June 02, 2021
Completing a process started about 13 years ago, new rules for how medical devices are evaluated and brought to market in the European Union (EU) came into full force last Wednesday with implications for everything from contact lenses to implantable cardiovascular devices.
In broad strokes, the updated Medical Devices Regulation (MDR) aims to enhance the quality and safety of medical devices by tightening up how they’re evaluated and certified ahead of market introduction; make the data used for approvals more transparent; improve postmarketing surveillance; and reduce administrative burdens on manufacturers.
“The legislation will strengthen innovation and our international competitiveness, ensuring that we are ready for any new and emerging challenges,” Stella Kyriakides, European Commissioner for Health and Food Safety, said in a press release announcing that the rules took effect.
EU Reporter
Published 42 seconds ago
New EU rules on medical devices (MDR) enter into application, establishing a modern and more robust regulatory framework to protect public health and patient safety. The new rules start applying after a one-year postponement due to the unprecedented challenges of the coronavirus pandemic, addressing the need for an increased availability of vitally important medical devices across the EU.
The Regulation covers medical devices ranging from hip replacements to sticking plasters. It increases transparency and brings EU legislation in line with technological advances and progress in medical science. It improves clinical safety and creates fair market access for manufacturers.
“This is an important step forward for the protection of patients across Europe. The new rules improve the safety and quality of medical devices while providing more transparency for patients and less administrative burden for businesses. The legislation will strengthen innovation and our international competitiveness, ensuring that we are ready for any new and emerging challenges.”
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Improves the quality, safety and reliability of medical devices: it imposes tighter controls on high-risk devices such as implants and requires the consultation of a pool of EU level experts before placing medical devices on the market. Clinical evaluations, investigations and the notified bodies that approve the certification of medical devices will be subject to tighter controls.
Photo by Darla Williams/ Getty Images
The EU’s new regulation on medical devices finally came into full application today, following a year’s delay due to the COVID-19 pandemic.
According to the European Commission, the Medical Devices Regulation (MDR) seeks to ensure a high level of public health and patient safety taking into account scientific progress.
The regulation entered into force in May 2017, replacing the Medical Devices Directive. This transition period helped to avoid market disruptions and some transitional provisions are in place until 2025.
In a statement on its website, the European Coordination Committee of the Radiological, Electromedical and Healthcare IT Industry (COCIR) welcomed the regulation, but raised concerns about the “plethora” of EU legislation that relates to medical devices.