The device regulatory map at a glance
Medical device rules follow the product lifecycle. The table maps each stage to the main source in each region and the global standards behind them. Each link goes to a detailed article.
| Lifecycle stage | Japan | United States | European Union | Global |
|---|---|---|---|---|
| Market access law | PMD Act | FD&C Act and 21 CFR | MDR 2017/745 | IMDRF |
| Quality management system | QMS Ordinance (MO169) | QMSR, 21 CFR 820 | MDR Article 10 and harmonised ISO 13485 | ISO 13485 |
| Risk management | QMS Ordinance | QMSR (risk management now explicit) | MDR Annex I | ISO 14971 |
| Software and electrical safety | PMDA guidance | FDA guidance | MDCG guidance | IEC 62304, IEC 60601 |
| Interpretation and guidance | PMDA guidelines | FDA guidance | MDCG guidance | IMDRF documents |
| Registration and databases | e-Gov Law Search (law text) | FDA databases | EUDAMED | — |
| Inspection and enforcement | PMDA and prefectural inspections | Form 483, warning letters | Notified bodies and competent authorities | — |
What changed for device makers in 2025 and 2026
| Date | Change | Region |
|---|---|---|
| 16 Dec 2025 | Commission proposes targeted MDR/IVDR simplification (not yet law; adoption expected around Q2 2027) | EU |
| 2 Feb 2026 | QMSR takes effect; ISO 13485:2016 incorporated by reference; QSIT retired | US |
| 28 May 2026 | Four EUDAMED modules become mandatory | EU |
| May 2026 | Further stage of the 2025 PMD Act amendment takes effect | Japan |
| 2026 | Many new MDCG documents on UDI, EUDAMED, and EMDN | EU |
| Sep 2026 | IEC 62304 edition 2 expected date moves to 26 October 2028 | Global |
| 31 Dec 2027 | MDR legacy deadline for class III and class IIb implantable devices | EU |
| 31 Dec 2028 | MDR legacy deadline for other class IIb, IIa, Im, and Is devices | EU |
The big theme: ISO 13485 is now the common QMS baseline in all three regions. Japan aligned its QMS Ordinance in 2021, the EU relies on the harmonised standard, and the US joined in February 2026. That makes cross-region QMS work easier, but it also means more teams want ISO text in their AI tools, which ISO’s licence does not allow without permission.
AI use terms for device sources
| Source | AI and RAG use |
|---|---|
| FDA regulations and guidance | Public domain unless noted; tag draft vs final |
| eCFR | Reusable; not the official legal edition, so record the “as of” date |
| MDR and MDCG | CC BY 4.0 with attribution; only the Official Journal is authentic; keep MDCG separate from the law |
| EUDAMED | Check required: operator and personal data |
| PMDA guidelines | PDL1.0, but crawling and bulk download prohibited |
| IMDRF | Internal, non-commercial use only without permission |
| ISO 13485, ISO 14971 | No AI or ML use without a separate licence, including prompting and querying |
| IEC 62304, IEC 60601 | No use in public or private AI tools without IEC’s express permission |
Building a device knowledge base
- Make QMSR, MDR, and the QMS Ordinance the core, each with its version date.
- Map your procedures to ISO 13485 clause numbers without loading ISO text.
- Archive pre-February 2026 Part 820 (QSR) text and label it superseded.
- Keep MDCG and FDA guidance as a separate, nonbinding layer.
- Store the 2025 EU proposal as “proposed,” not current law.
- Track deadlines: end 2027 and end 2028 MDR legacy dates, EUDAMED modules still to come, IEC 62304 edition 2.
How AskDona helps
AskDona checks your quality manual, technical files, and software lifecycle records against QMSR, MDR, and the QMS Ordinance in one pass, citing each requirement to its region and version. It works on your own documents, so licensed ISO and IEC text stays out unless your licence allows it.
Run a sample three-region device QMS check
AskDona shows the evidence; your regulatory team decides.
Editor’s note. This article is general information, not legal advice. Status and terms summarize the detailed articles linked above, each checked against official or primary pages by October 26, 2026.
FAQ
Is ISO 13485 now required in the US? Yes, in practice. The QMSR, effective 2 February 2026, incorporates ISO 13485:2016 by reference.
When must legacy devices be MDR certified? By 31 December 2027 for class III and IIb implantables, and 31 December 2028 for other classes, if conditions are met.
Can I put ISO 13485 or IEC 62304 into my AI tool? Not without permission. Both ISO and IEC restrict AI use in their licence terms.
Which EUDAMED modules are mandatory? Actor registration, UDI and device registration, notified bodies and certificates, and market surveillance, since 28 May 2026.
References
All pages opened and checked by October 26, 2026. Each linked article lists its own primary sources.
| Source | What it supports |
|---|---|
| FDA: QMSR | QMSR effective 2 Feb 2026; ISO 13485 by reference |
| Regulation (EU) 2023/607 | MDR legacy deadlines |
| Baker McKenzie: EU 2025 MDR/IVDR proposal | Proposal date and expected adoption |
| European Commission: EUDAMED overview | Mandatory modules |
| European Commission: MDCG guidance | 2026 MDCG documents; not legally binding |
| ISO: Licence agreement | AI and ML restrictions |
| IEC Webstore: Terms and conditions | AI restrictions |
| QuickBird Medical: IEC 62304 edition 2 delayed | Expected date 26 Oct 2028 |
| IMDRF Document Implementation Report 2026 | IMDRF terms |