A MedTech startup passes through roughly 14 recognisable milestones from idea to first euro. Each one unlocks something specific — a funding tranche, a hire, a partnership, a next-stage conversation. Founders who track these milestones explicitly raise more capital with less friction, because investors recognise the shape of the path.

By Tibor Zechmeister and Felix Lenhard.

TL;DR

  • The MedTech idea-to-market path is a sequence of roughly 14 milestones, not a single "build the product" phase.
  • The earliest regulatory milestones — intended purpose definition and classification — unlock the biggest strategic decisions and are often skipped.
  • QMS certification, CER completion, and Notified Body engagement each unlock specific funding tranches in most MedTech term sheets.
  • The CE certificate is a milestone, not the finish line. EUDAMED registration and first commercial sale are distinct events that follow.
  • Tracking milestones explicitly, with dates and owners, is the cheapest valuation multiplier a MedTech founder has.

Why this matters

Investors do not fund products. They fund milestones. A MedTech startup that can say "we are at milestone 7 of 14, and here is what unlocks when we hit milestone 8" is a fundable startup. One that cannot is a slide deck.

The MDR does not describe startups in these terms — it describes manufacturer obligations. But those obligations naturally sequence into milestones that mirror how capital, hiring, and partnerships actually flow in the real world. This post maps the two together.

What MDR actually says about the milestones

The MDR does not list "startup milestones." It lists obligations. The relevant anchors are:

  • Article 10 — general obligations of manufacturers: QMS, technical documentation, risk management, clinical evaluation, PMS, PRRC, Declaration of Conformity.
  • Article 52 — conformity assessment procedures, which differ by class and drive whether a Notified Body is involved at all.
  • Article 61 and Annex XIV — clinical evaluation requirements, which anchor the CER milestone.
  • Article 33 — EUDAMED, the European database where manufacturers, devices, certificates, and vigilance data are registered.

Each obligation, mapped against how a company actually builds itself, produces a milestone. A milestone is a point where something external changes — a document is signed, a certificate is issued, a registration is filed, an audit is passed. Internal progress is not a milestone. External acknowledgement is.

The 14 milestones

Here is the path, in order, with what each one unlocks.

1. Intended purpose locked. A single paragraph that defines what the device is for, who uses it, and in what environment. Article 2(12) is the legal definition. This milestone unlocks classification, clinical evaluation strategy, and the first honest conversation with potential investors. Most founders skip it and pay for it later.

2. Classification justified. A written classification rationale citing the specific Annex VIII rule and the reasoning. This is the document a Notified Body will ask for on day one. Unlocks: route-to-market clarity, budget sizing, Notified Body shortlist.

3. Regulatory strategy signed off. A document that names the conformity assessment route, the Notified Body target, the clinical evaluation approach, and the country of first launch. Unlocks: the regulatory slide in your pitch deck — which most pre-seed investors now expect.

4. Pre-seed closed. Typically 500k to 1.5M EUR in Europe. Unlocked by milestones 1 through 3 plus a credible founding team. This is the capital that pays for the next five milestones.

5. Risk management file opened. The first formal risk analysis under EN ISO 14971:2019+A11:2021. Not a spreadsheet — a living file with hazards, harms, sequences of events, and control measures. Unlocks design decisions with proper traceability.

6. QMS operational. A minimum viable QMS under EN ISO 13485:2016+A11:2021, with procedures for document control, design controls, supplier management, CAPA, and internal audits. Unlocks: Notified Body engagement, serious hiring, and the Stage 1 audit.

7. Technical documentation drafted (Annex II and III). Device description, intended purpose, design and manufacturing information, GSPR checklist, preclinical and clinical data, labelling, risk management summary, PMS plan. Unlocks: Notified Body submission.

8. Clinical Evaluation Report (CER) v1 complete. A systematic evaluation under Article 61 and Annex XIV, with state-of-the-art section, equivalence analysis (if claimed), and benefit-risk conclusion. Unlocks: Notified Body review of clinical data. This is often the milestone that slips.

9. Notified Body engaged and contract signed. Not just a conversation — a signed contract, a file number, and a reviewer assigned. Unlocks the most important thing in the MedTech fundraising cycle: the Series A conversation. Most European MedTech VCs will not close a Series A until the NB is contractually engaged.

10. Stage 1 audit passed. Documentation review complete, no critical findings. Unlocks: Stage 2 audit scheduling and the next funding tranche.

11. Stage 2 audit passed. QMS on-site audit complete, findings closed. Unlocks: technical documentation review, which for Class IIa and above is where the Notified Body digs into the CER, the risk file, and the GSPR evidence.

12. CE certificate issued. The legal permission to place the device on the EU market. Unlocks: Declaration of Conformity, CE marking on the product, manufacturer registration.

13. EUDAMED registration complete. Manufacturer registered, Basic UDI-DI assigned, device registered. Under Article 33 and the related implementing regulations. Unlocks: lawful commercial activity across member states (though national registration may still apply in some markets).

