Quick Answer
The main medical device certifications are CE marking under the EU Medical Device Regulation (MDR 2017/745) for the EU, FDA 510(k) clearance for the US, and ISO 13485 for the manufacturer's quality management system. CE and FDA relate to the device; ISO 13485 relates to the factory's QMS. Verify each with the issuing body.
The Three Key Certifications
| Certification | Scope | Market |
|---|---|---|
| CE (MDR 2017/745) | Device conformity | EU |
| FDA 510(k) | Device clearance | US |
| ISO 13485 | Manufacturer QMS | Global |
ISO 13485 certifies the quality system, not the device — a manufacturer can hold it while a specific device still needs CE or FDA clearance. Verify device clearances and QMS certificates separately with the issuers. See our healthcare procurement hub.
Key Takeaways
- CE (MDR) for EU, FDA 510(k) for US, ISO 13485 for QMS.
- ISO 13485 certifies the factory, not the device.
- Verify device clearances and certificates with issuers.
- Confirm certification covers the specific device.
Frequently Asked Questions
What certifications do medical devices need?
Typically CE marking under MDR 2017/745 for the EU, FDA 510(k) clearance (or other pathway) for the US, and ISO 13485 for the manufacturer's quality management system — verified with the issuing bodies.
Does ISO 13485 mean a device is approved?
No. ISO 13485 certifies the manufacturer's quality management system, not any specific device. A device still needs CE marking or FDA clearance for its market.
What is FDA 510(k)?
510(k) is an FDA premarket submission demonstrating a device is substantially equivalent to a legally marketed device, allowing it to be cleared for the US market.
What is MDR 2017/745?
MDR 2017/745 is the EU Medical Device Regulation governing CE marking of medical devices, with stricter requirements than the previous directive, often involving a notified body.
Can Plutonia verify medical device certifications?
Yes. Plutonia verifies CE/MDR, FDA 510(k), and ISO 13485 with the issuing bodies for the specific devices and manufacturers you are sourcing. Submit the product details to start.