---
title: The IMDRF and Global Harmonization: How International Frameworks Help Startups
description: The International Medical Device Regulators Forum creates harmonised guidance across jurisdictions. Here is what IMDRF is and how startups can use it strategically.
authors: Tibor Zechmeister, Felix Lenhard
category: FDA & International Market Access
primary_keyword: IMDRF global harmonization
canonical_url: https://zechmeister-solutions.com/en/blog/imdrf-global-harmonization-startups
source: zechmeister-solutions.com
license: All rights reserved. Content may be cited with attribution and a link to the canonical URL.
---

# The IMDRF and Global Harmonization: How International Frameworks Help Startups

*By Tibor Zechmeister (EU MDR Expert, Notified Body Lead Auditor) and Felix Lenhard.*

> **The International Medical Device Regulators Forum (IMDRF) is a voluntary group of medical device regulators from around the world that develops harmonised guidance on topics such as software as a medical device, unique device identification, quality management, and auditing. IMDRF does not make law. It produces consensus documents that national and regional regulators can adopt, adapt, or reference in their own frameworks. For startups planning multi-market access, IMDRF is useful at three levels: it explains why different regulators use similar concepts, it reduces the surprise factor when moving between jurisdictions, and it underpins schemes like MDSAP that turn harmonisation into practical audit efficiency. IMDRF is not a shortcut to market access and not a replacement for the EU MDR or any other national regulation.**

**By Tibor Zechmeister and Felix Lenhard. Last updated 10 April 2026.**

---

## TL;DR

- IMDRF is a voluntary forum of medical device regulators that develops harmonised guidance; it is not a regulator and does not issue binding rules of its own.
- IMDRF continues the work of the earlier Global Harmonization Task Force (GHTF) and has produced consensus documents on topics including software as a medical device, quality management, auditing, unique device identification, and adverse event terminology.
- IMDRF guidance becomes practically binding only when a national or regional regulator adopts it. The EU MDR, the FDA framework, Health Canada, the TGA, Japan's PMDA, and others all draw on IMDRF concepts to different degrees.
- MDSAP — the Medical Device Single Audit Program — is the most visible operational outcome of IMDRF-style harmonisation, allowing a single QMS audit to satisfy the inspection needs of five participating authorities.
- For startups, IMDRF is a strategic lens, not a submission pathway. It helps you plan multi-market work with a shared vocabulary and fewer surprises, but every market still requires its own national or regional submission.

---

## Why a German founder asked about IMDRF in a fundraising meeting

A few years ago, a founder we were helping prepare for a Series A pitch got an unexpected question from an investor who had spent a decade in global MedTech. The deck had the usual market map — EU first, US second, Asia-Pacific later. The investor asked, "Which parts of your regulatory strategy rely on harmonised frameworks, and which parts are genuinely separate work in each market?"

The founder froze. The rehearsed answer was about CE marking and a later FDA pathway. There was nothing in the deck about the underlying harmonisation layer that made a multi-market plan credible in the first place. The investor was not looking for a buzzword. They were checking whether the company understood that the cost of entering three markets is not three times the cost of entering one — it is closer to one-point-five times, but only if the plan is built on top of the harmonised parts and does not duplicate them by accident.

That meeting is the reason this post exists. IMDRF is not a topic most first-time founders encounter until an investor, a consultant, or a Notified Body auditor mentions it offhand. By then the regulatory plan has usually been built market by market, in isolation, and the harmonisation layer is invisible. This post puts the layer on the table early.

## What IMDRF actually is

The International Medical Device Regulators Forum is a voluntary group of medical device regulators from around the world that develops harmonised guidance on topics of shared regulatory interest. It was established in 2011 as a successor to the earlier Global Harmonization Task Force (GHTF, active from 1992 to 2012), and it continues the long-running effort to reduce unnecessary divergence between national medical device frameworks.

IMDRF is a forum, not a regulator. It does not issue laws. It does not clear or approve devices. It does not inspect manufacturers or designate conformity assessment bodies. What it does is convene the regulators who do all of those things, inside their own jurisdictions, and produce consensus documents that describe shared approaches to common problems. The forum operates through working groups that tackle specific topics, draft guidance documents over a period of months or years, open them for public consultation, and eventually publish final versions on the IMDRF public site.

