On January 4, the European Commission recognised nine harmonised standards for medical devices that manufacturers can reference in order to satisfy conformity requirements under the Medical Devices Regulation (MDR 2017/745).

These standards follow an earlier set of five standards that the commission recognised in July 2021, bringing the total number of harmonised standards to fourteen.

Harmonised standards

Harmonised standards are a kind of elaboration on parts of – in this case – the MDR, helping manufacturers to comply with the MDR more easily and quickly. The MDR is limited to establishing essential requirements that medical devices intended to be placed on the EU market must meet. The technical details and solutions supporting those essential requirements are laid down in harmonised European standards.

When a harmonised standard has been approved and published by the European Commission and a medical device is in conformity with that standard or the relevant parts of that standard, the device is presumed to be in conformity with the MDR. If a manufacturer uses harmonised standards, the conformity assessment procedure of the device concerned will therefore be much faster and more efficient.

However, manufacturers are not obliged to use harmonised standards. In general they are allowed to use other standards or develop their own technical solutions, provided that they must be able to demonstrate that these alternatives meet the requirements of the MDR.

Harmonised standards under the MDR

The fourteen standards cover topics including the biological evaluation of medical devices, sterilisation, aseptic processing, quality management systems, the use of symbols in product information, and more. They apply to a wide variety of medical devices:

More information?

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