EU MDR Harmonised Standards: Complete 2026 List, GSPR Mapping, and Presumption of Conformity Guide

The Harmonisation Gap Is the Biggest Compliance Challenge You Haven't Addressed

As of January 2026, only 48 of the 277 standards requested for harmonisation under the EU Medical Device Regulation have been published in the Official Journal of the European Union. That is 17%. The remaining 83% — covering everything from software lifecycle processes to biocompatibility testing to sterilization validation — exist in a regulatory grey zone where manufacturers must demonstrate compliance with the General Safety and Performance Requirements (GSPR) without the benefit of a presumption of conformity.

The situation is improving. The European Commission published Implementing Decision (EU) 2026/193 on January 30, 2026, adding twelve new standards to the harmonised list. Three more were added in April 2026. But the pace of harmonisation remains far behind the original standardisation request timeline, and the gap between what Notified Bodies expect and what has been officially harmonised continues to create compliance uncertainty.

This guide covers everything manufacturers need to know about harmonised standards under the MDR: the legal framework, how presumption of conformity works, the complete 2026 list, GSPR mapping methodology, the standardisation request process, how to handle non-harmonised standards, and practical strategies for navigating the gap.

What Are Harmonised Standards?

Harmonised standards are European standards developed by CEN (European Committee for Standardization), CENELEC (European Committee for Electrotechnical Standardization), and ETSI (European Telecommunications Standards Institute) on the basis of a standardisation request (mandate) issued by the European Commission. Once their references are published in the Official Journal of the European Union (OJEU), voluntary use of these standards confers presumption of conformity with the MDR requirements they aim to cover.

The key principles:

1. Use is voluntary: Manufacturers are never legally required to use harmonised standards. You can demonstrate GSPR compliance through other means.
2. Presumption of conformity is automatic: If you apply a harmonised standard within its scope and as specified, you are presumed to comply with the GSPR clauses it covers.
3. Partial application is possible: You can use some harmonised standards and demonstrate compliance with other GSPR requirements through alternative evidence.
4. Standards have Annex Z: Each harmonised standard contains an informative annex (typically Annex Z) that maps standard clauses to specific GSPR requirements, showing exactly which GSPR elements are covered.

Legal Basis: Article 8 of the MDR

Article 8 establishes the relationship between harmonised standards and the MDR:

Paragraph 1 — Presumption of Conformity

Devices which are in conformity with the relevant harmonised standards, or the relevant parts of those standards, the references of which have been published in the OJEU, shall be presumed to be in conformity with the requirements of the MDR covered by those standards or parts thereof.

Paragraph 2 — Partial Coverage

The Commission may publish references to harmonised standards that cover only some of the requirements of the MDR. In this case, manufacturers must demonstrate compliance with the non-covered requirements through other means.

Paragraph 3 — Withdrawal

The Commission may request that a standardisation organisation amend, maintain, or withdraw a harmonised standard if it no longer meets the requirements for presumption of conformity.

The Standardisation Request: M/575

The European Commission issued standardisation request M/575 to CEN and CENELEC on April 14, 2021, requesting the development and harmonisation of over 250 standards in support of the MDR and IVDR. The request has been amended twice:

• M/575 Amd 1 (January 31, 2023): Additional standards added
• M/575 Amd 2 (May 27, 2024): Further additions and modifications

A consolidated version of M/575 is available on the European Commission's eNorm Platform. The deadline for completion of most standards was originally October 2024, later extended to May 2028.

