The situation
A device exists, or nearly does, and someone has to decide where it will be sold first, under which rules, by which route and with what evidence. The decision is usually made by whoever has the strongest opinion in the room rather than by the rules, and the rules do not forgive that. A class chosen from a competitor's label, a route chosen because the founders know it, a market chosen because a distributor called: each sets the cost of the next two years.
Strategy work exists to replace those defaults with decisions that are written down, referenced to the rule and the guidance, and sequenced so that evidence generated for one market serves the next.
What goes wrong when this is handled late
The expensive failures are familiar. A device classified a class too low reaches a notified body with a file built for the wrong conformity-assessment route. A 510(k) built around a predicate that does not cover the indication becomes a De Novo after the testing budget is spent. A manufacturer enters three markets in sequence and builds three files, when one file built to the most demanding market would have served all three with deltas. An overseas manufacturer appoints an Indian distributor as its authorised agent without understanding that the agent will hold the import licence in its own name.
Every one of these is a strategy decision that was never written down, and therefore never examined.
What Authentcare does
Assess. Qualify the product: is it a medical device, an IVD, an accessory, a combination product, or none of these, in each market? Classify it under each market's rules, with the borderline cases checked against the guidance. Identify the conformity-assessment or premarket route each class allows, the evidence each route demands and the time each typically takes. Identify the standards and guidance that apply, by edition, and the in-country roles each market requires.
Develop. Write the classification and pathway memo. Build the market-sequencing plan that shows which evidence serves which market. Prepare the pre-submission package for an FDA Q-Submission or a notified-body structured dialogue, including the specific questions worth asking and the ones that are better not asked. Set out the representation plan, the registration obligations and the economic-operator duties of your importers and distributors in the EU.
Coordinate. Support the selection of a notified body and the opening conversation with it. Prepare you for the FDA pre-submission meeting and attend it with you. Brief the authorised representative, UK responsible person or Indian authorised agent once appointed. Track the regulatory changes that touch your plan for the six months after delivery, and tell you when one does.
When the regulations are themselves changing
The EU is negotiating a targeted revision of the MDR and IVDR; the current text applies until the amending regulation is adopted and in force. The UK has confirmed long-term recognition of CE-marked devices in Great Britain while its own pre-market regulations are in draft. The EU AI Act's obligations for AI in devices apply from 2 August 2028. A strategy written in 2026 has to be built on what is in force and watch what is proposed, and it has to say which is which. Every memo does.
What you receive
- Classification and pathway memo for up to two markets, with rationale and references
- Market-sequencing plan showing which evidence serves which market and in what order
- Pre-submission strategy and briefing documents for an FDA Q-Submission or a notified-body structured dialogue
- Applicability matrix of regulations, standards (by edition) and guidance for the device
- Representation plan naming the in-country roles each market requires and how to appoint them
- FDA establishment registration and device listing guidance; EU economic-operator obligations for importers and distributors (MDR Articles 13 and 14)
- Regulatory-change impact assessments for the engagement's frameworks
Frameworks and editions
Applicability is device-specific. Which of these apply, and in what combination, depends on device type, intended purpose, classification and target market; the applicability assessment at the start of every engagement settles it in writing.
| Reference | Edition or version cited | Where it applies |
|---|---|---|
| EU MDR 2017/745 and IVDR 2017/746 | As amended, including Regulations (EU) 2023/607 and 2024/1860; targeted revision proposed (COM(2025) 1023, under negotiation, current text applies) | EU qualification, classification, conformity assessment routes, economic-operator obligations |
| 21 CFR Parts 807, 814 and 860; FD&C Act section 513(f)(2) | Current CFR | US 510(k), PMA, De Novo, classification and product codes |
| FDA Q-Submission Program guidance | Current FDA guidance | Pre-submission meetings and written feedback |
| India Medical Devices Rules 2017 | As amended | Indian classification, licensing authority and route |
| UK Medical Devices Regulations 2002 | As amended; draft Medical Devices (Amendment) Regulations 2026 under consultation | Great Britain route, CE recognition and UKCA |
| Singapore Health Products Act and HSA guidance; TGA Therapeutic Goods (Medical Devices) Regulations 2002; Health Canada SOR/98-282 | Current | Secondary markets in a sequencing plan |
What this engagement excludes
- Preparing the submission itself; that is a technical documentation or project engagement
- Notified-body, FDA, CDSCO and other regulator fees
- Acting as a statutory representative in any market
- Legal advice on contracts, distribution agreements or liability
Boundary
Authentcare advises on and prepares submissions; regulators and notified bodies decide.