The forum's output is intentionally abstracted from any single legal system. An IMDRF document on, for example, software as a medical device will describe concepts and categories that can map into the EU MDR, the US FDA framework, Health Canada's rules, the TGA's framework, Japan's PMDA system, and others — without being the native law of any of them. When a regulator decides to adopt or reference IMDRF content in its own framework, the guidance becomes practically relevant inside that jurisdiction. Until then, it is a shared reference point.

For founders, the mental model is straightforward. IMDRF sits one level above individual regulators. The regulators sit one level above manufacturers. Nothing skips the middle level. You cannot submit to IMDRF. You submit to a national or regional regulator, and that regulator decides — sometimes explicitly, sometimes implicitly — how much of its own approach comes from IMDRF work.

## The member authorities

IMDRF is composed of management committee members drawn from regulatory authorities in several jurisdictions around the world. The exact composition evolves over time as new members join and working group rosters change. The practical point for founders is that the major medical device regulators that most EU startups encounter in a global expansion plan — including the European Commission (representing the EU MDR framework), the US FDA, Health Canada, the Australian TGA, Japan's MHLW/PMDA, Brazil's ANVISA, and others — are present in the forum at different levels of participation.

The European Commission's involvement in IMDRF is the reason the EU MDR is not a purely European invention in its conceptual underpinnings. The MDR's approach to software qualification and classification, its post-market surveillance structure, its vigilance terminology, and its unique device identification system all draw on concepts that were discussed and refined at the IMDRF level (and at the GHTF level before that) over many years. Tibor's practical observation, from Notified Body work, is that auditors who have read both the MDR and the corresponding IMDRF documents find it easier to interpret ambiguous MDR provisions because the IMDRF context explains the intent.

What IMDRF membership does not do is give any jurisdiction the right to bypass another jurisdiction's rules. An FDA clearance does not become a CE certificate because both regulators sit at the same IMDRF table. Market access remains national or regional. The harmonisation layer is conceptual and methodological — not legal.

## The kinds of guidance IMDRF produces

IMDRF's working groups produce documents across a number of recurring topic areas. Without citing specific document numbers (these evolve as revisions are published, and citing them incorrectly is exactly the kind of credibility mistake this blog avoids), the topic areas include:

- **Software as a medical device (SaMD).** IMDRF work on defining what SaMD is, how to categorise its risk, and how to apply quality management to its lifecycle has been particularly influential. The EU MDR's approach to software classification under Annex VIII Rule 11, interpreted alongside MDCG 2019-11, reflects concepts that trace to IMDRF-level discussions.
- **Quality management and auditing.** IMDRF has produced guidance on how auditing organisations should be recognised, how audits of manufacturer QMS should be structured, and how audit findings should be categorised and reported. This work is the conceptual backbone of the Medical Device Single Audit Program (MDSAP), which operationalises IMDRF-style harmonisation into a practical scheme (see below).
- **Unique device identification (UDI).** IMDRF has worked on the harmonised principles behind UDI systems, which now exist in various forms in the EU (Eudamed), the US (FDA's UDI system), and other jurisdictions. The MDR's UDI obligations under Articles 27-28 sit inside a harmonised conceptual framework that IMDRF helped shape.
- **Adverse event terminology and vigilance.** IMDRF has produced terminology work that national vigilance systems use to describe incidents and serious incidents consistently. MDCG 2023-3 Rev.2, the EU's own Q&A on vigilance concepts, operates alongside this harmonised terminology.
- **Regulated product submission structure.** IMDRF has published guidance on how premarket submissions can be structured in a common table of contents that regulators can use as a starting point for their own submission formats.
- **Clinical evaluation and clinical investigation principles.** IMDRF has addressed shared concepts in clinical evidence and the use of real-world data, which national frameworks then adapt to their own legal requirements.

Each of these topic areas is broader than a single document, and the working groups produce revisions over time. For any specific question — "what does IMDRF say about X?" — the right move is to consult the IMDRF public site directly for the current version of the relevant document, rather than relying on secondary descriptions. This post deliberately stays at the topic level for that reason: the areas are stable, the individual documents evolve, and citing them by number in a blog post is a credibility risk we are not going to take.

## How IMDRF influences the EU MDR

The relationship between IMDRF and the EU MDR is indirect but real. The MDR is EU law and is authoritative in its own right under Regulation (EU) 2017/745, with Annexes I through XVII and the full set of articles that govern medical devices in the EU. Nothing in this post should be read as suggesting that IMDRF has legal standing inside the EU framework. It does not.

