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 – 2021 for MDs and 2022 for IVDs.
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.
New IVD symbols for compliance with the IVDR
By 26 May 2022, IVD devices will transition to the new IVD Regulation EU 2017/746. This regulation will require devices intended for self-testing, devices intended for near-patient testing and certain rapid tests (not for self-testing and not for near patient testing) to state these facts on their labels.
Training and Education
The system for ensuring that medical devices meet the necessary standards, specifications, quality, safety and performance requirements is complex. Understanding EU legislation, they key regulatory actors and the essential steps in the CE marking system is vital to bringing products to market.
Our members are currently managing four- and five-year transition periods to the new regulations. This presents considerable uncertainties that need to be reduced through, for example, practical explanations of what companies can and cannot do over the coming years. It is also essential that we flag our concerns about the feasibility of the transition periods to the authorities.
Notified Bodies are responsible for assessing and (re-)certifying most MDs and IVDs, allowing products to be placed on the market. Both new regulations introduce new obligations for Notified Bodies and will require the assessment of more products than ever before. For example, 35,000 IVDs will be covered by Notified Bodies for the first time.
Posted on 13.07.2023