The EU Commission has welcomed the adoption by the EU Parliament for the proposal that has been put forward regarding the extension in the transition periods for certain IVDR’s. The new rules will give more time for manufacturers to transition to the new requirements of the IVDR and aims to mitigate the risk of device shortages without compromising the safety.
The additional time that manufacturers have to be compliant with the IVDR depends on the classification of the device. The higher-class devices have a shorter extension to the transition period, while the lower-class devices have a more elongated transition period. Under the new legislation, manufacturers will be given an extra 2 years and a half to fully comply with the IVDR requirements when compared to the old legislation. The table below shows the differences in the transition periods for each class of device under the old legislation and new legislation.
What are the next steps you may ask. Well, the council will need to formally adopt the amending regulation and it will enter into force on the day of its publication in the Official Journal of the European Union (OJEU).
Under this new legislation, manufacturers are also required to give prior notice if they anticipate a disruption in the supply of certain IVD’s. The information must be provided to the relevant actors such as competent authorities and distributers of healthcare products 6 months in advance.
More information can be found using the following link
