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The Medical Device Directives are changing


The Medical Device Directives will soon be replaced by the Medical Device Regulation - will you be ready?


When are the Medical Device Directives changing?


Both regulations are in the final stages of the legislative procedure and are expected to be finalized sometime in 2016, allowing them to come into effect by the end of 2016, or early 2017.










Key changes


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.


Conclusion

In conclusion, the MDR will bring about very significant changes that will affect all devices from manufacturers currently on the European market. Not only will the administrative burden increase substantially as a result of registration requirements and UDI, but manufacturers will also have to revisit all technical files and the quality system for all their devices currently on the market. They may need to generate additional clinical evidence for devices currently on the market in order to be able to transition them to the new regime implemented by the MDR.


Consequently, manufacturers must take a pro-active approach to the new regulation, plan for the transition of existing devices in a timely and detailed way, and allocate resources for this effort. Since their notified body may not be around anymore to re-certify devices on the market or new devices, manufacturers must plan for a possible transition from their current notified body.


For the new devices manufacturers must decide whether they want to comply with the new rules already during the transitional period or when that period expires. Again, a pro-active approach is needed as the MDR will require more clinical evidence, especially for higher risk devices, which will take time to generate.