14. First commercial sale invoiced. The first real customer transaction. Not a pilot, not a research collaboration — a purchase order with a price and an invoice. Unlocks: revenue multiples in valuation, and the Series B conversation.

A few founders add a fifteenth milestone — first reimbursement code granted — because in many markets that is the real unlock for hospital sales. Whether you count it depends on your business model.

A worked example: an active therapeutic wearable

Imagine a Class IIa active therapeutic device. Here is how the milestones sequenced in a real (anonymised) case we worked with.

  • Milestones 1 to 3: months 0 to 4. Delayed by two months because the founders resisted narrowing the intended purpose. Classic mistake.
  • Milestone 4: month 5. Pre-seed closed at 900k EUR.
  • Milestones 5 to 7: months 5 to 14. Parallel workstreams. The risk file opened in month 6, QMS operational by month 10, tech doc draft by month 14.
  • Milestone 8: month 16. CER v1 complete. Two months late because equivalence evidence was weaker than expected.
  • Milestone 9: month 17. Notified Body contract signed. Series A term sheet dated one week later — not a coincidence.
  • Milestone 10: month 22. Stage 1 audit. Five months in the Notified Body queue.
  • Milestone 11: month 25. Stage 2 passed with three findings, closed in six weeks.
  • Milestone 12: month 30. CE certificate issued.
  • Milestone 13: month 31. EUDAMED complete.
  • Milestone 14: month 36. First paid pilot converted to commercial sale. Six months of hospital procurement cycle.

Thirty-six months from founding to first euro. Eight investor updates. Two bridge rounds. This is the honest shape of the path. It is slower than a SaaS startup — but it is predictable, and predictability is its own form of speed.

The Subtract to Ship playbook

Most founders track the wrong milestones. They track internal progress ("feature X is done") instead of external milestones ("a Notified Body has signed a contract"). Here is how to do it differently.

Write the 14 milestones on a single page. Not a Gantt chart. A single page with each milestone, its owner, its target date, and its current status. Share it with your board every month. Cheap, boring, and ruthlessly effective.

Map each milestone to the specific MDR article or annex that anchors it. This is the Subtract to Ship discipline: every activity must trace to a regulatory obligation. If it does not, ask why you are doing it.

Name the unlock explicitly. For each milestone, write down what it unlocks — the funding tranche, the hire, the partnership conversation. If a milestone unlocks nothing, it is not really a milestone.

Do not count internal milestones as external ones. "QMS drafted" is not "QMS operational." "CER draft" is not "CER v1 complete and reviewed." Investors will ask, and the answer matters.

Subtract milestones that do not unlock anything. If you catch yourself adding milestones to look busy, you have lost the thread. Fewer, sharper milestones beat a crowded dashboard every time.

Run milestones 5 through 8 in parallel. Risk management, QMS, technical documentation, and CER are not serial — they inform each other. Treating them as a waterfall costs you 6 to 9 months.

Reality Check

  1. Can you list your current position on the 14-milestone path in one sentence, without hedging?
  2. Does every milestone on your roadmap trace to a specific MDR article, annex, or obligation?
  3. Have you written down what each milestone unlocks in terms of capital, hires, or partnerships?
  4. Is your Notified Body contract signed, or are you still in "conversations"?
  5. Does your board deck show the 14 milestones with honest dates, or does it show only the optimistic ones?
  6. Is your CER a living document with a version number, or a Word file someone drafted once?
  7. When you hit a milestone, do you actually communicate the unlock externally — to investors, customers, partners?

Frequently Asked Questions

Why 14 milestones and not 10 or 20? Fourteen is the number of externally recognisable events most MedTech startups pass through. You can split them finer or coarser, but the shape stays the same.

Do Class I devices follow the same milestones? Mostly, minus the Notified Body ones (milestones 9 through 11). A self-certified Class I device still needs intended purpose, classification, QMS, technical documentation, and CE marking.

What if I pivot mid-path? You restart from whichever milestone the pivot invalidates. A pivot that changes the intended purpose sends you back to milestone 1. A pivot that only changes the go-to-market strategy does not.

When do I hire a PRRC? Before milestone 6. You cannot demonstrate a compliant QMS without a PRRC identified, per Article 15.

Should I pay for external help at each milestone? At milestones 2, 3, 8, and 9 specifically. Those are where the cost of a mistake is highest and the cost of expert review is lowest relative to the benefit.

Is EUDAMED really a separate milestone from CE? Yes. CE gives you the legal basis; EUDAMED gives you the database presence. Both are required before lawful commercial distribution.

Sources

  1. Regulation (EU) 2017/745 on medical devices, consolidated text. Articles 10, 15, 33, 52, 61, Annex II, Annex III, Annex VIII, Annex XIV.
  2. EN ISO 13485:2016+A11:2021 — Medical devices QMS requirements.
  3. EN ISO 14971:2019+A11:2021 — Application of risk management to medical devices.