M/432 - Medical Devices
Standardisation Mandate addressed to CEN and CENELEC within the framework of Directive 2007/47/EC amending Directive 90/385/EEC and Directive 93/42/EEC relating to Medical Devices
Mandate M/432 addresses the standardisation of medical devices in response to Directive 2007/47/EC, which amends Directives 90/385/EEC and 93/42/EEC. It tasks CEN and CENELEC with developing harmonised standards to support the implementation of these directives, ensuring improved safety and performance of medical devices. This mandate focuses on aligning European standards with updated regulatory requirements, facilitating compliance and market access for manufacturers. The decision on the mandate was recorded under resolution CEN/BT C2/2009.
Purpose
This mandate addresses the development of harmonised standards for medical devices in the context of Directive 2007/47/EC, which modifies earlier directives 90/385/EEC and 93/42/EEC related to medical devices. The objective is to support the effective implementation of these directives through standardisation, ensuring safety and performance requirements for medical devices within the European Union.
Standardisation request
The mandate is addressed to the European standardisation organisations CEN (European Committee for Standardisation) and CENELEC (European Committee for Electrotechnical Standardisation). It requests these bodies to draft, review, and update relevant harmonised standards that align with the amended legislative provisions set out in Directive 2007/47/EC. The focus is on standards that facilitate conformity assessment and regulatory compliance for manufacturers and stakeholders in the medical device sector.
Expected deliverables
Deliverables are anticipated to include:
- Updated or new harmonised European standards reflecting amendments introduced by Directive 2007/47/EC to Directives 90/385/EEC and 93/42/EEC.
- Documentation facilitating the assessment of medical device conformity under the revised regulatory framework.
- Coordination and consultation processes involving relevant stakeholders to ensure comprehensive and consensus-based standards.
Context
Directive 2007/47/EC amends key EU legislation governing the placing on the market and the putting into service of medical devices. These directives aim to protect health and safety while enabling the smooth functioning of the internal market. Harmonised standards developed under this mandate support manufacturers in meeting legal requirements and help notified bodies in conformity assessment procedures. This mandate reflects the ongoing standardisation efforts necessary to adapt to evolving regulatory conditions in the medical device sector.
This mandate covers the development of European standards for medical devices, including active implantable medical devices and other medical devices as defined under Directive 90/385/EEC and Directive 93/42/EEC. The scope includes ensuring harmonized standards to support compliance with safety, performance, and regulatory requirements for medical devices within the EU market.
General Information
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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/432 is a European Standardization Mandate titled "Standardisation Mandate addressed to CEN and CENELEC within the framework of Directive 2007/47/EC amending Directive 90/385/EEC and Directive 93/42/EEC relating to Medical Devices". Standardisation Mandate addressed to CEN and CENELEC within the framework of Directive 2007/47/EC amending Directive 90/385/EEC and Directive 93/42/EEC relating to Medical Devices There are 0 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.