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Commission publishes information notice on the status of the EU-Switzerland Mutual Recognition Agreement for Medical Devices

Today, the Commission has published a notice to stakeholders informing them that the mutual recognition and related trade facilitating effects for medical …

Public health: Stronger rules on medical devices | EU Commission Press

Public health: Stronger rules on medical devices | EU Commission Press
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Questions & Answers: Application of Regulation on Medical Devices - EU rules to ensure safety of 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.

Application of Regulation on Medical Devices - EU rules for safety of medical devices — EUbusiness com

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. Advertisement 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

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