Medical Device Standards: FDA Recognized Consensus Standards and EU Harmonised Standards

Standards are the shared language of medical device regulation. Regulators rarely tell you exactly how to test a device; they tell you what outcome you must achieve and let standards describe how to do it. Using the right standards, and recording your use of them correctly, can shorten reviews in the US and the EU, while using them carelessly can cause deficiency letters and audit findings. This guide explains how FDA recognises consensus standards, how the EU system of harmonised standards works, and how to build a standards plan that serves both markets.

The US system: FDA recognised consensus standards

FDA maintains a database of recognised consensus standards published by organisations such as ISO, IEC, ASTM and AAMI. Recognition means FDA considers conformity to the standard, or parts of it, to be a suitable way to address a relevant requirement. Recognition can be full or partial, and it can be limited to specific parts or to the purposes stated in the database.

• Declarations of conformity: in a 510(k), De Novo or PMA you can declare conformity to a recognised standard, supply the required statements and, where relevant, include the test summary, so FDA does not need to review the full test report.
• Standards data reports: FDA expects a structured record of the standards used, including the version, whether you fully or partly comply and any deviations.
• ASCA program: the Accreditation Scheme for Conformity Assessment lets accredited laboratories test to selected standards so FDA can accept results with greater confidence. Check which standards are in scope, for example for basic safety and essential performance, electromagnetic compatibility and biocompatibility.
• Quality system link: since 2 February 2026 the QMSR incorporates ISO 13485:2016, which is a clear example of a standard made part of a regulation. See the QMSR implementation checklist.

For how the evidence enters the submission, see the 510(k) submission process and the PMA guide.

The EU system: harmonised standards

Under the MDR and IVDR, devices that conform to relevant harmonised standards, whose references have been published in the Official Journal, are presumed to conform to the requirements the standards cover. Harmonised standards are developed by the European standardisation bodies (CEN and CENELEC) at the request of the Commission. Important points:

• The presumption is only for the requirements the standard actually covers. The annexes (known as Annex Z or ZA) of the European version show the link to the general safety and performance requirements.
• Not all useful standards are harmonised. Using a non-harmonised standard is allowed, but you must demonstrate how it meets the requirement.
• Harmonisation under the MDR and IVDR has been gradual, and the list of cited standards changes. Check the current Official Journal list rather than relying on an older table.
• Common specifications may be adopted by the Commission where harmonised standards are missing or insufficient, and they must be followed unless you justify an equivalent solution.

Standards that most manufacturers need

Topic	Standard	Where to read more
Quality management system	ISO 13485	ISO 13485 and QMSR training
Risk management	ISO 14971	Risk management
Usability	IEC 62366-1	Usability engineering
Software lifecycle	IEC 62304	IEC 62304 guide
Electrical safety and EMC	IEC 60601-1 and collateral standards	IEC 60601 guide
Biological evaluation	ISO 10993 series	Biocompatibility
Sterilisation and packaging	ISO 11135, ISO 11137, ISO 17665, ISO 11607	Sterilisation and packaging
Clinical investigation	ISO 14155	IDE and clinical studies
Symbols and labelling	ISO 15223-1, ISO 20417	Device labelling

Building a standards plan

1. List applicable standards early, from your intended use, device type and the regulations of each target market.
2. Check the recognised or harmonised edition in FDA’s database and the Official Journal, and the scope of recognition.
3. Map standards to requirements: to FDA expectations and to the MDR general safety and performance requirements, in a table you keep with the technical file.
4. Define the evidence: which tests, by whom, to which clauses, with what acceptance criteria. Use accredited laboratories and, in the US, consider ASCA where applicable.
5. Record deviations and justifications. If you do not meet a clause, document why and how the risk is controlled.
6. Watch for changes. Put standards monitoring in your quality system, with a review of impact when a new edition is recognised or harmonised. See change control.

Common mistakes

• Testing to a newer edition than the one the regulator recognises, or to an older one that is no longer accepted.
• Claiming conformity to a whole standard when only part applies or when tests were done to part of it.
• Assuming a harmonised standard covers every relevant requirement.
• Relying on a supplier’s report without checking the test method, sample and laboratory scope.
• Forgetting to update the declaration when the standard or design changes.
• Ignoring national differences when entering new markets. See global market access.

Frequently asked questions

Is following a standard mandatory?

Standards are voluntary, but using recognised or harmonised ones is the simplest way to show conformity. If you choose another method, you must show that it meets the requirement.

Does a harmonised standard guarantee CE marking?

No. It gives a presumption of conformity for the requirements it covers. You still need risk management, clinical evaluation, a quality system and the conformity assessment route for your class.

What if a standard changes during my project?

Check the transition rules in the regulator’s database or list. Where a new edition is recognised, decide whether your evidence remains valid, needs a gap analysis or must be repeated.

Can I use the same test reports in the US and EU?

Often, if they were done to a standard accepted by both and the scope and acceptance criteria match. Check each regulator’s recognised edition and any extra expectations.

Recognition and harmonisation lists change regularly. Confirm the current status in FDA’s recognised standards database and the Official Journal list before relying on a standard in a submission.

Related reading

• US FDA medical device regulations: where standards fit in submissions.
• EU medical device regulations: GSPR and conformity.
• EU MDR technical documentation: how to present standards evidence.
• Design controls: linking standards to design inputs and verification.

Talk to the AptSkill team

Need help building a standards plan or training your team? Send us your role and goal.