With the guiding aim of bringing about a “robust, transparent, predictable and sustainable regulatory framework for medical devices which ensures a very high level of safety and health whilst supporting innovation”, the new European Medical Device Regulation (MDR) was finally published in the Official Journal of the European Union on May 5, 2017. This new regulation replaces both the previous Medical Device Directive and the Active Implantable Medical Device Directive (90/385/EEC).
Attend the virtual conference: The New EU Medical Device & IVD Regulations | August 29–30, 2017 | Keynote speaker: Melissa Torres, associate director for international affairs, CDRH | Learn moreThe new MDR will bring about a number of changes that manufacturers need to be thinking about immediately, if they haven’t already begun. It’s critical that they reach full compliance within the next three years and to do so, inroads must be made now. For example, manufacturers need to pay close attention to the MDR Classification rules in Annex VIII to determine whether new conformity assessment routes are now applicable to their product portfolio. If so, they need to get in touch with their Notified Body to take steps to make sure that all requirements are met in the specific time frame.
Also, focusing on specific products, when it comes to the reprocessing of single-use devices, the MDR states that reprocessing and further use of single-devices should only take place where permitted by national law, while complying with requirements in the MDR Article 17. In fact, reprocessors are deemed on par with manufacturers and must therefore ensure a level of safety and performance equal to that of the corresponding initial single-use device. Reprocessors therefore need to analyze their position as soon as possible and make amends if any are required.
Market access of legacy products is another area that is more strictly regulated and all products will have to be CE marked under the new regulation 2017/745. In order to ensure all products meet this requirement, a comprehensive plan needs to be put in place early. The MDR is similarly more stringent on the required content of technical documentation, particularly as there are more detailed requirements for quality management systems. Similarly, medical device manufacturers will be required to collect post-market clinical data as part of their on-going assessment of looming safety risks. Therefore, it is important that they review their procedures for post-market surveillance and ensure that the responsibility for the provision of this additional data and associated support is established clearly.
Transparency has been one of the key principles within the MDR and it is up to manufacturers to keep close watch on the European Data Bank on Medical Devices (EUDAMED) and to be ready to notify them of all products once it has been implemented. In light of this, increased focus is placed on labeling and the supply chain with each manufacturer responsible for appointing a person responsible for regulatory compliance (PRRC). There are also more prescriptive requirements placed on EU Authorised Representatives (EUAR).
Labeling requirements are much more prescriptive: Any information that is supplied by the manufacturer must be made available and kept up to date on the manufacturer’s website. Manufacturers should carefully review their current product labeling and precautionary statements. The new MDR will require all devices to be fully traceable through a Unique Device Identification (UDI) system, which means detailed planning for UDI implementation in the EU will be required.
Finally, it will be up to the manufacturer to guarantee that they are able to provide sufficient coverage for any potential liability. It is advisable that manufacturers rapidly seek legal counsel to assist with reviewing all product liability provisions.
With the new MDR touching on so many critical processes it is imperative that manufactures are pragmatic and proactive, reviewing processes and ensuring that a plan is in place. Targeting the new changes in an isolated and siloed manner could cause problems later down the road, so manufacturers should look to appoint team members from various functions of the business to take responsibility and see processes through. But making sure products are in compliance with new MDR requirements can also bring unexpected benefits, as it is a good opportunity for manufacturers to audit their product portfolio and eliminate any marginal and unnecessary products.
The resources and time that will be required for implementing the new MDR should not be underestimated, and it is absolutely fundamental that manufacturers build a robust road map to implementation and use reliable and efficient project managers to drive the change. Manufacturers that immediately set about educating top management to the new MDR and enlisting their support will be well placed to face the changes with a well-thought out plan putting them on track for success.