Top 10 Challenges of the New MDR

The new European Medical Device Regulation (MDR) has long been exercising compliance professional’s minds within the medical devices industry. Finally, after a prolonged process, agreement has been reached and the new MDR was 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).
 
The guiding aim of the new MDR is to bring about a robust, transparent, predictable, and sustainable regulatory framework for medical devices that ensures a very high level of safety within the healthcare industry while continuing to support innovation. These changes will inevitably be beneficial; however, until the new MDR is completely rolled-out, a few bumps in the road are to be expected. In fact, there is a three-year transition period following the publication of the MDR, which means it will only be fully in force by 2020. Regardless, it is critical that manufacturers take action now in order to gain stakeholder buy-in and prepare their businesses to implement the required changes to their business processes.
 
Notified Bodies (NB) too will be affected by the new MDR and will themselves need to seek designation under the MDR in the next few months. There have been a number of notable safety issues in the past that have had a significant impact on the development of the new MDR, which means that NBs are themselves under considerable pressure from their respective Competent Authorities to heighten security of their medical device manufacturers. NBs are already facing significant capacity issues with numbers dwindling in Europe, and the more stringent requirements set out by the MDR are very likely to escalate this existing issue.
 
NBs are in a particularly difficult Catch-22 position as there has already been a significant decrease in their numbers, but an increased demand on their services is to be expected as the MDR rolls into force. Also, importantly, once an NB is re-designated under the new MDR, they will no longer be able to issue CE marks under the previous Directive, even during the transition period. Not only are manufacturers going to have to factor in long periods of time to ensure their NB has the capacity to help them, but they are going to have to implement procedures to deal with unannounced inspections, which are set to take place at least once every five years under the new MDR.
 
In order to try to encapsulate the main changes brought about by the new MDR and how these can be addressed, the following list of the top ten hurdles that manufacturers will need to watch out for as the new MDR transitions into effect has been assembled.
 
1. Reclassification
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 NB to take steps to make sure that all requirements are met in the specific time frame.
 
2. Market Access of Legacy Products
All products will have to be CE marked under the new regulation 2017/745. A comprehensive plan needs to be put in place to ensure that all products that are placed on the market are compliant with the new MDR. (This should also include products that are currently still in the development phase.)
 
3. Reprocessing of Single Use Devices
A very controversial topic throughout the MDR deliberations, which now specifies 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.
 
4. Technical Documentation
The MDR is going to be far more prescriptive about the required content of technical documentation, particularly as there are more detailed requirements for quality management systems. Manufacturers will have to ensure that they keep an eye out for the publication on the new common specifications.
 
5. Clinical Evaluation
The new MDR is much more specific about the need for clinical evidence proportionate with the risk associated with a given device. Following this, manufacturers may be required to obtain additional data from clinical studies—manufacturers should look to review all their clinical evaluation reports (CER) if not reviewed within the last one to two years and guarantee that CERs include post market surveillance (PMS) data.
 
6. Vigilance and Post Market Surveillance
Under the new regulation, 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 PMS and ensure that the responsibility for the provision of this additional data and associated support is established clearly.
 
7. Mandatory Product Liability Insurance
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.
 
8. Transparency
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.
 
9. Labeling and the Supply Chain
It will be the responsibility of each manufacturer to appoint a person responsible for regulatory compliance (PRRC). There are also more prescriptive requirements placed on EU Authorized 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 manufacturers’ website. Manufacturers should carefully review their current product labeling and precautionary statements.
 
10. UDI
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. Even though the details of the EU UDI system have not been finalized, it is thought it will not be too different to current systems in place in the United States.
 
Conclusion
With the new MDR touching on so many critical processes, it is imperative that manufactures are proactive and implement a pragmatic strategy to ensure compliance now. Targeting the new changes in an isolated and siloed manner will not work; rather, manufacturers should look to appoint team members from various functions of the business to take responsibility over specific processes and adaptions. But ensuring 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 who engage top management support and implement a proactive approach to deal with the new changes will be on the right track to success and the EU market will be populated only by safe medical devices that perform optimally.