MDCG guidance on standardisation for medical devices

The MDCG document pursues to provide guidance on several features related to standards in the medical devices industry supporting the requirements set down in the applicable European legislation considering its specificities.

The contents of this guidance include:

  1. EU legislation on medical devices, consisting of three current Directives and two new Regulations. In this type of legislation, the role of harmonised European standards is essential since it establishes essential requirements that products intended to be sold on the EU market should meet.
  2. General framework for harmonised European standards, including specific legal and guidance reference supporting the European harmonisation legislation, the voluntary use of standards, and the relationship between harmonized EU standards and EU legislation (the annex Z).
  3. Harmonised European standards in support of the EU legislation on medical devices, containing the following references:
    • Specific provisions and the presumption of conformity granted by its voluntary use,
    • EU standardisation organizations in charge of the development of harmonised standards in the healthcare engineering industry (CEN for most types of medical devices and Cenelec for medical electrical equipment),
    • Standardisation mandates or requests,
    • Assessments by the harmonised standards consultants,
    • Publication of the references to such standards in the OJEU,
    • International standardisation developed by ISO and IEC, and the IMDRF voluntary group which promotes international and regional regulatory harmonisation, and
    • The concept of “state of the art” to comply with the health, safety, and performance requirements.
  4. Governance structure for standards in the medical devices sector ruled by the MDCG subgroup on standards devoted to standardisation issues and the CEN-Cenelec Advisory Board on Healthcare Standards, a forum for medical devices aiming to bring together EU stakeholders interested in or affected by standardisation in the healthcare industry.

These contents are not exhaustive and should be interpreted within the legal and guidance framework on European harmonisation legislation for health, safety, and performance of products in the internal market.

You can find the full text of the most recent MDCG Guidance in our Library of documents – MDCG or Library of Documents – STANDARDS.

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