What usually goes wrong when this is left late
Three patterns repeat. A team picks a class from a competitor's labelling and designs the quality system, the testing budget and the fundraising timeline around it, then learns from a notified body that a single sentence in the intended purpose moves the device up a class. A team builds for the FDA because the founders know the 510(k) route, then finds the predicate they relied on does not cover their indication, and a De Novo was always the honest answer. A software team ships a "wellness" product with a feature that triages, and discovers that the feature, not the product, is what regulators classify.
Each of these costs months. Each is avoidable by writing down the qualification and classification reasoning before the design freezes, and testing it against the borderline guidance in each market.
The first two weeks
The scoping call takes thirty minutes and needs no documents; a description and a sentence about the markets is enough. Within three working days you have a written scope. On commissioning, you supply the five inputs listed below, most of which already exist in your pitch materials. Ten working days later you have the memo and a walkthrough call. Nothing in those two weeks requires you to stop building.
What the memo is for
It is written to be handed on: to an investor's diligence adviser, to a notified body in a structured dialogue, to a contract manufacturer asking what quality system they need to support, to a future regulatory hire who needs to know why decisions were made. Every conclusion carries the rule it rests on and the guidance that interprets it, by edition, so that when a rule changes you can see which conclusions it touches.
After the memo
Most startups go one of three ways. Those with a clear pathway and a fixed design commission the technical documentation project, built to the more demanding of their two markets. Those still iterating keep the memo as the regulatory input to design and come back when the design freezes, often for a risk management file first. Those whose device turned out to be higher-risk than expected use the memo to re-plan evidence generation before spending on testing. All three are better positions than the one on the deck that said "TBD".
The first deliverable
Classification and pathway memo
- Objective
- Settle the device's qualification, class and route to market in up to two target markets, with the reasoning written down.
- Scope
- Qualification (is it a medical device, an IVD, an accessory, or none of these); classification under the rules of each market; pathway options with their evidence demands and typical timelines; the standards and guidance that apply, by edition; the representative and registration each market needs; recommended next steps in order.
- What you supply
- Intended purpose as you would print it; device description with drawings or photographs; the claims you intend to make; target markets; any existing test data.
- What you receive
- A memo of six to ten pages with the rationale and the references for each conclusion, issued under document control, plus a 30-minute walkthrough call.
- Excludes
- Submission preparation; notified-body, FDA or CDSCO fees; representative fees; a third market (quoted separately).
- Timeline
- 10 working days from receipt of all inputs
- Terms
- Written quotation after the scoping call; 50% on commissioning, 50% on delivery; one revision round within ten working days of delivery.
The memo is a decision document. It is not a technical file, a 510(k), a design dossier or a licence application, and it does not predict a regulator's decision. It tells you which of those you need, in what order, and why.
Frameworks that usually apply
Which of these apply depends on device type, intended purpose, classification and target market; the memo settles it for your device.
| Reference | Edition or version cited | Where it applies |
|---|---|---|
| EU MDR 2017/745 | As amended, including Regulations (EU) 2023/607 and 2024/1860; Annex VIII classification rules | Qualification and classification for the EU |
| EU IVDR 2017/746 | As amended; Annex VIII classification rules | IVDs for the EU |
| FD&C Act and 21 CFR Parts 807, 814 and 860 | Current CFR; section 513(f)(2) of the FD&C Act for De Novo | US classification, product codes and premarket pathway |
| India Medical Devices Rules 2017 | As amended, with the First Schedule classification and CDSCO's classification notices | Indian risk class A to D and the licensing authority |
| MDCG 2021-24 | Current revision | EU classification guidance |
| MDCG 2019-11 | Current revision | Qualification and classification of software |