Author: Suzanne Broussard
The global COVID-19 pandemic prompted the 1-year extension of the Medical Device Regulation (MDR) 2017-745 date of application. The delay is creating a changing and challenging dynamic landscape for device manufacturers and notified bodies (NBs).
As the seriousness of the COVID-19 pandemic emerged in March, the European Commission recommended a 1-year extension to the MDR date of applicability, the Parliament and Council then acted quickly with an almost unanimous decision supporting the delay, and the extension was ultimately accepted by the member states and published in the Official Journal on 23 April 2020.
The ongoing pandemic has created a high demand for resources such as surgical masks, medical gloves, and other medical and personnel protective equipment — keep these supplies flowing is a top priority to protect both patients and healthcare workers. The delay of the MDR date of applicability was implemented to ensure that hospitals and healthcare facilities have a continued supply of devices during the critical times of the pandemic.
It is important moving forward to understand that the delay was not implemented to provide manufacturers with more time to become compliant with MDR, and the European Commission expects that manufactures are continuing to work to comply with the newest regulation. However, the delay presents both opportunities and challenges for manufacturers.
Of course, the biggest benefit of the delay is time. Time that is in short supply for manufacturers and NB dealing with the ongoing changes to device regulations. The extra time may most benefit manufacturers of class I devices that were short on time to take advantage of the grace period provided under the second corrigendum of MDR 2017/45. Manufacturers in the following positions have the most to gain by the 1-year delay.
- Class I Devices with Significant Changes: The Second Corrigendum of MDR 2017/745 provides a grace period for some self-declared class I devices under MDD. The grace period essentially means that qualifying class I devices do not need to be certified to the new MDR regulation but instead can utilize the MDD Declaration of Conformity until the 25th of May 2024. However, the class I device cannot have significant changes. The additional time may allow manufacturers of class I devices that are likely to be up classified under MDR and have not already done so the time to make the necessary revisions and complete an MDD CE certification.
- Renewal of MDD Certification: Device manufactures that needed a little more time to renew their Medical Device Directive (MDD) or Active Implantable Medical Devices Directive 90/385/EEC (AIMDD) CE-certification now have some breathing room. The impact on manufacturers that may have just missed the original deadline for the MDR date of application is immense since devices with a current certification under MDD are allowed to utilize the transition period covered in MDR 2017/745 giving 3 more years to become fully complaint in 26 May 2024.
- Compliance with Post-Market Surveillance, Market Surveillance, Vigilance, and Registration of Economic Operators: This is an important area for manufacturers since they must still set-up and maintain a number of systems for the application of MDR. Manufacturers need to develop and implement quality management systems and procedures for risk management, clinical evaluation, and post-marketing surveillance (PMS) / post-market clinical-follow-up (PMCF). These processes take time to develop and improve. Likewise, logistic issues like Economic Operator requirements and contracts can be evaluated.
- Notified Bodies: The European Commission and EU Member States will have an additional year to accredit NBs under the MDR. The number of NBs is still far fewer than the original projections, and these NBs are overextended working with manufacturers that are scrambling under these tight deadlines to obtain an early MDD to take advantage of MDR’s transitional provisions.
The delay is also creating several challenges for both manufacturers and NBs.
Medtech Insight hosted an MDR discussion panel consisting of 3 outspoken and renowned experts on the regulations of medical devices in the European Union: Bassil Akra of QUNIQUE consultancy (formally of TÜV-SÜD notified body), Gert Bos of Qserve consultancy, and Erik Vollebregt of Axon Lawyers.1
The take home message from this highly respected panel was simple.
A year is not an extra year.
Several important considerations were raised in the panel discussion that device manufacturers should take into consideration.
- NBs are working very hard to get class I devices that are eligible into the grace period provided by the Second Compendium published as recently as 25 November 2019. In order to take advantage of the grace period, the current MDD certification has to be renewed by the date of MDR application (now the extended 26 May 2021 date). This is a real hurdle because many class I device manufacturers have not used NBs in the past, and therefore many of these manufacturers really need the delay to adequately prepare.
- The large medical device manufacturers are accustomed to working in this regulatory space, but many of the smaller distributors and third-party logistics (3PL) companies still have a fair amount of confusion and it takes time for all the news to trickle through the pipeline.
- Only a handful of NBs (2) are currently focused on new MDRs, most of the 14 NBs are focused on renewals and may not have enough time or resources to transition from MDD to MDRs.
- There has been a flurry of guidance documents published in May, giving manufacturers little time to react to the interpretations. NBs and manufacturers are hoping for a more relaxed interpretation of the guidance documents, but there is no guarantee the member states will have consistent implementation.
The panelists agree there is much to do moving forward.
The additional challenges of social distancing and the general global lockdown brought on by the pandemic will impact the ability of NBs and manufacturers moving forward. A recent ruling allowing NBs to conduct virtual audits for MDD renewal was critical. However, delays will make the new extension seem like much less than a year.
1. EU MDR Panel Discussion: Why An Extra Year Is Not Really A Delay For The MDR – How To Survive Changing And Confusing Times. Medtech Insight https://medtech.pharmaintelligence.informa.com/MT142211/EU-MDR-Panel-Discus
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