The new EU Medical Device Regulation (MDR) was officially published on 5 May 2017 and entered into force 20 days later, on 25 May 2017. After a three-year transition period, i.e. on 26 May 2020, the MDR will replace the current Medical Device Directive (93/42/EEC) and the Active Implantable Medical Device Directive (90/385/EEC). The MDR introduces a huge amount of changes to the way medical devices are regulated, approved and monitored in the European Union. Giovanni Di Rienzo reviews these changes and their potential impact on novel cardiovascular devices
First of all, the scope of the regulation has been extended to products that do not have a medical intended purpose—such as coloured contact lenses, devices for liposuction and many others.
The rules for classification of devices (class I–class III), based on risk, have been modified and extended causing some devices to fall into a higher risk class. Of particular significance for the cardiovascular field is the fact that all devices intended to be used in contact with the central circulatory system or the heart will fall in the highest risk category (class III), regardless of their duration of contact and whether they are very simple single-use products (e.g. cardiopulmonary cannulae, heart valve sizers, etc.) or novel cardiovascular implants (e.g. bioresorbable scaffolds, transcatheter heart valves, etc.).
The new regulation also introduces more rigorous requirements for clinical evidence. Based on the current understanding and interpretation of the regulation, clinical safety, performance and benefit will have to be systematically reviewed, analysed and documented in a Clinical Evaluation Report, regardless of the classification of the device. For high risk (class III) and implantable devices (class IIa and IIb) the demonstration of compliance with the general safety and performance requirements will have to be based on clinical data generated through a clinical investigation following good clinical practice methodologies. In some rare cases and where sufficient clinical data are already available, a justification for not conducting a clinical investigation may be possible.
Clinical safety and performance will have to be monitored in the post-market phase following a plan to reconfirm throughout the entire lifetime of the device its safety and performance and to identify unexpected risks that could not be identified in the pre-market phase. This will have to be done by pro-active post-market surveillance and rigorous post-market clinical follow-up.
Very significant are also the requirements in terms of reporting. Manufacturers will have to generate and update several reports to reconfirm over the time that their devices continue to be safe and perform as intended in light of the generally acknowledged “state of the art” and that the risks continue to be overweighed by the benefits associated with the use.
One of those newly required reports, the Summary of Safety and Clinical Performance (SSCP), will be publicly available for the final users and for the patients. The SSCP is required for high risk (class III) and implantable devices (class IIa and IIb) only. It will include detailed information on the device and its use, on the clinical data available including those from post-market clinical follow-up, on the possible risks and the possible therapeutic alternatives.
In order to obtain the CE mark under the new legislative framework, class III implantable devices (e.g. heart valves, coronary stents, neurovascular implants, etc.) and certain class IIb active devices (such as drug delivery pumps) will have to undergo the assessment of an “expert panel” nominated by the EU Commission. This panel will scrutinise the clinical assessment of the Notified Body together with documents such as the “Clinical Evaluation Report” and the “Post-Market Clinical Follow Up” plan and will provide a scientific opinion as to the suitability of those.
One key aspect that needs to be pointed out is the fact that the new regulation does not include any “grandfathering” provisions. All devices, including those currently approved and available on the market, will have to be fully reassessed and certified in accordance with the new requirements as if they had never been on the market.
The certification of all the currently approved devices will have to be completed in a very short time frame, between the second half of 2019 and May 2024, but probably with a significant peak in the period 2020–2022. And this will have to be completed by a limited number of Notified Bodies, those that will have managed to obtain a designation under the new regulation.
Notified Bodies are responsible for conformity assessment and approval of devices and are designated by the EU member states and the EU commission. Under the MDR, the requirements applied to Notified Bodies are significantly increased, particularly in terms of resources, competence and expertise. Therefore, it is expected that the number of Notified Bodies (currently 59 for medical devices; 14 for active implantable medical devices; and 22 for in-vitro diagnostic devices) will be significantly reduced.
Given the extent of the changes (and those described above are just a very limited selection), the extremely short transition period and the probable limited availability of Notified Bodies, recertification of existing devices under the MDR might result to be a stressful, costly and lengthy process. As a consequence of that, it is expected, that a large number of manufacturers (especially SMEs) will rationalize their portfolio focusing on a limited number of devices.
Approval of new devices, especially if high risk (class III and implantable), will be more demanding. Higher expectations in terms of clinical investigation data and additional requirements such as the “expert panel” consultation will, no doubt, increase the approval time and the cost of placing a device on the market.
Guidance on the interpretation of the new regulation is still needed to fully understand the details and to assess the real impact. However, the expected consequence of the increased regulatory burden might well be that the EU will no longer be attractive as a first port of call for new technologies. A significant shift is already perceivable in the field as more and more manufacturers are planning product launches in the USA first, followed, only later, by the EU.
The medical devices world is getting ready to face the biggest change seen in two decades in EU. The wise choice to navigate through this challenging time is to start planning and preparation as early as possible; and starting today might not be early enough. Wait-and-see is not an option.
Giovanni Di Rienzo is the global director of the Cardiovascular Focus Team at TÜV SÜD Product Service (Fareham, UK). He spoke about this topic at EuroPCR (22–25 May, Paris, France).