The EU Regulations entered into force in May 2017 following formal publication in the Official Journal of the European Union (OJ). To allow time for transition to the new requirements, the Regulations will become fully applicable over a transition period. The MDR originally provided for a three-year transition period, however, due to the global outbreak of Covid-19, full application of the MDR has been extended and will be fully applicable on 26 May 2021. Please see the HPRA's MDR Regulatory Timeline for additional details. The IVDR will be fully applicable on 26 May 2022, after a five-year transition period.
During this transitional period, there will be a staggered application of the new requirements. From six months after the entry into force of the new Regulations, i.e. 26 November 2017, notified bodies could submit applications to the competent authority to be designated under the new Regulations. This designation process typically takes between 12-18 months and once designated, notified bodies can begin to certify devices to the new requirements. Notified bodies when designated to the new legislation, may issue certificates to the new Regulations before 2021/2022 if the manufacturer requests them to do so and the notified body is satisfied that the devices comply with the new requirements. During the transitional period, devices can continue to be certified and placed on the market according to the current Directives. This means that the Regulations will not be fully legally binding until 2021 and 2022, respectively.
The new Regulations on medical devices will result in significant improvements and developments of the regulatory system for medical devices and in-vitro diagnostic devices. Nevertheless, the Regulations are highly complex and require a transition period to be implemented fully by manufacturers, notified bodies, regulatory authorities and all of the other operators affected by them.
It is critical that notified bodies, manufacturers and other economic operators relevant to medical devices are aware of the new EU Regulations and the inherent obligations therein. While the two Regulations will not be fully applicable until 2021 and 2022 respectively, there will be a significant lead time required to ensure that procedures, systems, documentation and devices are all developed appropriately to ensure that they comply with the new requirements.