What IMDRF does is shape the conceptual vocabulary that MDR drafters, MDCG working groups, Notified Bodies, and manufacturers share when they discuss what the MDR means in practice. When the EU writes Rule 11 for software classification, the concept of software as a medical device that the rule is classifying is a concept IMDRF and the earlier GHTF worked on for years. When MDCG 2019-11 Rev.1 clarifies how Rule 11 applies to modular software, it does so in a vocabulary that is internationally familiar. When a startup reads the MDR's post-market surveillance obligations under Articles 83-86 and Annex III, and reads the latest MDCG 2025-10 guidance alongside, the underlying PMS lifecycle concepts are not unique to the EU — they reflect the harmonised understanding that IMDRF continues to refine.

The practical consequence for founders is that preparing for the MDR is not preparing for a purely European document. It is preparing for a European implementation of a largely international conceptual framework. That does not make the MDR easier — the EU-specific legal requirements are real and must be met in full — but it does mean that the investment you make in understanding MDR concepts transfers partially into other markets, because those markets draw on many of the same conceptual roots.

## How to use IMDRF documents in a regulatory strategy

IMDRF documents are not submission templates. They are not checklists you can hand to a Notified Body. They are not a substitute for the MDR itself, for FDA regulations, or for any other binding framework. Used correctly, they play three roles in a startup's regulatory strategy.

**As a shared vocabulary.** When you are discussing your device with a US regulatory specialist, a Notified Body project lead, a Japanese consultant, or a Health Canada specialist, the concepts you all use in conversation — intended purpose, classification, risk, software categorisation, QMS processes, clinical evidence hierarchy — are often IMDRF-shaped concepts. Having read the relevant IMDRF documents in your topic area means you start those conversations inside the shared vocabulary rather than outside it. This is not a certification benefit. It is a communication benefit, and for startups it compounds quickly.

**As an explanation for concept overlap.** When you are building a multi-market QMS and wondering why ISO 13485 feels so similar to the FDA's Quality System Regulation and to Health Canada's expectations, the answer is that the shared framework has been developed and maintained at the international level over decades. When you hit a country-specific difference, knowing that the baseline is shared helps you identify the actual delta rather than treating every market as a fresh problem. The Subtract to Ship approach to multi-market QMS — one honest system with country-specific overlays — is only possible because the baseline is genuinely harmonised.

**As an early-warning system.** IMDRF working groups often work on topics before the national or regional regulators formalise their own positions. Reading IMDRF drafts and finalised documents in your topic area gives you a preview of concepts that may show up in MDR amendments, MDCG guidance, FDA draft guidance, or other national documents in the following years. For founders building in rapidly evolving areas — SaMD, AI/ML devices, real-world evidence — this early-warning view is genuinely useful.

What IMDRF documents are not is a source of specific, binding rules you can cite in a technical file, a CER, or a submission. If you need to justify a decision to a Notified Body, cite the MDR article, the MDCG guidance, or the harmonised standard. IMDRF sits behind those sources, not in place of them.

## The limits of harmonization

Global harmonisation is real, and it is limited. It is important for founders to hold both facts in mind at the same time.

Harmonisation is real at the level of concepts, vocabulary, methodology, and shared audit schemes like MDSAP (see [MDSAP: Using a Single Audit for Multiple Markets](/blog/mdsap-single-audit-multiple-markets) for the operational detail). A device designed with an internationally harmonised vocabulary in mind will travel more easily across jurisdictions than a device designed against only one legal text. A QMS built on ISO 13485 with country-specific overlays will support multiple markets more efficiently than five separate systems built in isolation.

Harmonisation is limited at the level of market access itself. No IMDRF document, no harmonised concept, and no international forum of regulators removes the requirement to submit to each national or regional regulator on its own terms. You still need a CE certificate for the EU (via a Notified Body conformity assessment under the relevant MDR annex). You still need a 510(k), De Novo, or PMA for the US (see the [FDA primer for EU startups](/blog/fda-regulation-medical-devices-primer-eu-startups)). You still need a medical device licence from Health Canada, an ARTG inclusion in Australia, a marketing authorisation in Japan, and an ANVISA registration in Brazil. The harmonisation saves you conceptual rework and, through MDSAP, some audit duplication — it does not save you from the submissions themselves.

