80% of IVDs devices that did not need to involve a notified body under the previous Directive (IVDD) will need to newly obtain a CE Certificate under the IVD Regulation (IVDR) to be placed on the EU market. Very few devices remain at the lowest risk class (Class A) and do not need to involve a notified body under the IVDR.
For this reason, the EU authorities have granted legacy device manufacturers more time to obtain IVDR CE Certificates (legacy or grace period). Until the end of the grace period deadline that depends on the risk class of IVD, these devices can be placed on the market, meeting legacy requirements.
Here’s the way to meet the legacy requirements:
1. Assess the legacy status of your device: If your IVD has a CE Certificate under the In Vitro Diagnostic Directive (IVDD) or is up-classified under IVDR is considered a legacy device. Legacy devices that fall among the following IVDR risk classes will require an IVDR CE Certificate by the end of the legacy period: Class A sterile, Class B, Class C and Class D. I
2. Continue to comply with the IVDD: Legacy devices must still comply with the In Vitro Diagnostic Directive. Do not forget about the extra obligations listed below!
3. Comply with legacy requirements: Manufacturers also need to meet legacy requirements under IVDR, namely a post-market surveillance system (PMS Plan & Report), vigilance, and registration of economic operators and devices, among others. It remains mandatory for non-EU based manufacturers to appoint a European Authorised Representative!
4. Place your product on the market: Once compliant with legacy requirements, your device will be allowed to be placed on the EU market until:
- 26 May 2025 for Class D devices;
- 26 May 2026 for Class C devices;
- 26 May 2027 for Class B devices and Class A sterile devices;
In the case of the Great Britain market, manufacturers need to comply with extra UK requirements, such as appointing a UK Responsible Person and registration.
It is essential for manufacturers to use this legacy period and apply for IVDR CE Certification to a Notified Body at an early stage. In both cases, Obelis can assist you. On the one hand, Obelis will ensure your device’s documentation complies with IVDR legacy requirements, and the product can be placed on the market without issues. Obelis can also help you find a Notified Body designated under the IVDR that suits you.