EU Harmonised Standards Update 2026 Under MDR (EU) 2026/193
Commission Implementing Decision (EU) 2026/193 updates EU harmonised standards supporting the Medical Device Regulation (EU) 2017/745. Revised ISO standards now cover neurosurgical implants, biological and clinical evaluation, sterilisation, non-active surgical implants, breathing gas pathways, and small-bore connectors. Manufacturers should assess gaps, update technical documentation, and align conformity strategies to maintain MDR compliance.
The European Commission Implementing Decision (EU) 2026/193, adopted on 28 January 2026, updates the list of EU harmonised standards for medical devices supporting Regulation (EU) 2017/745 (MDR). The decision amends Implementing Decision (EU) 2021/1182 and incorporates revised standards developed by CEN and Cenelec to reflect the latest technical and scientific progress.
These changes are directly relevant for manufacturers relying on harmonised standards to demonstrate presumption of conformity with MDR General Safety and Performance Requirements (GSPRs).
Key Updates in Commission Implementing Decision (EU) 2026/193
Neurosurgical Implants
| Area | Replaced Standard | New / Revised Standard |
|---|---|---|
| Neurosurgical implants | EN ISO 7197:2009 | EN ISO 7197:2024 |
The revised standard updates safety, performance, and material requirements for neurosurgical implants.
Biological Evaluation of Medical Devices
| Area | Replaced Standard | New / Revised Standard |
|---|---|---|
| Biological evaluation (blood interaction) | EN ISO 10993-4:2017 | EN ISO 10993-4:2017/A1:2025 |
This amendment strengthens requirements related to blood–device interactions and biological risk evaluation.
Clinical Investigation of Medical Devices
| Area | Replaced Standard | New / Revised Standard |
|---|---|---|
| Clinical investigation involving human subjects | EN ISO 14155:2020 | EN ISO 14155:2020/A11:2024 |
The update reinforces ethical safeguards, data quality, and MDR-aligned clinical investigation practices.
Non-Active Surgical Implants
| Area | Replaced Standards | New / Revised Standards |
|---|---|---|
| General requirements for non-active surgical implants | EN ISO 14630:2012 | ISO 14630:2024 |
| Total joint replacement implants | EN ISO 21535:2009 | EN ISO 21535:2024 |
| Partial and hemi-joint replacement implants | EN ISO 21536:2009 | EN ISO 21536:2024 |
These revisions modernise mechanical performance, long-term safety, and risk management expectations.
Sterilisation of Health Care Products
| Area | Replaced Standard | New / Revised Standard |
|---|---|---|
| Moist heat sterilisation | EN ISO 17665-1:2006 | EN ISO 17665:2024 |
The updated standard reflects advances in sterilisation validation, process control, and lifecycle management.
Biocompatibility of Breathing Gas Pathways
| Area | Replaced Standards | New / Revised Standards |
|---|---|---|
| Part 1 – Evaluation and testing | EN ISO 18562-1:2020 | EN ISO 18562-1:2024 |
| Part 2 – Emissions of particulate matter | EN ISO 18562-2:2020 | EN ISO 18562-2:2024 |
| Part 3 – Emissions of volatile organic compounds | EN ISO 18562-3:2020 | EN ISO 18562-3:2024 |
| Part 4 – Leachables in condensate | EN ISO 18562-4:2020 | EN ISO 18562-4:2024 |
These updates strengthen chemical and particulate safety requirements for respiratory and anaesthesia devices.
Small-Bore Connectors for Liquids and Gases
| Area | Previous Harmonised Standard | New Drafted Standard |
|---|---|---|
| Small-bore connectors for respiratory applications | Not previously harmonised | EN ISO 80369-2:2024 |
Note: The reference to EN ISO 80369-2:2024 has not yet been published in the Official Journal of the European Union.
These new standard addresses misconnection risks and supports MDR safety requirements using updated technical knowledge.
Impact on MDR Compliance for Manufacturers
The revised harmonised standards affect manufacturers across multiple device categories. Continued reliance on superseded standards may trigger questions during:
Notified Body conformity assessments
Technical documentation reviews
Clinical and biological evaluation updates
Post-market surveillance and vigilance activities
While harmonised standards remain voluntary, alignment with the latest versions is strongly recommended.
Recommended Compliance Actions
Manufacturers should:
Conduct gap assessments against revised harmonised standards
Update technical documentation and risk management files
Review clinical evaluation and biological evaluation reports
Reassess sterilisation validation and respiratory safety testing
Engage early with Notified Bodies on transition planning
Early adoption helps minimise regulatory risk and supports smoother MDR compliance.
Internal Reference
External Reference
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