M/575 AMD 2 - Medical Devices (MDR-IVDR)
Medical devices in support of Regulation (EU) 2017/745 and in vitro diagnostic medicial devices in support of Regulation (EU) 2017746
Mandate M/575 AMD 2 relates to the development of European standards for medical devices and in vitro diagnostic medical devices to support the implementation of Regulation (EU) 2017/745 and Regulation (EU) 2017/746. It involves the approval or disapproval of the mandate, ensuring that harmonized standards align with the regulatory requirements set by these regulations. The mandate aims to facilitate compliance, enhance safety, and promote innovation in medical device markets across the EU by providing clear and consistent technical specifications through European Standardisation Organisations.
Purpose
The mandate M/575 AMD 2 relates to medical devices, aiming to support the implementation of two key European Union regulations: Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). These regulations establish the regulatory framework for ensuring the safety and performance of medical devices and in vitro diagnostic devices within the EU.
Standardisation request
This mandate requests the development or amendment of harmonised standards that align with the requirements set forth in Regulation (EU) 2017/745 and Regulation (EU) 2017/746. The standardisation activities should cover both the medical devices (MDR) and in vitro diagnostic medical devices (IVDR) sectors, reflecting any necessary updates or expansions in response to evolving regulatory or technological needs.
Expected deliverables
The deliverables expected under this mandate include harmonised European standards that can be used by manufacturers and other stakeholders to demonstrate conformity with the relevant EU regulations (MDR and IVDR). These standards serve as essential tools to facilitate compliance, support market access, and ensure the protection of public health by promoting high safety and performance standards for medical devices.
Context
Mandate M/575 was originally issued to support EU regulations governing medical devices and in vitro diagnostic devices. This amendment (AMD 2) indicates an update or revision process to the initial mandate, reflecting ongoing standardisation needs under the current regulatory framework. The decision on this mandate has been documented under resolution reference CEN/BT C090/2024, indicating formal consideration and (dis-)approval by CEN, the European Committee for Standardization.
The mandate covers standardisation work related to medical devices supporting Regulation (EU) 2017/745 and in vitro diagnostic medical devices supporting Regulation (EU) 2017/746. This includes products and sectors involving medical devices and in vitro diagnostic devices to ensure compliance with EU regulatory requirements.
General Information
Frequently Asked Questions
A European Standardization Mandate is a formal request from the European Commission to the European Standardization Organizations (CEN, CENELEC, and ETSI) to develop European standards (ENs) in support of EU legislation and policies. Mandates are issued under Regulation (EU) No 1025/2012 and help ensure that products and services meet the essential requirements set out in EU directives and regulations.
M/575 AMD 2 is a European Standardization Mandate titled "Medical devices in support of Regulation (EU) 2017/745 and in vitro diagnostic medicial devices in support of Regulation (EU) 2017746". Medical devices in support of Regulation (EU) 2017/745 and in vitro diagnostic medicial devices in support of Regulation (EU) 2017746 There are 282 standards developed under this mandate.
Standards developed in response to a mandate and cited in the Official Journal of the European Union become "harmonized standards". Products manufactured in compliance with harmonized standards benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation, facilitating CE marking and market access across the European Economic Area.