Is it worthwhile to CE mark to the IVDD, so close to the IVDR’s date of application?

There is a potentially significant advantage for manufacturers that can CE mark to the IVDD before the DoA.

The progressive IVDR rollout gives manufacturers with upclassed devices the opportunity to take advantage of the longer transition times to comply with the IVDR.

For example, if you launch a new Class C device, such as a Dengue or Zika test, under the IVDR the device requires CE marking through a Notified Body. However, under the IVDD, this device is self-certified. Meaning the manufacturer develops the technical documentation and then self-affixes CE marking without Notified Body involvement, allowing for a significantly quicker time to market.

Therefore, if you can IVDD CE mark the device before the IVDR DoA, the device will be eligible for the progressive rollout transition period. You then have until the deadline for Class C devices (26 May 2026) to obtain IVDR CE marking through a Notified Body. In the meantime, you can continue commercializing the IVDD CE marked device in Europe.

But act fast if you want to CE mark to the IVDD. The IVDR date of application is nearing: 26 May 2022

Important Caveats

• The device must already have CE marking under the IVDD before the IVDR date of application. This includes having signed the Declaration of Conformity and having registered the device with the relevant competent authority(ies) prior to 26 May 2022.
• No significant changes to the device design or intended purpose can be made to the device after the IVDR date of application.
• Some elements of the IVDR will still apply to these IVDD CE marked devices, including vigilance, post-market surveillance, market surveillance and registration of economic operators and devices.

Devices Not Eligible for the IVDR Progressive Rollout

• Any devices newly introduced to the European market on or after 26 May 2022 must comply with the IVDR.
• Devices classified as Class A non-sterile under the IVDR. The IVDR comes into force for these devices on its date of application, even if it was previously CE marked under the IVDD. Class A non-sterile devices are self-certified under both the IVDR and the IVDD. Manufacturers of Class A non-sterile devices must recompile their technical documentation to comply with the IVDR and re-register the devices with the applicable competent authority(ies).