The Numbers (January 2026)

The Complete 2026 List of Harmonised Standards Under the MDR

The harmonised standards are published across multiple implementing decisions. The most recent updates include:

Implementing Decision (EU) 2026/193 — Published January 30, 2026

This decision added twelve new standards:

April 2026 Additions

Three additional standards were harmonised in April 2026:

Previously Harmonised Standards (Key References)

Critical Standards NOT Yet Harmonised (as of April 2026)

These widely-used standards have NOT been published in the OJEU and do NOT carry presumption of conformity under the MDR:

GSPR Mapping: How to Build Your Compliance Matrix

Every manufacturer must create a compliance matrix mapping each GSPR clause to the evidence demonstrating compliance. Here is how to structure it when using harmonised standards:

Step 1: List All Applicable GSPR Clauses

MDR Annex I contains 23 GSPR clauses organized in three chapters:

• Chapter I: General requirements (GSPR 1-10) — Risk management, benefit-risk, clinical evidence, pharmaceutical substances, biological safety
• Chapter II: Design and manufacture (GSPR 11-14) — Chemical/physical/biological properties, infection control, environmental properties
• Chapter III: Information supplied with the device (GSPR 15-23) — Labeling, IFU, patient identification

Step 2: Map Standards to GSPR Clauses

For each GSPR clause, determine which harmonised standard(s) provide presumption of conformity:

Step 3: Document Compliance or Justification

For each GSPR clause:

• If a harmonised standard covers it: Document that you have applied the standard within its scope. The presumption of conformity applies automatically.
• If no harmonised standard covers it: Document your alternative evidence — test reports, literature, risk analysis, clinical data, or other technical justification.
• If a standard exists but is not harmonised: You may still use it as evidence of best practice, but you must independently demonstrate that it achieves the required level of safety. The presumption of conformity does not apply.

The "State of the Art" Problem

One of the most challenging aspects of the harmonisation gap is the concept of "state of the art" (SOTA). The MDR requires devices to conform to the state of the art, and harmonised standards are considered to represent the state of the art at the time of their publication. But when a standard is not harmonised:

1. Notified Bodies may still expect you to follow the latest version of a non-harmonised standard as representing the state of the art
2. You cannot claim presumption of conformity, even if you fully comply with the standard
3. You must provide additional evidence that your approach meets the GSPR requirements
4. The Notified Body has more discretion in assessing your compliance

This creates an asymmetric burden: manufacturers who follow non-harmonised standards must invest more documentation effort to prove what harmonised standard users get automatically.

Practical Compliance Strategies

Strategy 1: Prioritise Harmonised Standards

Where a harmonised standard exists for your device type, use it. This is the path of least resistance. Notified Bodies generally expect manufacturers to apply relevant harmonised standards, and the presumption of conformity significantly reduces review time and back-and-forth queries.

Strategy 2: Build Robust Alternative Evidence for Non-Harmonised GSPR Clauses

For GSPR clauses where no harmonised standard exists, develop comprehensive evidence packages:

• Internal test protocols and reports
• Literature reviews demonstrating safety and performance
• Risk analyses specifically addressing the GSPR requirement
• Comparison with predicate devices using the same technology

Strategy 3: Monitor OJEU Publications

The harmonisation list is updated multiple times per year. Implement a regulatory intelligence process to track new publications:

• January 2026: Implementing Decision (EU) 2026/193 (12 new standards)
• April 2026: Three additional standards (sterilizers, steam boilers, hearing aids)
• Next expected update: Mid-2026

Strategy 4: Use MDCG Guidance Documents

When standards are not harmonised, MDCG guidance documents provide the next best source of compliance direction:

• MDCG 2021-5 rev.1: Guidance on standardisation for medical devices
• MDCG 2020-1: Clinical evaluation guidance
• MDCG 2020-5: Clinical evaluation of equivalence

Strategy 5: Track Standard Versions

When a harmonised standard references a specific version (e.g., EN ISO 14971:2019/A11:2021), you must use that version to claim presumption of conformity. Using a newer version that has not yet been harmonised means you lose the presumption. Maintain a register of:

• Which version is harmonised
• Which version you are using
• Whether you are claiming presumption of conformity or alternative compliance

The IEC/CEN Court Case: A 2026 Development

A significant development in 2026 is the ongoing ISO/IEC court case that could affect the future of standardisation in Europe. The case relates to copyright restrictions on referencing ISO/IEC standards in European harmonisation processes. If resolved in a way that restricts CEN/CENELEC's ability to adopt ISO/IEC standards, it could further slow the harmonisation pace under the MDR. The MDCG Standards Working Group is actively monitoring this situation.

