The device can be brought onto the market until the date of validity on the MDD/AIMD certificate. Until this date, it only has to comply with the MDD. After this date, the device should comply with all the rules of the MDR, and it should have a valid CE certificate according to the MDR.

Note: as of 26th of May 2021, organizations will have to comply with the requirements for post-market surveillance, market surveillance, vigilance and the registration of economic operators and devices (see articles 29-31 and 83-100 in the MDR).

From the day after the date on the certificate

From the 27th of May 2024, the device will have to comply with all MDR rules and have a valid CE certificate according to the MDR.

Note: As of the 26th of May 2021, organizations will have to comply with the requirements for post-market surveillance, market surveillance, vigilance and the registration of market participants and devices (see articles 29-31 and 83-100 in the MDR).

From the 27th of May 2024

As soon as the device with the significant change is placed on the market, it will immediately have to comply with all MDR rules and have a valid CE certificate according to the MDR.

Note: As of 26th of May 2021, organizations will have to comply with the requirements for post-market surveillance, market surveillance, vigilance and the registration of economic operators and devices (see articles 29-31 and 83-100 in the MDR).

From the moment of release of the changed device

The device will have to comply with all the MDR rules from May 26, 2021.

From the 26th of May 2021

From May 27, 2022, the device must comply with all MDR rules and have a valid CE certificate according to the MDR.

Note: As of May 27, 2021, organizations will have to comply with the requirements for post-market surveillance, market surveillance, vigilance and the registration of market participants and devices (see articles 29-31 and 83-100 in the MDR).

From the 27th of May 2022

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The MDR was published on the 26th of May 2017, and is effective from the 26th of May 2021, but when will my medical device have to meet the new requirements?

When does my medical device have to comply with the MDR?

Will this device be subject to a significant change after the 26th of May 2021?

Does the device have an MDD CE Certificate according to Annex IV (batch verification)?

Is the MDD/AIMD CE Certificate valid until a date before the 27th of May 2024?

Is the device already on the market before the 26th of May, 2021?

Is the device class Im (with measurement function), Is (sterile), Ir (reusable/reusable surgical tool), IIa, IIb, or III, according to the MDR?

Is the MDD/AIMD CE Certificate valid untill a date before the 27th of May 2022?

Will the device be subject to a significant change after the 26th of May 2021?

Is it a class I device according to the MDD, and not class Im (with measurement function) or class Is (sterile)?