high level of safety and supporting innovation.
Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices replaced previous directives and provide transition periods for devices conforming to the old directives (Directive 93/42/EEC on medical devices and Directive 90/385/EEC on active implantable medical devices).
Regulation (EU) 2024/1860 amends the previous regulations to include a gradual roll-out of Eudamed, information obligations in case of supply interruptions, and transitional provisions for certain in vitro diagnostic medical devices (Directive 98/79/EC).
Regulation (EU) 2023/607 introduces a staggered extension of the transition period for medical devices and in vitro diagnostic medical devices, removing the “sell-off” deadline. Regulation (EU) 2022/112 allows for a progressive rollout of the IVDR, enabling a stepwise transition to the new regulation.
Unlike the previous Directives, which were transposed into national legislation, the MDR and IVDR are directly applicable in all EU Member States, thereby ensuring a more uniform application of medical device regulation across the EU.
In case of questions if a device is covered by the extended MDR transitional period, the EU Commission published a flowchart providing additional guidance.
More information is available here: New Medical Device Regulations – European Commission.
The SBA has also published a guidance document to help clarify some of the differences between the old MDD and the new MDR: Moving from MDD to MDR Guidance
