Medical device regulatory intelligence, answered with the source
RegAffairs AI gives you medical device regulatory intelligence as one cited answer in seconds, across FDA, EU and UK sources.
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Ask about the FDA product code on your desk, a 510(k) clearance, an MDR classification rule or a UK deadline. RegAffairs AI answers in plain language and shows the research trail. Open a citation to check the source document, then ask the next question.
Ask the FDA product code database and 510(k) database questions together
Product classification and clearance research belong in the same answer. Ask: "What is FDA product code DQY, what device class and regulation number is it, and list a few recent 510(k) clearances under it with K numbers."
- Device name: Catheter, Percutaneous.
- Class II, regulation 21 CFR 870.1250, 510(k) pathway.
- Premarket review division: DHT2C.
- Recognized standards include ISO 10555-1 and ISO 10555-4 (2023).
- Relevant K numbers, including K252297, linked to FDA's clearance letters.
The question you'd take to the FDA 510(k) database comes back with classification details and clearance sources together. Start predicate research with records you can open.
EU MDR and IVDR questions, cited to the act
Get the classification rule or transition date with its legal source attached. These live answers show how:
Software classification: The MDR Rule 11 answer explains Class IIa for software informing diagnostic or therapeutic decisions. Class IIb or III depends on the consequences set out in Annex VIII. It cites MDCG 2019-11 rev. 1, June 2025.
IVDR transitions: The companion diagnostic answer explains Class C and medicines authority consultation. Eligible legacy IVDs meeting Regulation (EU) 2024/1860's conditions have these deadlines: 31 December 2027 for Class D, 2028 for Class C, and 2029 for Class B and sterile Class A.
EUDAMED: The module answer names the four modules mandatory since 28 May 2026. They are actor registration, UDI/device registration, notified bodies and certificates, and market surveillance. It links the requirement to Commission Decision (EU) 2025/2371.
FDA, EU and UK in one answer
Ask how your device's classification or market-access rules compare across jurisdictions. See EU MDR Rule 11 alongside FDA's clinical decision support criteria, with each position cited.
For Great Britain, this market-access answer explains CE-mark acceptance and MHRA registration before market placement:
- MDD/AIMDD devices: until certificate expiry or 30 June 2028, whichever comes first.
- IVDD devices: until expiry or 30 June 2030, whichever comes first.
- EU MDR/IVDR devices: until 30 June 2030.
Medical device compliance software that starts with your question
Medical device regulatory software should be useful on the first visit. Enter the question you're researching and check the cited answer.
| Research task | RegAffairs AI | Separate official-source searches |
|---|---|---|
| Classification and clearances | Ask for product code details and K numbers together | Search classification records and clearance letters separately |
| Cross-market research | FDA, EU and UK positions in one answer | Read and compare each regulator's records |
| Research trail | Citations beside the answer's claims | Collect source links as you search |
Medical device regulatory intelligence for your team
- RA specialists: "Which 510(k) predicates share product code QJP, and what recognized standards apply?"
- EU market-access teams: "Which legacy deadline applies to our Class C IVD under Regulation (EU) 2024/1860?"
- QA teams: "What changed in the June 2025 revision of MDCG 2019-11?"
- Consultancies and authorised representatives: "Does my Class I device need a 510(k), or is it exempt?"
For companion diagnostics and combination products, explore RegAffairs AI for pharma. Ask in the language of your file.
FAQ
How does it help with 510k database research?
Ask about a product code or device and get relevant clearances, with K numbers linked to FDA's clearance letters.
Does it answer EU MDR, IVDR and EUDAMED questions?
Yes. Ask about classification rules, transition deadlines or EUDAMED module dates. Open the cited EUR-Lex or European Commission source from the answer.
How much does it cost?
Free to try, no credit card. Pro is $100 per user per month, with unlimited questions and deep research, cancel anytime. Enterprise seats, SSO and procurement are available on request.
Is my data used to train models?
No. Questions and uploads are never used for training. Data is processed and stored in the EU by default. Read the security details.
Ask your first device question
Start with your product code, clearance question or market-access deadline. Get the answer with its sources attached.