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Device-to-Market Journey

The Road to Market

Seven Stages from Concept to CE Mark — and Beyond

However a device looks from the inside, it travels the same seven-stage road under EU MDR — classification, quality management, technical documentation, clinical evidence, conformity assessment, CE marking, and post-market surveillance. What changes with risk class is how much evidence each stage needs, not the shape of the journey. This is the map I walk clients through from their very first conversation.

The Journey at a Glance
7 Stages
Classification through post-market surveillance — the same shape for every device class
Class I–III
From self-certification to full Notified Body conformity assessment
No Finish Line
Post-market surveillance runs for as long as the device is on the market
The Journey

Seven Stages, One Predictable Road

Every device — Class I to Class III, hardware or software, legacy or AI-enabled — follows the same seven-stage route to market. The map below is the same one I use with clients on day one.

The seven-stage road from device classification to post-market surveillance. Risk class changes how much evidence each stage needs — not the route itself.
The Stages

From Concept to CE Mark

Each stage builds on the last. Skipping ahead — starting technical documentation before classification is settled, for example — is the most common cause of rework later.

Stage 1
Classify the device
Confirm the product meets the legal definition of a medical device, and determine its risk classification — Class I, IIa, IIb or III — under EU MDR Annex VIII. This decision shapes every stage that follows.
Stage 2
Build the quality management system
Establish an ISO 13485-based QMS covering design control, document and record control, supplier management, and CAPA — the backbone the rest of the technical file sits on.
Stage 3
Compile the technical documentation
Assemble the Annex II/III technical file — device description, design and manufacturing information, risk management file, verification and validation evidence, and labelling.
Stage 4
Demonstrate clinical evidence
Build the clinical evaluation under Article 61 and Annex XIV — literature review, equivalence or clinical investigation data, and a Post-Market Clinical Follow-up (PMCF) plan proportionate to the device's risk.
Stage 5
Undergo conformity assessment
For Class Is/Im/Ir, IIa, IIb and III devices, a Notified Body reviews the QMS and technical file under the applicable route; Class I devices (non-sterile, non-measuring) self-certify.
Stage 6
Affix the CE mark and register
Sign the Declaration of Conformity, apply the CE mark, assign a UDI, and register the device, economic operators and certificate in EUDAMED before placing it on the market.
Stage 7
Maintain post-market surveillance
This is not a finish line — run the PMS plan, PSUR/PMCF reporting, and vigilance and field safety corrective action processes for as long as the device is on the market.
Worth Knowing

The Road Doesn't Change — the Traffic Does

Risk classification doesn't add or remove stages — it changes how much scrutiny each one gets.

Lower Risk — Class I

Lighter Traffic

Non-sterile, non-measuring Class I devices can self-declare conformity — no Notified Body involvement — but the QMS, technical file, and post-market obligations still apply in full.

Higher Risk — Class IIa to III

Heavier Traffic

Notified Body review deepens with risk — from sampling technical documentation at Class IIa to full quality system and design dossier scrutiny at Class III — and clinical evidence expectations rise to match.

Get Started

Walking This Road, Together

Whether you're mapping this journey for the first time or you're deep into technical documentation and need a second pair of eyes, I help medical device organisations move through each stage with confidence.

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