On 30 January 2026, the European Commission published Commission Implementing Decision (EU) 2026/193, introducing an important MDR update by amending Implementing Decision (EU) 2021/1182. The decision adds new references to harmonised standards under the Medical Device Regulation (EU) 2017/745 (MDR).
Loading...
Update on EU MDR: New Harmonised Standards Published under Implementing Decision (EU) 2026/193
Loading...
For manufacturers of medical devices, this update is highly relevant. The publication of harmonised standards in the Official Journal of the European Union (OJEU) confers presumption of conformity with the corresponding MDR requirements covered by those standards. In an evolving regulatory environment, Commission Implementing Decision (EU) 2026/193 offers both clarity and strategic direction for compliance planning.
Below, we highlight the most crucial changes and their practical implications.
Why This MDR Update on Harmonised Standards Matters
Under Article 8(1) of the MDR, devices that comply with relevant harmonised standards, once their references are published in the OJEU, are presumed to be in conformity with the corresponding regulatory requirements .
For manufacturers, this means:
- Clear technical benchmarks aligned with MDR expectations
- Greater legal certainty
- More structured technical documentation
- A more predictable conformity assessment process
With increased scrutiny and limited notified body capacity, aligning with harmonised standards introduced through Commission Implementing Decision (EU) 2026/193 is not only a regulatory obligation but also a strategic advantage.
Key Standards Newly Added or Updated
The amendment introduces revised versions of several critical standards and amendments. Here below you will find the listed in the annex of the implementing decision:
No | Reference of the standard |
| 37. | EN ISO 7197:2024 Neurosurgical implants – Sterile, single-use hydrocephalus shunts (ISO 7197:2024) |
| 38. | EN ISO 10993-4:2017 Biological evaluation of medical devices – Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017) EN ISO 10993-4:2017/A1:2025 |
| 39. | EN ISO 14155:2020 Clinical investigation of medical devices for human subjects – Good clinical practice (ISO 14155:2020) EN ISO 14155:2020/A11:2024 |
| 40. | EN ISO 14630:2024 Non-active surgical implants – General requirements (ISO 14630:2024) |
| 41. | EN ISO 17665:2024 Sterilization of health care products – Moist heat – Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665:2024) |
| 42. | EN ISO 18562-1:2024 Biocompatibility evaluation of breathing gas pathways in healthcare applications – Part 1: Evaluation and testing within a risk management process (ISO 18562-1:2024) |
| 43. | EN ISO 18562-2:2024 Biocompatibility evaluation of breathing gas pathways in healthcare applications – Part 2: Tests for emissions of particulate matter (ISO 18562-2:2024) |
| 44. | EN ISO 18562-3:2024 Biocompatibility evaluation of breathing gas pathways in healthcare applications – Part 3: Tests for emissions of volatile organic substances (ISO 18562-3:2024) |
| 45. | EN ISO 18562-4:2024 Biocompatibility evaluation of breathing gas pathways in healthcare applications – Part 4: Tests for leachables in condensate (ISO 18562-4:2024) |
| 46. | EN ISO 21535:2024 Non-active surgical implants – Joint replacement implants – Specific requirements for hip-joint replacement implants (ISO 21535:2023) |
| 47. | EN ISO 21536:2024 Non-active surgical implants – Joint replacement implants – Specific requirements for knee-joint replacement implants (ISO 21536:2023) |
| 48. | EN ISO 80369-2:2024 Small-bore connectors for liquids and gases in healthcare applications – Part 2: Connectors for respiratory applications (ISO 80369-2:2024, Corrected version 2025-06) |
Strategic Implications for Manufacturers
Beyond the technical updates, this decision signals continued regulatory alignment with state-of-the-art standards. The Commission confirms that these standards support the requirements of Regulation (EU) 2017/745 .
For manufacturers, three strategic considerations arise:
1. Timing Is Critical
Once a new harmonised reference is published, reliance on older versions may no longer provide presumption of conformity in the long term. Early alignment reduces regulatory risk.
2. Technical Documentation Must Be Dynamic
MDR compliance is not static. Gap analyses against updated harmonised standards should become a structured part of regulatory surveillance.
3. Strong Risk Management Integration
Many of the updated standards reinforce risk-based thinking. Ensuring full alignment between risk management (ISO 14971), clinical evaluation, and performance validation remains essential.
From Compliance to Confidence
Regulatory updates can feel like an additional burden in an already complex MDR landscape. Yet, harmonised standards also provide clarity. They translate essential requirements into concrete technical specifications and create a shared understanding between manufacturers and notified bodies.
Organizations that proactively review and align their systems not only strengthen regulatory confidence—they enhance internal robustness, patient safety, and long-term market access.
What Should You Do Now?
- Identify which of the newly harmonised standards apply to your device portfolio
- Conduct a structured gap analysis
- Update technical documentation and quality management processes accordingly
- Engage early with your notified body if substantial changes are expected
In a high-stakes regulatory environment, structured alignment with harmonised standards is more than a formal requirement, it is a driver of resilience and credibility.
Act Now: Turn the MDR Update into a Strategic Advantage
Now is the time to move from basic conformity to regulatory confidence.
Author
DQS Global
"In everything we do, we set the highest standards for quality and competence in every project. This makes our actions the benchmark for our industry, but also our own mission statement, which we renew every day"
Loading...
