Sterile gloves, sterile devices and patient transport equipment: what changed in 2025
In 2025, the European Commission introduced a new set of harmonised standards under the MDR (EU) 2017/745 and IVDR (EU) 2017/746 frameworks. These updates directly affect MDR technical documentation required for compliance and market access.
If you manufacture single-use medical gloves, sterile-labelled medical devices, or patient transport equipment, you may need to update your technical documentation and conformity assessment procedures.
New harmonised standards published in 2025
Implementing Decision (EU) 2025/681 harmonised the following standards under MDR:
- EN 455-1:2020+A2:2024 – Medical gloves for single use. Requirements and testing for freedom of holes
- EN 455-2:2024 – Medical gloves for single use – Part 2: Requirements and testing for physical properties
- EN 556-1:2024 – Sterilization of medical devices. Requirements for medical devices to be designated “STERILE”. Requirements for terminally sterilized medical devices
- EN 556-2:2024 – Sterilization of medical devices – Requirements for medical devices to be designated “STERILE” – Part 2: Requirements for aseptically processed medical devices
- EN 1865-2:2024 – Patient handling equipment used in ambulances – Part 2: Power assisted stretcher
- EN 1865-6:2024 – Patient handling equipment used in ambulances – Part 6: Powered chairs
For IVDs, Implementing Decision (EU) 2025/679 includes:
- EN 556-1:2024 – Sterilization of medical devices. Requirements for medical devices to be designated “STERILE”. Requirements for terminally sterilized medical devices
- EN 556-2:2024 – Sterilization of medical devices – Requirements for medical devices to be designated “STERILE” – Part 2: Requirements for aseptically processed medical devices
Why you must update your MDR technical documentation
These harmonised standards 2025 aim to strengthen medical device conformity across the EU market. However, manufacturers must take action to maintain MDR compliance.
You should revise your MDR technical documentation to:
- Reference the correct versions of the newly harmonised standards
- Verify that performance and safety requirements are still fulfilled
- Update risk assessments and clinical evaluations accordingly
Compliance and MDR documentation updates for manufacturers
To comply with MDR and IVDR, you should:
-
Review your existing technical documentation for all affected product categories
- Update labelling, instructions for use, and sterilisation validations where needed
- Make sure all test reports rely on the most current harmonised standards
Not sure if your device complies with the 2025 harmonised standards?
We support manufacturers in updating MDR technical documentation and applying MDR and IVDR requirements correctly.
