On 5th May 2017 the Regulations were formally published in the Official Journal of the European Union (OJ). The legal texts enter into force 20 days after publication in the OJ, i.e. 26th May 2017. To allow time for transition to the new requirements the Regulations will become fully applicable over a period of 3 years for the MDR and 5 years for the IVDR. During this transitional period there will be a staggered application of the new requirements. From 6 months after the enter into force of the new Regulations, ie 26th November 2017, notified bodies can submit applications to the competent authority be designated under the new Regulations. This designation process is expected to take 18 months after which notified bodies can begin to certify devices to 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 2020 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.
The transition period envisaged is staggered so this means that some provisions become fully applicable and legally binding earlier within the 3-5 year transition periods envisaged. For instance, the requirements for designation of notified bodies for medical devices become applicable 6 months after entry into force, which means based on the above timeline that they will be binding from November 2017. Notified bodies when designated to the new legislation, may issue certificates to the new Regulations before 2020 if the manufacturer requests them to do so and the notified body is satisfied that the devices comply with the new requirements.
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 2020 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.