MDCG 2021-5 Rev. 1: Guidance on Standardisation for Medical Devices

The EU legislative framework on medical devices is outlined in a guidance document endorsed by the Medical Device Coordination Group (MDCG). This document underscores the voluntary use of harmonized European standards, which offer a presumption of conformity with EU legislation and contribute to transparency and legal certainty.

The guidance highlights that while manufacturers are encouraged to use harmonized standards to demonstrate compliance, it is not a mandatory requirement. The document references the "Orona" case, which clarifies that manufacturers have the option to use alternative solutions for achieving harmonization, should they choose not to follow the harmonized standards.

Additionally, the European Pharmacopoeia is mentioned as a source of official quality standards for medicines and materials used in medical devices. When these standards are cited in the Official Journal of the European Union (OJEU), they confer a presumption of conformity.

Common specifications are discussed as an alternative to harmonized standards. These technical and/or clinical requirements are utilized to meet legal obligations for medical devices, especially when harmonized standards are either inadequate or unavailable.

The guidance also acknowledges the work of the International Medical Device Regulators Forum (IMDRF) in developing international standards, further supporting the global consistency and quality of medical devices.

Source: https://health.ec.europa.eu/document/download/59ac4cb0-f187-4ca2-814d-82c42cde5408_en?filename=md_mdcg_2021_5_en.pdf##~https://health.ec.europa.eu/latest-updates/update-mdcg-2021-5-rev1-guidance-standardisation-medical-devices-july-2024-2024-07-02_en

Region: European Union