Harmonisation is also limited because national regulators preserve the right to diverge. Any given IMDRF concept may be adopted fully by one regulator, adopted with modifications by another, referenced but not formally incorporated by a third, and ignored by a fourth. The fact that IMDRF says something does not mean any specific regulator has done it. The only way to know what your target regulator actually requires is to read the regulator's own rules, which in the EU means reading the MDR and the MDCG guidance directly.

Finally, harmonisation is slower than innovation. IMDRF working groups operate on multi-year cycles. Device technology, especially in software and AI, moves faster. This gap is acknowledged inside the forum itself, and newer working groups try to address it, but founders should not expect IMDRF or any harmonised framework to provide up-to-the-minute answers on emerging technologies. For those, the national regulators' own recent guidance and expert interpretation matter more than the international reference layer.

## The Subtract to Ship angle on IMDRF

The Subtract to Ship framework applied to IMDRF yields an unusually clean answer. Reading IMDRF documents in your topic area is a high-leverage, low-cost investment that improves every conversation you will have with every national regulator and every consultant. Building a regulatory strategy specifically against IMDRF documents, as if they were binding rules, is waste — because they are not binding, and the real work still has to trace to specific MDR articles and national provisions.

The subtraction is in the trap startups fall into when they first discover IMDRF and assume it is a shortcut. It is not. It is not a pathway. It is not a submission target. It is not an alternative to any national framework. Cut any plan that treats IMDRF as a substitute for reading the MDR or for engaging with the FDA, Health Canada, the TGA, PMDA, or ANVISA on their own terms. Keep the reading. Keep the shared vocabulary. Keep the conceptual alignment. Cut the rest.

See [The Subtract to Ship framework for MDR](/blog/subtract-to-ship-framework-mdr) for the methodology this applies.

## Reality Check — Where do you stand on international harmonization?

1. Do you know what IMDRF is and, at a topic level, which of its working group areas are relevant to your device?
2. Have you read — not skimmed — at least one IMDRF document in the area most relevant to your technology?
3. When you discuss your device with specialists from different jurisdictions, are you using the same vocabulary across all of those conversations, or are you switching mental models each time?
4. Does your multi-market plan treat each target regulator as a separate submission on its own terms, with harmonisation helping the preparatory work but not replacing the submissions?
5. Do you understand the difference between a harmonised concept (like SaMD) and a legally binding rule (like MDR Annex VIII Rule 11)?
6. Is anyone on your team treating IMDRF, or any harmonised framework, as a shortcut to market access?
7. If an investor asked you today to distinguish between the harmonised parts of your regulatory plan and the market-specific parts, could you answer clearly?

If more than three of these produced a "not yet," your multi-market plan is still being built in isolation. The harmonisation layer is waiting for you.

## Frequently Asked Questions

**Is IMDRF a regulator?**
No. IMDRF is a voluntary forum of medical device regulators from around the world. It develops harmonised guidance documents but does not make law, clear devices, inspect manufacturers, or designate conformity assessment bodies. Its output becomes practically relevant only when a national or regional regulator adopts or references it in its own framework.

**Does IMDRF guidance override the MDR?**
No. The MDR (Regulation (EU) 2017/745) is the binding law for medical devices placed on the EU market, together with its annexes, MDCG guidance, and harmonised standards. IMDRF guidance influences the conceptual framework that the MDR sits inside but has no legal force in the EU on its own. Any claim that "IMDRF says X, so MDR Article Y does not apply" is wrong.

**Can I cite IMDRF documents in my technical file?**
You can reference them for conceptual background, but the technical file must be built against the binding requirements — MDR articles, annexes, MDCG guidance, and harmonised standards. A Notified Body reviewing your file is checking compliance with the MDR, not with IMDRF. IMDRF documents are a reading source for understanding, not a citation source for compliance.

**Is MDSAP the same as IMDRF?**
No, but they are closely related. MDSAP is an operational programme in which five participating regulatory authorities accept a single QMS audit performed by a recognised Auditing Organisation. IMDRF is the broader forum in which harmonised concepts — including the conceptual groundwork for programmes like MDSAP — are developed. MDSAP is the most visible practical outcome of IMDRF-style harmonisation.

