EU MDR harmonised standards 2026 introduce important changes for medical electrical safety, biological evaluation, labelling and other medical-device sectors. Manufacturers should review applicable clauses and existing evidence before ordering new equipment or repeating tests.
Scope correction:
Commission Implementing Decision (EU) 2026/1231 is a broad MDR harmonised-standard update. Commission Implementing Decision (EU) 2026/1313 is narrower and updates the IVDR harmonised-standard reference for EN ISO 15223-1:2021/A1:2025. Do not describe it as a general overhaul of IVD electrical-safety testing.
EU MDR Harmonised Standards 2026: Executive Summary
The European Commission published two harmonised-standard updates in the Official Journal of the European Union in June 2026. Decision (EU) 2026/1231 amends the MDR list under Regulation (EU) 2017/745, while Decision (EU) 2026/1313 amends the IVDR list under Regulation (EU) 2017/746.
For many KingPo customers, the most relevant addition is EN 60601-1:2006/A13:2024 under the MDR. Manufacturers and laboratories should review existing test plans, fixtures, measurement systems, calibration scope and technical documentation. This does not mean that every medical electrical device must be completely retested or that every new reference requires a new machine.
Broad MDR Update
Decision (EU) 2026/1231
Medical electrical equipment, biological evaluation, symbols, transfusion equipment, ophthalmic optics, implants, washer-disinfectors, prosthetics and sharps protection.
Focused IVDR Update
Decision (EU) 2026/1313
EN ISO 15223-1:2021/A1:2025 concerning symbols used with information supplied by the manufacturer.
What Changed in the EU MDR Harmonised Standards 2026?
Medical electrical safety
EN 60601-1:2006/A13:2024 was added to the MDR harmonised-standards list.
Home light therapy
EN IEC 60601-2-83:2020/A1:2025 was added for applicable home light therapy equipment.
Biological evaluation
EN ISO 10993-1:2025 and several related amendments were added or updated.
Labelling symbols
EN ISO 15223-1:2021/A1:2025 was referenced under both MDR and IVDR.
Additional device sectors
Transfusion sets, washer-disinfectors, ophthalmic products, implants, prosthetics and sharps protection were covered.
Transition timing
The corrigendum corrected the relevant EN ISO 15223-1 transition date under Decision 2026/1231 to 17 June 2031.
What Is an EU Harmonised Standard?
A harmonised European standard is developed by a recognised European standardisation organisation following a request from the European Commission. Once the reference is published in the Official Journal, applying the relevant provisions may provide a presumption of conformity with the MDR or IVDR requirements covered by that standard.
That presumption is limited. It does not replace device-specific regulatory analysis, risk management, verification, clinical or performance evidence, post-market obligations or notified-body review.
- Confirm whether the standard applies to the device.
- Map the covered General Safety and Performance Requirements.
- Document exclusions, deviations and alternative methods.
- Assess whether existing test evidence remains technically valid.
- Coordinate material changes with the responsible notified body.
Key MDR Changes Under Decision (EU) 2026/1231
EN 60601-1:2006/A13:2024
Decision 2026/1231 adds EN 60601-1:2006 together with amendment A13:2024 to the MDR harmonised-standards list. The change is directly relevant to electrically powered medical devices and laboratories performing basic-safety and essential-performance testing.
A complete IEC/EN 60601-1 programme is not performed with one universal tester. Depending on the device, applicable clauses and laboratory test plan, the setup may include:
- Power-input measurement and supply conditioning.
- Protective-earth continuity, leakage current and patient auxiliary current.
- Dielectric strength and insulation evaluation.
- Test probes for accessible-part assessment.
- Temperature rise and abnormal-operation testing.
- Mechanical strength, stability and support-system loading.
- Ingress-protection evaluation.
- Defibrillation protection and energy-reduction testing.
- Working-voltage, creepage, clearance and fire-hazard assessments.
EN IEC 60601-2-83:2020/A1:2025
This particular standard addresses the basic safety and essential performance of home light therapy equipment. Applicable manufacturers should review changes to test conditions, essential-performance definitions, optical-radiation controls, thermal evaluations, marking, instructions and abnormal-operation testing.
This is a device-specific update. It should not be presented as evidence that all IEC 60601 particular standards were changed by Decision 2026/1231.
Biological Evaluation Standards
The decision adds or amends references including EN ISO 10993-1:2025, EN ISO 10993-5:2009/A11:2025, EN ISO 10993-12:2021/A1:2025, EN ISO 10993-17:2023/A1:2025 and EN ISO 10993-23:2021/A1:2025.
The correct response is a documented gap assessment, not automatic repetition of every historical biological test. Review materials, manufacturing processes, type and duration of body contact, chemical characterisation, sample preparation, extraction conditions, toxicological methodology and the scientific validity of existing evidence.
EN ISO 15223-1 Labelling Symbols
Both decisions reference EN ISO 15223-1:2021/A1:2025. The amendment introduces a defined term for the authorised representative and modifies the EC REP symbol so that it is not country- or region-specific.
Potentially affected controls include labels, packaging artwork, instructions for use, electronic labelling, authorised-representative information, translation management, distributor inventory and artwork change control.
