What is the purpose of harmonised standards for medical devices and are they state of the art?
According to the EU Medical Devices Regulation 2017/745 (MDR), harmonized standards are used by manufacturers to help demonstrate conformity with the General Safety and Performance Requirements (GSPRs) and other legal requirements, such as quality or risk management. These standards cover a range of subjects including management systems, test methods, sterilisation procedures and even software lifecycle processes.
‘State of the art’ refers to what is generally accepted as the current best practices and technologies. This does not means that is the latest version of a standard. Sometimes an older version of a standard may still represent the current best practice, depending on its adoption and applicability, and be considered as the state of the art.
Are harmonised standards only for the EU?
Harmonized standards are not enforceable outside of the EU, however they are recognised and/or utilised by some other countries, such as Switzerland and the UK. In both countries, specific harmonised standards are designated by the competent authorities and published in the Federal Gazette or Designated Standards List, respectively. The USA has its own system of recognised consensus standards.
How to know if a standard is harmonised and where to find them?
The only way to know if a standard has been harmonised, is if it appears in the Official Journal of the European Union (OJEU). The harmonised standards are also prefixed “EN”.
Whilst the OJEU has a list of the harmonised standards, the full text versions are not available to purchase. Harmonized standards can be purchased from EU national standardisation bodies (e.g. DIN in Germany, NSAI in Ireland). Although the cost differs between the bodies, the content is
largely the same and can be used in all EU member states, as well as the European Economic Area (EEA). The same applies where the UK has designated an EN standard – copies from any EU national standardisation body suffice.
Are Harmonised Standards Mandatory?
Use of harmonised standards is covered in article 8 of the EU MDR. It states that compliance with relevant harmonised standards confers a presumption of conformity with the regulation’s requirements. However, their use is not mandatory. Where manufacturers choose to use other procedures or methods to demonstrate that the GSPRs and other requirements are met, they must be prepared to justify their rational with sound reasoning and clear documentation.
What to do if there is new version of standard, but hasn’t been harmonised yet?
Periodically standards will be updated, but any updated versions of standards are not automatically harmonised. When a new version is released, manufacturers have 2 options:
- Continue using the harmonised version
- Adopt the new standard
In both cases, the newest version of the standard should be reviewed and a gap analysis created so that the impact of any changes can be assessed and a full, documented justification for the decision of which standard to use is recorded.
What is different about harmonised standards?
Whilst the core content of a harmonised standards generally mirrors the original published version of the standard, there are a two key differences:
- A European or national forward describing the harmonisation process and may contain country-specific details.
- ‘Z’ Annexes mapping the standard clauses to relevant EU legislation. For instance, in EN ISO 13485, the Z annexes show how the standard correlates to the QMS requirements in the EU MDR and EU IVR. Some standards will also have the ‘NZ’ annex. This is a national annex, which will show the differences between the standard and the national laws from the country that published that version of the standard.
Structure of ISO standards
National/European Forwards
The forwards in harmonised standards, will often contain information about the process of harmonization and the committees that approved or prepared that version. They may also contain extra requirements that can be country specific.
Introductions:
The introduction in a standard is optional. It can add background information or commentary, but it will not contain any requirements.
Scope
The scope in a standard is mandatory. The scope explains what the standards does and where it is applicable. It will only contain factual statements and cannot contain any requirements or recommendations.
Annexes
There are two types of annexes:
- Normative annexes are mandatory and give additional requirements.
- Informative annexes give additional information and guidance. You can choose whether to follow informative annexes or not; however, it is good practice to provide a justification as to why you are not following informative annexes.
The annexes are used to separate out information that might not be appropriate in the body of the text and are cited in the document.
Language
Standards are written in plain language, to make it easier to read and understand, and avoid misinterpretation. At the start of ISO standards, they tell you about the verbal forms which are used in the standard and how the words should be interpreted:
Shall – Requirement (You must comply with this)
Should – Recommendation
May – Permission
Can – Possibility or capability.
What’s is the difference between common specifications and harmonised standards for medical devices?
Common Specifications (CS) was a new term that was introduced in the EU MDR to describe documents to fill gaps for products where no harmonised standards exist, or the existing harmonised standards are not sufficient. Like harmonised standards, CSs can be used to demonstrate presumptive conformity with the regulatory requirements of the EU MDR.
Conclusion: Leveraging harmonised standards for medical devices effectively
Harmonised standards for medical devices are a cornerstone of regulatory compliance within the EU framework. While their use is not mandatory, they provide a powerful and efficient way for manufacturers to demonstrate conformity with essential requirements under the EU MDR and
IVDR. Understanding how to identify, access, and interpret these standards—particularly their structure, annexes, and legal relevance—can make the difference between basic compliance and a robust, future-proofed quality system.
Whether you’re navigating horizontal standards like EN ISO 13485 or vertical product-specific ones, aligning your approach with harmonised standards ensures consistency, clarity, and regulatory confidence. By staying informed about updates and effectively managing transitions between versions, your organisation can turn these standards from a checklist into a strategic advantage.
