The proposed Medical Device Regulation 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 EU MDR will be significantly expanded to include devices that may not have a medical intended purpose, such as colored 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.
- Identification of “qualified person” - Device manufacturers will be required to identify at least one person within their organization who is ultimately responsible for all aspects of compliance with the requirements of the new MDR. The organization must document the specific qualifications of this individual relative to the required tasks.
- Implementation of unique device identification - The proposed EU 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.
- Reclassification of devices according to risk, contact duration and invasiveness. The EU MDR will likely require device manufacturers to review the updated classification rules and update their technical documentation accordingly by considering the fact that class III and implantable devices will have higher clinical requirements and a regular scrutiny process.
- More rigorous clinical evidence for class III and implantable medical devices. Manufacturers will need to conduct clinical investigations in case they do not have sufficient clinical evidence to support the claims done on both safety and performance of a dedicated 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.
- Systematic clinical evaluation of Class IIa and Class IIb medical devices. Manufacturer will need to re-prepare their clinical evaluation by considering the new wording of the regulation on when an equivalence approach and under which circumstances it is possible to justify not conducting a clinical investigation.
- No "grandfathering" provisions – Under the MDR, all currently approved devices must be recertified in accordance with the new requirements. Exemptions are under negotiation right now.
Additional changes to the EU Medical Device Regulation 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 EU 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 EU Medical Device Regulation, 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 EU 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.