MDCG 2021-5

MDCG 2021-5

MDCG 2021-5

MDCG 2021-5 – Guidance on standardization for medical devices

On July 2024 the EU Commission updated the MDCG document MDCG 2021-5 Rev.1. The document provides guidance on standardization for medical devices in the European Union. It covers various aspects related to standards in the medical devices sector to support the requirements set out in EU legislation.

Key points of MDCG 2021-5 Rev.1:

  1. Overview of EU legislation on medical devices under the “New Approach” and the “New Legislative Framework.”
  2. The general framework for harmonized European standards, including voluntary use of standards and the relationship between standards and EU legislation.
  3. Development and assessment of harmonized European standards for medical devices.
  4. Publication of references of harmonized European standards in the Official Journal of the European Union to confer presumption of conformity.
  5. International aspects of standardization and the concept of “state of the art” in relation to European standardization and conformity assessment for medical devices.
  6. Considerations on rulings of the Court of Justice of the European Union, European Pharmacopoeia, and common specifications.

For Legal Manufacturers:

This document serves as a valuable resource to understand the standardization requirements, navigate the EU legislation, and ensure compliance with the regulations governing medical devices in the European market. It provides insights into the harmonization process, conformity assessment, and the importance of following the state of the art in technology and medicine.

Conclusion:

Overall, this document aims to support manufacturers in meeting the necessary standards for medical devices, enhancing product quality, safety, and performance in alignment with EU regulations.

Source: MDCG 2021-5

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