MDR harmonized standards: April 8, 2025 update, what manufacturers need to remember

Medical devices regulation

11 April 2025

In a regulatory world as fluid as that of CE marking for medical devices, the publication of new harmonized standards deserves your full attention. On April 8, 2025, the European Commission adopted Implementing Decision (EU) 2025/681, amending the list of harmonized standards applicable under Regulation (EU) 2017/745 (MDR).

This text, although technical and little commented, has concrete consequences for manufacturers. In particular, it concerns three families of frequently encountered products or processes: single-use medical gloves, device sterilization and ambulance equipment for patient transport.

Here's what you need to bear in mind, and especially what it means for your technical files.

1. Reminder: what is the purpose of a harmonized standard?

A harmonized standard is a European standard whose reference is published in the Official Journal of the European Union. When a manufacturer applies a relevant harmonized standard in full, he enjoys a presumption of conformity with the requirements covered by the MDR.

In plain English: if your technical file is based on these standards, you don't need to demonstrate yourself how you comply with certain points in Annex I of the MDR. This saves time... and provides a safety net in the event of an audit or CE assessment.

Be careful, however:

A harmonized standard is never mandatory,
But if you don't use it, you'll have to demonstrate, with solid arguments, that your solution is at least equivalent.

Finally, applying an old version of a harmonized standard that has been superseded may expose you to remarks from the notified body.

2. What Decision 2025/681 changes

The decision amends the annex to implementing decision (EU) 2021/1182 by adding 6 new harmonized standards, some of which are updates of existing standards. Here is the summary:

Harmonized standards added to the Official Journal

Reference	Subject	Key evolution
EN 455-1:2020+A2:2024	Disposable medical gloves - Hole detection	Addition of enhanced detection requirements
EN 455-2:2024	Single-use medical gloves - physical properties	Mechanical testing updated
EN 556-1:2024	Sterilization - terminally sterilized devices	Revision of validation requirements
EN 556-2:2024	Sterilization - aseptic processing	Clarification of performance criteria
EN 1865-2:2024	Ambulance equipment - motorized stretchers	Harmonization with recent safety requirements
EN 1865-6:2024	Ambulance equipment - motorized chairs	New standard, MDR support

These standards came into force on publication in the Journal Officiel on April 9, 2025.

3. What are the implications for DM manufacturers?

Case study 1 - Manufacturer already applies EN 455-1:2020

He must compare the addition of amendment A2:2024 and check that his quality controls comply with the new version. If not, an update of the inspection plan and technical file is required.

Case study 2 - The manufacturer was still using a pre-MDR standard

The risk is real. The use of a MDD (non-harmonized MDR) standard gives no presumption of conformity. An audit may require detailed justification.

Case study 3 - The manufacturer ignores this update

In a post-market surveillance context, a problem with gloves, sterilization or transport equipment could expose the company to legal or insurance consequences, especially if a harmonized standard was available but ignored.

4. Mini FAQ

Can I continue to use a previous version of a harmonized standard?

No, unless it is still listed in the Official Journal. As soon as a new version replaces an old one, the latter loses its harmonized status.

Do I have to review my entire technical file?

No, but you do need to assess the impact of each new version on your products. This can take the form of a simple watch note, or an update of the STED/Annex II-III.

Is it retroactive?

No. DMs already on the market are not affected, but any modification, renewal or new declaration must be made using the updated standards.

How can I be notified of future updates?

By following the updates to Decision 2021/1182, available online via EUR-Lex, or by using a delegated regulatory watch (like the one offered by CSDmed).

Can I freely access these standards now?

Not yet, but the CJEU recently recognized in case C-588/21 P that there is an overriding public interest in allowing access to harmonized standards. This point could change the conditions of access in the coming months.

5. Integrating standards into your quality strategy

Harmonized standards are more than just technical references. They are at the heart of your MDR compliance, and updating them should be anticipated rather than imposed.

At CSDmed, we help manufacturers to:

Monitor these changes in standards,
Analyze their impact on existing products or those under development,
Update technical files in a coherent and well-founded manner.

Need support with your standards, compliance reports or validation protocols?

6. Related resources

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