European Union, 20 October 2025 — The European Commission has released Implementing Decision (EU) 2025/2078, updating the list of harmonised standards under the EU Medical Device Regulation (MDR 2017/745). This decision introduces newly revised standards that medical device manufacturers must adopt to maintain the presumption of conformity for their products within the MDR framework.
New EU Harmonised Standards Introduced for Medical Devices
The 2025 Decision includes references to the following updated standards:
- EN 13795-1:2025 – Surgical drapes and gowns – Requirements and test methods
- EN 13795-2:2025 – Clean air suits – Requirements and test methods
- EN 14683:2025 – Medical face masks – Requirements and test methods
- EN 14180:2025 – Low-temperature steam and formaldehyde sterilizers – Requirements and testing
These standards replace earlier harmonized versions previously listed under MDR 2017/745.
The Importance of the Latest MDR 2017/745 Compliance Update
Once published in the Official Journal of the European Union (OJEU), the new standards will officially confer presumption of conformity. Manufacturers relying on older versions, such as EN 13795:2019 or EN 14683:2019, will need to revise their testing reports, documentation, and Declarations of Conformity to meet the updated criteria.
The changes primarily affect manufacturers and suppliers of:
- Surgical drapes, gowns, and cleanroom garments
- Medical face masks
- Low-temperature steam and formaldehyde sterilizers
How Manufacturers Should Respond to the EU 2025/2078 Update
To ensure continued compliance with MDR 2017/745, Morulaa Healthtech recommends the following steps:
Conduct a Gap Assessment
Review current evidence, test data, and technical files against the updated 2025 requirements. Identify new performance parameters or modified test methods that require revalidation.
Update Verification and Validation Records
If test limits or methodologies have changed, conduct retesting and update all relevant documentation, including verification and validation reports.
Revise Declarations and Labelling
Ensure that Declarations of Conformity, Instructions for Use (IFUs), and all product documentation reference the 2025 editions of the harmonized standards.
Engage Your Notified Body
Notify your Notified Body of the updates made to your conformity assessment documentation, especially if the revised standards are included within your certification scope.
Review Supplier and Material Compliance
Confirm that suppliers of fabrics, filtration materials, and sterilization systems also comply with the updated standards to prevent downstream non-conformities.
Effective Date
The Decision took effect immediately upon publication on 20 October 2025. Although no formal transition period has been defined, manufacturers are encouraged to adopt the new standards promptly to maintain seamless MDR compliance.
How Morulaa Healthtech Supports Manufacturers
At Morulaa Healthtech, we assist medical device manufacturers in maintaining full compliance with MDR 2017/745 through comprehensive regulatory services. Our support includes:
- Detailed gap assessments and standard mapping
- Technical documentation updates in line with Annex II and Annex III
- Alignment of revised test protocols and performance data
- Coordination with Notified Bodies for regulatory submissions
With a team of experienced regulatory professionals, Morulaa ensures your product documentation stays current, compliant, and audit-ready. For dedicated support in transitioning to EN 13795, EN 14683, or EN 14180:2025, our team is ready to guide you every step of the way.