**Does IMDRF cover the EU, US, Canada, and other major markets?**
The major medical device regulators that most EU startups encounter are represented in IMDRF at different levels of participation. That representation influences the concepts behind each jurisdiction's framework but does not merge the frameworks themselves. Market access in each jurisdiction still requires meeting that jurisdiction's own legal requirements in full.

**How should a startup use IMDRF in practice?**
Read the relevant IMDRF topic-area documents once, early in your regulatory planning. Use them as a shared vocabulary when talking to specialists in different markets. Use them as an early-warning system for concepts that may show up in national guidance in the following years. Do not use them as a substitute for reading the MDR, the FDA regulations, or any other binding framework. Every obligation that applies to your device still traces to a national or regional source — not to IMDRF.

## Related reading

- [How to Build a Regulatory Roadmap for Your MedTech Startup](/blog/mdr-regulatory-roadmap-startup) — where harmonisation considerations sit in the overall timeline.
- [Two-Phase Development Approach](/blog/two-phase-development-approach) — how multi-market planning inherits the sequencing question.
- [The Subtract to Ship Framework for MDR Compliance](/blog/subtract-to-ship-framework-mdr) — the methodology behind the IMDRF reading strategy recommended here.
- [FDA Regulation of Medical Devices: A Primer for EU Startups](/blog/fda-regulation-medical-devices-primer-eu-startups) — the companion primer for the US side of a multi-market plan.
- [MDSAP: Using a Single Audit for Multiple Markets](/blog/mdsap-single-audit-multiple-markets) — the operational outcome of IMDRF-style harmonisation for QMS auditing.
- [FDA vs MDR: the core differences every founder should know](/blog/mdr-vs-fda) — where harmonisation helps and where it stops.
- [Regulatory strategy for startups targeting EU and US markets](/blog/regulatory-strategy-startups-targeting-eu-us-markets) — the dual-market planning companion.
- [Health Canada market access for EU startups](/blog/health-canada-market-access-eu-startups) — why Canada and MDSAP are effectively inseparable, and how harmonisation helps.
- [International QMS expectations for MedTech manufacturers](/blog/international-qms-expectations-medtech) — the broader QMS overlay landscape across jurisdictions.
- [IMDRF-aligned software categorisation for SaMD startups](/blog/imdrf-software-categorisation-samd) — the specific SaMD working-group area and how it lands in MDR practice.

## Sources

1. Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices (MDR), Article 2(1), Article 51, and Annex VIII. Official Journal L 117, 5.5.2017. Cited here as the binding EU framework that sits alongside, and is influenced by, IMDRF conceptual work.
2. MDCG 2019-11 Rev.1 — Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 and Regulation (EU) 2017/746. October 2019; Rev.1 June 2025. Cited as an example of how the EU implements concepts that were shaped at the international level.
3. EN ISO 13485:2016 + A11:2021 — Medical devices — Quality management systems — Requirements for regulatory purposes. The QMS standard that forms the common core across many harmonised frameworks, including MDSAP.
4. EN ISO 14971:2019 + A11:2021 — Medical devices — Application of risk management to medical devices. The risk management standard referenced across multiple jurisdictions and consistent with internationally harmonised principles.
5. International Medical Device Regulators Forum (IMDRF) — public working group documentation and guidance output. Referenced here at the general framing level; for current documents and revisions, consult the IMDRF public site directly.
6. Medical Device Single Audit Program (MDSAP) — program documentation maintained by the participating regulatory authorities. Cited as the most visible operational outcome of IMDRF-style harmonisation for QMS auditing.

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*This post is part of the FDA & International Market Access series in the Subtract to Ship: MDR blog. Authored by Tibor Zechmeister and Felix Lenhard. IMDRF is one of the quiet layers behind modern MedTech regulation — invisible to most founders, obvious to every experienced regulator. Reading it once makes every cross-border conversation clearer. Treating it as a shortcut to market access makes every cross-border plan worse. Use the shared vocabulary. Meet every jurisdiction on its own terms.*

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*This post is part of the [FDA & International Market Access](https://zechmeister-solutions.com/en/blog/category/fda-international) cluster in the [Subtract to Ship: MDR Blog](https://zechmeister-solutions.com/en/blog). For EU MDR certification consulting, see [zechmeister-solutions.com](https://zechmeister-solutions.com).*