Harmonised Standards and the 2025 Simplification Proposal

The December 2025 MDR/IVDR simplification proposal (COM(2025)1023) does not directly change the harmonised standards framework. However, it does propose:

• Broader acceptance of non-clinical data for demonstrating safety and performance
• Greater flexibility in clinical evidence approaches
• Potential for faster adoption of standards through streamlined processes

These proposals are under legislative review and have not been adopted as of April 2026.

Frequently Asked Questions

What does "presumption of conformity" actually mean?

It means that if you correctly apply a harmonised standard within its specified scope, Notified Bodies and Competent Authorities must accept that you comply with the GSPR clauses covered by that standard. They cannot require additional evidence for those specific requirements. However, the presumption only covers the GSPR elements explicitly mapped in the standard's Annex Z — it does not extend beyond the standard's scope.

Are harmonised standards mandatory?

No. The use of harmonised standards is entirely voluntary. You can demonstrate GSPR compliance through any technically valid means. However, using harmonised standards is the path of least resistance because it grants automatic presumption of conformity, which significantly simplifies the conformity assessment process.

What percentage of MDR standards have been harmonised?

As of January 2026, approximately 17% of the 277 standards requested for harmonisation under the MDR have been published in the OJEU (48 standards). For the IVDR, approximately 31% of 49 requested standards have been harmonised (~15 standards). The European Commission acknowledges this gap and continues to publish new harmonisation decisions.

What happens if a standard I use is not harmonised?

You can still use it as evidence of good practice, but you do not get presumption of conformity. You must independently demonstrate that your approach meets the applicable GSPR requirements through additional test reports, risk analyses, literature reviews, or other technical evidence. Notified Bodies will scrutinize this evidence more closely than they would a harmonised standard application.

How often is the harmonised standards list updated?

The list is updated through Commission Implementing Decisions published in the OJEU. In 2025-2026, updates occurred approximately every 3-4 months: October 2025 (Decision (EU) 2025/2078), January 2026 (Decision (EU) 2026/193), and April 2026. Manufacturers should monitor the European Commission's health portal for new publications.

Can I use a newer version of a standard than what has been harmonised?

Yes, but you lose the presumption of conformity for the differences between the harmonised version and the newer version. You must document and justify compliance with the newer version's additional or modified requirements through alternative evidence. Many manufacturers choose to apply the harmonised version for the presumption of conformity while also considering the newer version's requirements.

How do I find out which GSPR clauses a harmonised standard covers?

Each harmonised standard contains an informative annex (typically Annex Z in EN standards) that maps the standard's clauses to specific GSPR requirements. This annex shows exactly which GSPR elements are covered, giving you a clear scope of the presumption of conformity.

What is MDCG 2021-5 rev.1?

This is the MDCG guidance document on standardisation for medical devices. It explains the role of harmonised standards in the MDR framework, how presumption of conformity works, how to handle non-harmonised standards, and the concept of state of the art. It is the primary guidance document for manufacturers navigating the standards landscape.

Do I need to reference harmonised standards in my Declaration of Conformity?

Yes. Article 19 and Annex IV of the MDR require the DoC to include references to the harmonised standards that have been applied. If you have applied common specifications instead of or in addition to harmonised standards, these must also be referenced. The DoC must identify the specific standards and their version numbers.

What is the standardisation request M/575?

M/575 is the formal request issued by the European Commission to CEN and CENELEC on April 14, 2021, asking them to develop and adopt over 250 standards in support of the MDR and IVDR. The request has been amended twice (January 2023, May 2024) to expand the scope. The consolidated version is available on the eNorm Platform. The deadline for most standards is May 2028.