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MedTech Europe warns that until challenges are resolved, roadblocks will continue to limit the sector’s ability to seamlessly supply certified devices under the new rules.
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.
Met dank overgenomen van Europese Commissie (EC), gepubliceerd op woensdag 26 mei 2021.
1.
Why do we need new rules on medical devices?
The EU rules on the safety and performance of medical devices were created in the 1990s. To reflect the substantial technological and scientific progress in this sector over the last 20 years, the Commission has proposed to update the rules to improve the safety of medical devices, with a view to modernise the sector and to consolidate the EU s role as a global leader in this area.
The Medical Devices Regulation entered into force in May 2017 and becomes applicable on 26 May 2021. This transition helped to avoid market disruptions. Several transitional provisions are in place until 2025.
Info
26 May 2021
by eub2 last modified 26 May 2021
As of 26 May, 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.
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1. Why is there a need for new rules on medical devices?
The EU rules on the safety and performance of medical devices were
created in the 1990s. To reflect the substantial technological and
scientific progress in this sector over the last 20 years, the
Commission has proposed to update the rules to improve the safety of
medical devices, with a view to modernise the sector and to consolidate