The proposed MDR differs in several important ways from the EU’s current directives for medical devices and active implantable medical devices. The most significant changes in the proposed regulation include:
- Product scope expansion - The definition of medical devices and active implantable medical devices covered under the MDR will be significantly expanded to include devices that may not have a medical intended purpose, such as coloured contact lenses and cosmetic implant devices and materials. Also expected to be included in the scope of the regulation are devices designed for the purpose of “prediction” of a disease or other health condition.
- More stringent clinical evidence - The MDR will require device manufacturers to conduct clinical performance studies and provide evidence of safety and performance proportionate with the risk associated with a given device. Device manufacturers will also be required to collect and retain post-market clinical data as part of the ongoing assessment of potential safety risks.
- Identification of “qualified person” - Device manufacturers will be required to identify at least one person within their organisation who is ultimately responsible for all aspects of compliance with the requirements of the new MDR. The organisation must document the specific qualifications of this individual relative to the required tasks.
- Implementation of unique device identification - The proposed MDR mandates the use of unique device identification (UDI) mechanisms. This requirement is expected to increase the ability of manufacturers and Authorities to trace specific devices through the supply chain, and to facilitate the prompt and efficient recall of medical devices that have been found to present a safety risk. In addition, the European Databank on Medical Devices (Eudamed) is expected to be expanded to provide more efficient access to information on approved medical devices.
- Rigorous post-market oversight - The MDR will grant Notified Bodies increased post-market surveillance authority. Unannounced audits, along with product sample checks and product testing will strengthen the EU’s enforcement regime and help to reduce risks from unsafe devices. Annual safety and performance reporting by device manufacturers will also be required in many cases.
- Specifications - The MDR plans to allow the EU Commission or expert panels to be defined to publish Common Specifications which shall then be taken into account by manufacturers as well as Notified Bodies. These Common Specifications shall exist in parallel to the Harmonized Standards and the State of the Art.
At present, the final approval of the MDR is expected sometime in 2016, but this timeframe is dependent upon the successful conclusion of consultations between the EU Commission, the EU Parliament and the EU Council. Once approved, it is expected that manufacturers of currently approved medical devices will have a transition time of three years from publication to meet the requirements of the MDR.
It is important to note that, as an EU regulation, the MDR will have the force of law throughout the EU when it comes into effect. While this will eliminate country-by-country interpretations of the requirements permitted under current directives, it might also speed up the implementation of the MDR’s requirements across the EU.
Additional changes to the MDR are still possible at this stage of the legislative procedure, and the actual terms of the proposed regulation are not final until the publication of the MDR in the Official Journal of the European Union. However, the complex development process for most types of medical devices, combined with the need to address new regulatory requirements and obtain Notified Body approval, is likely to make the transition a complicated and time consuming process for most device manufacturers. Further, currently approved devices are not exempt from the requirements of the new regulation and will need to be re-evaluated and re-approved.
Medical device manufacturers are well-advised to stay current on the progress of the MDR through the legislative process, as well as additional changes that may impact them. In addition, since a large number of medical devices will now require Notified Body review and approval, delays in the review and approval process by Notified Body should be expected. Therefore, it is recommended that manufacturers of currently approved devices consult with their respective Notified Body to evaluate potential compliance issues and to develop a plan to address them promptly. Advanced preparation and early action will be key to ensuring a smooth transition to the new requirements.
TÜV SÜD Product Service is closely evaluating the developments related to the MDR, and will provide in the coming months, resources for medical devices manufacturers to help them stay informed about the anticipated changes and prepare for the transition.
As the world’s largest EU Notified Body for all types of medical devices covered by EU directives and regulations, TÜV SÜD Product Service is prepared and working closely with the Authorities to get notification as a Notified Body under the new MDR. Under the new regulations, stricter requirements will be imposed on Notified Bodies and all existing Notified Bodies will have to receive new notification. Therefore, it is essential for manufacturers to have a Notified Body who will retain their status after the new regulations take effect.