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As part of the EU’s Medical Devices Regulation (MDR), the Council of the European Union (EU) has again published a new Corrigendum and a set of corrections. The new corrigendum gives manufacturers of certain Class I devices an additional four years for transition and compliance. This read similar to the first corrigendum, which not only gave a "grace period" to certain higher-risk devices that required notified body review, and certification under the MDR, but also exempted the devices from seeking recertification until 2024.
As per the new corrigendum Class I reusable devices like surgical instruments, endoscopes, and certain software are expected to get an additional four years, i.e. until May 26, 2024, to comply with the MDR. The devices (both released or yet to be released) that are already in full compliance with the MDD may remain in the market until May 26, 2024. The additional time to comply can give manufacturers of Class I medical devices ample time to prepare their technical documentation for the notified body review.
Key Considerations
Though the EC has supported the delay for some Class I devices, it does not indicate that it will support delaying the implementation date of the entire MDR. In that case, manufacturers should consider:
- the exempted Class I devices may have to comply with the MDD
- As the requirements of the MDR apply in place of the corresponding requirements in the MDD, there must be no significant changes in the design and intended purpose of the medical devices
- the requirements of MDR relating to post-market surveillance, market surveillance and vigilance registration of economic operators remain to be applied during the transition
With the compliance deadline fast approaching for transitioning to the EU MDR, many companies are already being due diligent. However, the updates/corrigenda might disrupt or delay their transition process. In such critical times, only a comprehensive understanding of the regulations, timely action, and impeccable implementation is considered beneficial for compliance.
