Quick Answer
CE marking for medical devices under EU MDR 2017/745 confirms a device meets EU safety and performance requirements. The process depends on device class (I, IIa, IIb, III); higher classes require a notified body. Verify the CE certificate and notified-body number, and confirm it covers the specific device.
CE / MDR Essentials
- MDR 2017/745 governs medical device CE marking in the EU
- Device class (I to III) determines the conformity route
- Higher-risk classes require a notified body (with a 4-digit number)
- Verify the certificate and that it covers the specific device
MDR is stricter than the previous directive. Confirm the device class and notified-body involvement. See verifying CE.
Key Takeaways
- MDR 2017/745 governs EU medical device CE marking.
- Device class sets the conformity route.
- Higher classes need a notified body.
- Verify the certificate covers the specific device.
Frequently Asked Questions
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, especially for clinical evidence and oversight.
How does device class affect CE marking?
Class I devices can often self-declare; Class IIa, IIb, and III devices require a notified body to assess conformity. Higher risk means more rigorous assessment.
How do I verify a medical device CE certificate?
Confirm the notified-body number in the EU NANDO database, check the certificate covers the specific device and class, and confirm validity. Do not rely on a PDF alone.
Is CE marking enough to sell a device in the EU?
CE marking under MDR is the core requirement, but registration, labelling, and a quality system (ISO 13485) also apply. Confirm the full set of obligations.
Can Plutonia verify medical device CE marking?
Yes. Plutonia verifies CE/MDR certificates and notified-body involvement for the specific devices you are sourcing. Submit the product details to start.