Recently, twelve standards were added to the list of harmonized standards under the EU MDR (Regulation (EU) 2017/745). The list of standards, published in Commission Implementing Decision (EU) 2026/193, can be found here.
This includes the following additions:
- EN ISO 10993-4:2017/A1:2025 Biological evaluation of medical devices – Part 4: Selection of tests for interactions with blood
- EN ISO 14155:2020/A11:2024 Clinical evaluations of medical devices for human subjects – Good clinical practice
- EN ISO 17665:2024 Sterilization of healthcare products with moist heat
- Three standards describe requirements for non-active surgical implants (EN ISO 14630:2020, EN ISO 21535:2024, and EN ISO 21536:2024)
- Four standards describe the biocompatibility evaluation of breathing gas pathways (EN ISO 18562-1:2024 through EN ISO 18562-4:2024)
- Standards for neurosurgical implants (EN ISO 7197:2024) and Small-bore connectors for liquids and gases in healthcare applications (EN ISO 80369-2:2024)
Additionally, six standards were added to the list of harmonized standards under the EU IVDR (Regulation (EU) 2017/746). The list of standards, published in Commission Implementing Decision (EU) 2026/197, can be found here.
This includes the following additions:
- Five standards (EN ISO 18113-1:2024 through EN ISO 18113-5:2024) include requirements for information supplied by the manufacturer of in vitro diagnostic devices.
- EN ISO 17665:2024 Sterilization of healthcare products with moist heat.
MDSS supports manufacturers in assessing the impact of newly harmonized standards, performing gap analyses, and implementing necessary updates efficiently.
👉 Contact us to discuss how these updates may affect your devices and how we can support your compliance strategy.
