EU Harmonised Standards Update 2026 Under MDR (EU) 2026/193

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

The revised standard updates safety, performance, and material requirements for neurosurgical implants.

Biological Evaluation of Medical Devices

This amendment strengthens requirements related to blood–device interactions and biological risk evaluation.

Clinical Investigation of Medical Devices

The update reinforces ethical safeguards, data quality, and MDR-aligned clinical investigation practices.

Non-Active Surgical Implants

These revisions modernise mechanical performance, long-term safety, and risk management expectations.

Sterilisation of Health Care Products

The updated standard reflects advances in sterilisation validation, process control, and lifecycle management.

Biocompatibility of Breathing Gas Pathways

These updates strengthen chemical and particulate safety requirements for respiratory and anaesthesia devices.

Small-Bore Connectors for Liquids and Gases

^{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 Continued reliance on superseded standards may trigger questions during: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

• EU Medical Device Classification & Regulation (MDR/IVDR)

External Reference

• Official Journal of the European Union – Implementing Decision (EU) 2026/193 (PDF)

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