The EU MDR transition has set a phased deadline that runs past 2027, which means a device placed on the EU market under the older Directive has to be moved to the Medical Device Regulation by a set window. The deadline depends on the device class and the certificate, so it is not one date for everyone.
Why the MDR timeline matters
The Medical Device Regulation (MDR) replaces the older active implantable and medical device Directives. A device already on the market can continue to be sold under the Directive for a transition period, but the period is capped and it is not the same for every device. A surgical table or an OR light falls into a class, and the transition window for that class sets when it must comply with MDR.
Deadline drivers compared
| Driver | How it sets the date | Por qué es importante |
|---|---|---|
| Device class | Higher class, later date | Sets the transition window |
| Certificate | Current vs expired | An expired certificate fails |
| Notified body | Disponibilidad | Sets the audit timing |
| Market | EU placement | Rules apply on the EU market |
The device class and the certificate are the two drivers. A higher-class device gets a later transition window, and a device with an expired certificate is no longer on the market. Confirm the class of your device and the state of your certificate, because that is what sets your date.
For a device sold into the US, the US quality system for medical devices is a separate, overlapping set of rules, so a device has to meet the requirements of each market it enters.
See the US Federal Trade Commission on commercial claims for the accuracy behind a compliance claim.
OEM: an MDR transition term
| Commercial term | Typical range |
|---|---|
| MOQ (per device) | 1-10 units |
| Technical file review | 30-60 days |
| Bulk | 40-60 days |
| Packing | Carton + pallet |
Confirm the MOQ, the technical file review and the bulk time before you commit. Exact MDR class, certificate state and transition date: 〔待工厂确认〕.
If you want to plan a device compliance timeline, see our medical device range so the class and the transition line up.
FAQ about the EU MDR transition
What is the EU MDR transition?
The phased move of devices from the older EU medical device directives to the Medical Device Regulation, with a transition window that depends on the device class.
Is there one deadline for all devices?
No. The deadline depends on the device class and the certificate, so a higher-class device gets a later window and a device with an expired certificate is no longer on the market.
What sets my transition date?
The device class and the state of your certificate. Confirm the class of your device and whether the certificate is current.
What happens if I miss the deadline?
The device can no longer be placed on the EU market under the Directive, so it must comply with MDR. Confirm the class and the certificate to avoid the gap.
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