What is a harmonised standard?

It is a European standard (EN) adopted by a European standardisation organisation at the Commission's request. When its reference is published in the Official Journal of the European Union under the MDR or IVDR, devices that conform to it are presumed to meet the requirements it covers.

Are harmonised standards mandatory?

No, their use is voluntary. But they give a presumption of conformity: departing from them obliges the manufacturer to demonstrate otherwise that the requirements are met, which the notified body examines in detail.

Where can the list of harmonised standards for medical devices be found?

In the implementing decisions published in the EU Official Journal (on EUR-Lex) and on the European Commission's harmonised standards page for medical devices, which summarises the references in force for the MDR and IVDR.

What is the difference between a harmonised standard and a common specification?

A harmonised standard is voluntary and gives presumption of conformity. A common specification, adopted by implementing act (MDR Article 9), is binding on the manufacturer unless it justifies a solution ensuring an at least equivalent level of safety and performance.

MDR and IVDR harmonised standards: what to know

Harmonised standards are the most widely used tool for demonstrating a medical device's conformity. They are also one of the main reasons regulatory monitoring is essential: every new publication decision can change the reference version. This guide explains how they work under the MDR and IVDR.

What a harmonised standard is

A harmonised standard is a European standard (EN) adopted by CEN or CENELEC at the request of the European Commission, under a standardisation request. For medical devices, this request covers the needs of the MDR and IVDR.

An EN standard is not harmonised merely by existing. It becomes harmonised under a regulation when the Commission publishes its reference in the Official Journal of the European Union, through an implementing decision.

Presumption of conformity

Article 8 of the MDR (and IVDR) sets the principle: devices that conform to harmonised standards whose references have been published are presumed to conform to the requirements of the regulation covered by those standards.

Three practical consequences:

Use remains voluntary. A manufacturer may demonstrate conformity otherwise, but must then fully justify it.
Presumption only applies to the requirements covered. Annex Z (ZA for the MDR, ZB for the IVDR depending on the standard) maps the standard's clauses to the Annex I general safety and performance requirements, with any limitations.
Presumption only applies to the published version. Another edition of the same standard gives no presumption until its reference is published.

How references are published

The first lists under the MDR and IVDR were published in 2021, then supplemented by successive implementing decisions. In June 2026, for example:

Implementing Decision (EU) 2026/1231 added new harmonised standards under the MDR, notably on biological evaluation, symbols and equipment;
Implementing Decision (EU) 2026/1313 published EN ISO 15223-1:2021, on symbols, under the IVDR.

Standards whose references are published include horizontal standards such as EN ISO 13485:2016/A11:2021 (quality systems), EN ISO 14971:2019/A11:2021 (risk management), EN ISO 15223-1:2021 (symbols) or EN 62366-1 (usability), as well as sterilisation, biological evaluation and product-family standards.

The Commission maintains a summary page of harmonised standards for medical devices. The authoritative source remains the Official Journal, on EUR-Lex.

When a standard is revised

When a new version of a standard is harmonised, the decision usually sets a date from which the old version no longer gives presumption of conformity. The manufacturer must then:

identify the devices whose conformity relies on the old version;
perform a gap analysis between the two versions;
update the technical documentation and, if needed, the device;
record the decision in its quality system.

This is exactly what MDR Article 10(9) targets: taking changes to harmonised standards into account "in a timely manner".

Non-harmonised standards and the state of the art

A non-harmonised standard gives no presumption of conformity, but it may represent the state of the art that Annex I requires to be taken into account. Notified bodies often expect recognised sector standards to be applied, or their non-application justified, whether harmonised or not.

Common specifications

Common specifications (MDR Article 9) are adopted by implementing acts where no harmonised standard exists or where it is insufficient. Unlike standards, they are mandatory: the manufacturer complies with them unless it justifies a solution ensuring an at least equivalent level of safety and performance. Common specifications exist, for example, for Annex XVI products without a medical purpose (Implementing Regulation (EU) 2022/2346), for certain class D in vitro diagnostic devices (Implementing Regulation (EU) 2022/1107) and for reprocessing single-use devices (Implementing Regulation (EU) 2020/1207).

How to monitor harmonised standards

Monitor the implementing decisions published in the Official Journal under the MDR and IVDR.
Follow draft standards for your device family (ISO and CEN enquiries), which signal upcoming revisions.
Keep a list of applied standards per device, with their version and harmonisation status.
Record each change in the monitoring log, with the resulting gap analysis.

MedQara reads ISO open data, Official Journal publications and Commission pages: every new standard, harmonisation decision and draft under enquiry that touches your scope is flagged. It is a pillar of medical device regulatory monitoring. You can also browse recent texts on our regulatory news page.

MDR and IVDR harmonised standards: presumption of conformity and monitoring

Key takeaways