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New Medical Technology Regulations

Medical technologies are tightly regulated in the European Union. Before a medical technology can be legally placed on the EU market, a manufacturer must comply with the requirements of all applicable EU legislation and affix a CE mark to their device.

New EU Regulations governing medical devices (MD) and in vitro diagnostic (IVD) were published in May 2017. MedTech Europe is working with our members and the authorities to support companies in complying with the new legislation by the end of the transition periods – 2020 for MDs and 2022 for IVDs.

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How are medical technologies regulated today?

EU Directives have applied to medical devices (MD) and in vitro diagnostics (IVDs) since the 1990s. Two new EU Regulations were published in May 2017 governing the safety and performance of devices across their lifetime.

During a set of transition periods, manufacturers may choose to continue to comply with the applicable Directive or to opt for early compliance with the relevant Regulation. To complete the transition to the new regulatory system, Notified Bodies must be in place and a new electronic platform (Eudamed) must be operational. This work may not be completed until near the end of the transition period.

Regardless of whether a product is CE-marked under the Directives or the new Regulations, customers will continue to use medical technologies with a high level of quality, safety and performance; the hallmark of the EU CE-marking system.

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