European standards cited by reference in the Official Journal of the EU that give manufacturers a presumption of conformity with corresponding legal requirements.

Definition

A harmonised standard is a European standard developed by CEN, CENELEC, or ETSI at the European Commission's request under Regulation (EU) No 1025/2012, and subsequently cited by reference in the Official Journal of the European Union. Under MDR Article 8 and IVDR Article 8, devices that conform to the relevant parts of harmonised standards, or relevant parts thereof, are presumed to conform to the requirements of the Regulations covered by those standards, most commonly the General Safety and Performance Requirements in Annex I. The presumption is rebuttable: it applies only to the extent the standard's scope matches the applicable requirement and only for the version cited in the Official Journal, which may lag behind the latest published edition.

Why it matters

Post-MDR/IVDR, very few standards have been formally harmonised (cited in the OJEU) compared with the MDD/IVDD era, creating a gap where manufacturers rely on 'state of the art' standards without the legal presumption. The Commission's 2023 to 2025 batches of harmonised standard citations under Implementing Decisions have gradually restored coverage for ISO 13485, ISO 14971, IEC 60601 series, and IEC 62304, among others. Manufacturers must check the current OJEU list, since citing an un-harmonised edition of a standard does not confer the Article 8 presumption even if technically compliant.

Common pitfalls

•Assuming any published ISO or IEC standard automatically confers the Article 8 presumption of conformity; only versions formally cited in the OJEU do.
•Continuing to reference MDD/IVDD-era harmonised standard citations after MDR/IVDR application dates without verifying the standard has been re-cited under the new Regulations.
•Using the latest edition of a standard (e.g. a revised ISO 14971) while the OJEU citation still points to an older edition, creating a documentation mismatch during notified body review.

Sources

Regulation (EU) 2017/745, Article 8 · EUR-Lex
Regulation (EU) No 1025/2012 on European Standardisation · EUR-Lex
European Commission, Harmonised standards for medical devices (MDR) · European Commission

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Quality systems - QSR vs ISO 13485, QMSR vs QSR.
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