Currently, all medical devices must comply with the Medical Device Directive (MDD) or the Active Implantable Medical Device Directive (AIMDD). However, by 2020, this will change and new medical device products distributed within Europe must comply with the new European Medical Device Regulation (MDR).
Legacy devices, currently manufactured and marketed/CE marked under existing directives, will be expected to meet the new requirements set out in the MDR. However, for devices CE marked under the current directives utilizing a Notified Body there will be an additional transition time of up to four years after full application of the new regulation, subject to certain conditions being satisfied. It is likely that any design changes to legacy devices and pressure from market forces could reduce the practicality of this additional transition period for devices already CE marked under the MDD/AIMD.
Under the new MDR, it is expected that approximately 90% of devices are likely to remain in the same classification. However, even those that are not reclassified may require the generation of additional supporting technical documentation and creation of new labelling, both of which ma need to reviewed by a Notified Body designated under the new regulations.
Even though only about 10% of devices will need to be reclassified, there are significant areas of product up-classification, especially within the orthopaedic space. Many orthopaedic implants that were not previously up-classified under a preceding modification to the MDD, will be up-classified from class IIb to class III devices including many spinal contacting implants.
Some medical devices intended to deliver medicinal products by inhalation will also be re-classified from IIa to IIb and in addition, the new MDR will also introduce specific requirements addressing software classification. Active therapeutic devices including closed loop systems or automated external defibrillators will also now be re-classified as class III.
Furthermore, under the new MDR, devices incorporating nanomaterial will now range from class I to class III depending on the potential for exposure.
A challenging environment for manufacturers
Time is one of the most challenging hurdles for manufacturers. The industry still has a lot to do over the next two years to ensure compliance. In the US, products are clearly classified, however, in the EU it is the manufacturers’ responsibility to review the published classification rules and determine whether there is any impact on their devices. Manufacturers will need to undertake a full review of their currently EU marketed devices to determine compliance gaps against the new MDR including classification, technical documentation, labelling and general safety and performance requirements (including supporting clinical evidence) and take action on the results in enough time to ensure a smooth transition to compliance with the new regulations.
The cost versus return on investment (ROI) is another key consideration for manufacturers. Careful analysis will be needed to determine whether the potential ROI exceeds the cost of compliance, particularly for the lower turnover, older generation, legacy devices. Many manufacturers are likely to have more modern versions of products that may offer better return and more than likely are considered to be superior to the older devices.
Another challenge is the readiness of notified bodies. They are required to be authorised to conduct conformity assessments under the MDR but it is estimated to that no notified bodies will designated under the MDR before Q1 2019 As a result, there are concerns over whether notified bodies will have sufficient capacity to manage timely reviews of all devices within the compressed transition period. Consequently, bottlenecks and longer wait times could be a considerable issue during the transition to CE Marking under the MDR.
In addition, products that are up-classified may require a more thorough notified body review so affected companies should prepare for the additional complexities, perhaps rounds of questions and supporting resource requirements. The transition will be a period of learning and discovery for all stakeholders, and it is important for notified bodies, manufacturers and competent authorities to work collaboratively to manage the conformity assessment of all devices with consistent expectations established on interpretative issues, but particularly, reclassified ones.
What about clinical evidence?
Another of the major challenges that manufacturers face is the potential need for additional clinical data. This can be time consuming and costly. Furthermore, all technical documentation needs to be kept up to date and most labelling will need to be reviewed and updated to maintain compliance. As this can result in significant time pressure on organisations, it must be factored into daily operations to minimise the impact on productivity.
The new MDR is much more prescriptive in defining the acceptable levels of clinical evidence, including sufficient clinical data and clinical evaluation. It specifically considers how each device achieves the clinical benefit claimed by the manufacturer and although this is generally aligned with current expectations, many legacy devices may have some shortcomings in this area.
The new regulation will require much more scrutiny of this evidence by notified bodies and for class III devices, including many implantable devices. A detailed review of the technical documentation may also be required by the notified body. The clinical evaluation process must demonstrate that the new device, subject to clinical evaluation for the intended purpose, is equivalent to the legacy device to which the data relates, and the data must adequately demonstrate compliance with the relevant safety and performance parameters.
Easing the transition
Preparing for compliance is a multi-stage process and early preparation is essential.
- Firstly, it is recommended to recognize areas of weakness that need to be addressed early on. One way manufacturers could achieve this is by conducting a gap analysis and compiling compliance data and technical documentation for a selection of products. This will involve examining the requirements of the MDR and anticipating the interpretation/expectation of the notified body. Investing time up front to check and calibrate expectations will make implementation across the wider legacy product portfolio more effective.
- Secondly, developing a timetable/project plan for implementation will ensure that manufacturers remain on track. It will be necessary to account for the time taken to identify affected products, update technical documentation and review all labeling requirements.
Manufacturers should have already started preparing for the transition to the MDR but with the deadline only two years away, there is still a lot to do to ensure that devices will be in full compliance. Effective and efficient planning and regular communication with notified bodies should help manufacturers navigate the uncertain regulatory environment. Missteps or delays could have significant negative impacts on device companies, healthcare providers and the patients who rely on these life-saving and life-sustaining products.