Correct date:
The corrigendum published on 22 June 2026 changes the applicable date in Decision 2026/1231 from 15 June 2031 to 17 June 2031.
Other Standards Added
| Area | References | Likely Review Focus |
|---|---|---|
| Transfusion equipment | EN ISO 1135-4:2025; EN ISO 1135-5:2025 | Performance requirements, pressure-infusion use and test setup. |
| Ophthalmic optics | EN ISO 12870:2025; EN ISO 14889:2025 | Frame and lens requirements, methods and acceptance criteria. |
| Mammary implants | EN ISO 14607:2025 | Device-specific requirements and verification evidence. |
| Washer-disinfectors | EN ISO 15883-1, -2, -3 and -7:2025 | Thermal/chemical disinfection, process performance and validation. |
| Prosthetics | EN ISO 22675:2025 | Mechanical testing of ankle-foot devices and foot units. |
| Sharps protection | EN ISO 23908:2025 | Protection mechanisms and test methods for single-use sharps. |
What Manufacturers and Laboratories Should Do Now
Build an applicable-standards matrix
Record previous and new editions, affected device models, covered GSPRs, existing reports, identified gaps, responsible owner and completion date.
Perform a clause-level gap assessment
Compare methods, acceptance criteria, conditioning, sample preparation, loads, fixtures, uncertainty, sample quantities, marking and documentation requirements.
Review laboratory equipment
Confirm range, accuracy, resolution, fixture geometry, repeatability, calibration status, software, safety protections and data-export capability.
Coordinate with the notified body
Discuss material effects on active assessments, surveillance audits, certificate renewals, significant changes, biological evaluations and labelling transitions.
Control equipment procurement
Provide the supplier with the standard edition, clause, device drawings, operating ranges, test sequence, calibration expectation and required report format.
How KingPo Supports Medical Device Test Readiness
KingPo Equipment Mapping Table
Use this table to separate standards review work from equipment-driven testing needs. Some MDR updates require laboratory equipment review, while others mainly require document control, labelling review or a biological-evaluation gap assessment.
| MDR Update Area | Testing Concern | KingPo Related Equipment |
|---|---|---|
| EN 60601-1:2006/A13:2024 | Leakage current, dielectric strength, mechanical safety | IEC 60601-1 test equipment |
| EN IEC 60601-2-83 | Home light therapy safety | Electrical safety + thermal + optical test support |
| EN ISO 10993 updates | Biological evaluation planning | Not equipment-driven; document gap assessment |
| EN ISO 15223-1/A1 | Labelling symbols | Not a test equipment issue |
| ISO 80369 connector verification | Small-bore connector testing | ISO 80369 Luer gauges and connector test equipment |
IEC 60601-1 Equipment Planning
Clause-based selection of test instruments, probes, networks, mechanical fixtures, dielectric-strength systems, leakage-current equipment and customised configurations.
IEC 60601-2-2 Electrosurgical Testing
Equipment mapping for electrosurgical-unit safety and performance, including the KP-8850 high-frequency ESU analyser and neutral-electrode test solutions.
View the IEC 60601-2-2 Equipment Guide →
Review the KP-8850 ESU Analyzer →
ECG and Defibrillation Testing
Systems for disposable ECG electrode performance evaluation and defibrillation-effect or energy testing, selected according to the applicable standard and clause.
ECG Electrode Performance Tester →
Defibrillation Effect and Energy Tester →
ISO 80369 Connector Verification
Luer gauges, Annex C reference connectors and ISO 80369-20-related test support for medical small-bore connector verification.
Medical Test Equipment Procurement Checklist
- Which exact standard edition and amendments apply?
- Is the reference harmonised under MDR or IVDR?
- Which clauses apply to the device?
- What ranges, accuracy and uncertainty are required?
- Are special reference devices or fixtures required?
- Is ISO/IEC 17025-accredited calibration required?
- Must the system export data or connect to a LIMS?
- Is automation or unattended testing required?
- Is the equipment for R&D screening or formal type testing?
- Has the complete setup been reviewed by the responsible laboratory?
Conclusion
The EU MDR harmonised standards 2026 update under Decision 2026/1231 is broad and includes EN 60601-1:2006/A13:2024, EN IEC 60601-2-83:2020/A1:2025, multiple EN ISO 10993 references, EN ISO 15223-1:2021/A1:2025 and standards for several additional medical-device sectors.
Decision 2026/1313 is narrower and updates the IVDR harmonised reference for EN ISO 15223-1:2021/A1:2025. Manufacturers should perform a clause-level review of standards, verification evidence, labelling, risk management and laboratory capability before deciding whether new testing or equipment is required.
Frequently Asked Questions About EU MDR Harmonised Standards 2026
Official Sources
Need a Clause-Based Proposal for EU MDR Harmonised Standards 2026?
Send KingPo the applicable standard, clause number, device type, sample drawing, required range, automation needs and calibration expectations. Our engineering team can review the complete test configuration before quotation.
Compliance notice: This article is a technical overview and does not replace the official MDR, IVDR, harmonised standards, notified-body instructions or legal advice. Always use the official standard edition and the requirements applicable to the specific device and conformity-assessment project.
