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