Product compliance · MDR + FDA + ISO 13485
Medical devices and health products
Technical file, clinical evaluation and quality-system evidence for MDR, FDA and other device regimes.
Key facts
| EU route | MDR 2017/745, CE marking, notified body for most classes |
|---|---|
| US route | FDA establishment registration, listing, 510(k) or PMA |
| Other markets | Health Canada licence, TGA inclusion, PMDA approval |
| Core documents | Technical file, clinical evaluation, risk management file |
| Quality system | ISO 13485 evidence is the usual baseline |
| Recurring | Post-market surveillance, UDI and registration renewals |
| Typical one-off budget | USD 3,000–30,000+ depending on class |
| Last verified | 2026-10-17 |
Class decides the route and the timeline
A low-risk device may be self-certified under the EU MDR, while a higher class needs a notified body and a clinical evaluation. The US uses a different class system, with 510(k) clearance for many moderate-risk devices and PMA for high-risk ones. The same product can therefore be a different class in each market.
The technical file and the quality system are the backbone. A test report alone does not demonstrate clinical safety or performance, and a notified body will ask for the risk management and post-market plan.
Registration is not a one-time event
Device registrations, listings and certificates have renewal cycles, and changes to the device can trigger a new assessment. Post-market surveillance, vigilance reporting and UDI requirements continue after launch, which makes the recurring cost and the internal ownership as important as the initial approval.
For a small seller, the usual route is a partner or distributor that already holds the registration in the destination. That shifts the operational burden but does not remove the need to keep the technical file current.
Frequently asked questions
Can I sell a wellness device without medical registration?
The classification depends on the intended use and the claims. A product that claims to diagnose or treat a condition is likely to be regulated as a device; the wording on the label and the listing matters.
Is ISO 13485 mandatory?
It is not always named in the regulation, but it is the recognised quality-system standard and is effectively expected by notified bodies and many buyers.
Can I reuse an EU technical file for the US?
Parts can be reused, but the classification, the submission route and the labelling differ. Plan a gap assessment rather than a straight copy.
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