The Medical Device Coordination Group recently updated the guidance"Standardisation for Medical Devices" include points on topics including the European Pharmacopoeia and common specifications.
This guidance is intended for manufacturers, notified bodies, and other stakeholders involved in the lifecycle of medical devices and in vitro diagnostic medical devices.
It outlines how harmonised standards can be used to demonstrate compliance with legal requirements provides directions on various aspects of standards in the medical devices sector, supporting EU legislation requirements.
The EU's “New Approach” and “New Legislative Framework” establish the regulatory framework for medical devices, focusing on harmonised standards to ensure device safety and performance. These frameworks emphasize the importance of using harmonised European standards to meet essential requirements and facilitate market access.
Harmonised European standards are developed by recognised European Standards Organisations (ESOs), such as the European Committee for Standardisation (CEN) and the European Committee for Electrotechnical Standardisation (Cenelec), to support EU legislation. While the use of harmonised standards is voluntary, they provide a presumption of conformity with legal requirements, simplifying the conformity assessment process.
The development process involves multiple stakeholders, including manufacturers and notified bodies, to ensure the standards are practical and up-to-date. HAS consultants assess these standards for compliance with EU legislation.
Efforts are made to harmonise standards globally, working with international bodies like ISO and IEC, to facilitate international trade and regulatory convergence. Standards reflect the “state of the art” in technology and industry practices, ensuring that products meet current safety and performance benchmarks during conformity assessment.
Harmonised standards are essential for ensuring the safety and performance of medical devices in the EU. They provide a clear framework for compliance, facilitate market access, and reflect the latest technological advancements. Stakeholders are encouraged to participate in the standardisation process to ensure the standards remain practical and relevant.
For more detailed information, refer to the full document: Guidance on Standardisation for Medical Devices.
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