MDCG Guidance on Standardization for Medical Devices

The Medical Device Coordination Group (MDCG) published the ‘Guidance on Standardization for Medical Devices’ (MDCG 2021-5) on April 16, 2021. Though none of the information presented is new material, it does provide a consolidated reference point perhaps most useful to those new to the industry. It is comprised of four sections and intended to explain the varying aspects and framework of the existing EU directives and regulations.

Sections 1 and 2 of the MDCG guidance covers much of the history and background details, as well as emphasizing that adherence to these standards is voluntary. They simply serve as a useful framework for achieving compliance with the actual legal requirements.  Section 2 also covers how the standards use Annex Z  to identify the contents that need to be covered, while pointing out the absence of MDR due to it not having been harmonized.

In Section 3 of the MDCG guidance, it covers the processes used to achieve harmonization from both a broad level as well as the medical device perspective. Here, it also speaks to one of the common issues facing manufacturers in deciding which standards should be applied:

  • those that address “state of the art” or
  • those that have been harmonized.

Though the latest version of standards may better reflect “state of the art”, they may not be the harmonized version that implies compliance with legal requirements. Until the latest versions become harmonized, manufacturers are encouraged to perform gap assessments using both.

For those interested, the MDCG guidance can be found MDCG_2021-5.pdf.

See our post regarding the 2019 update to ISO 14971: ISO 14971 Updated in 2019 Release

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  • Coverage of ISO 14971:2019, IEC 62304; amd1, and IEC/TR 80002-1.
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  • Why FMEA is incomplete for medical device risk management.
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