The announcement of the one-year delay to the European Union’s Medical Device Regulation (MDR) date of application (new date: May 26, 2021) is shaping up to be a major sense of relief for medical device manufacturers around the world. While we all deal with the enormous impacts of the COVID-19 pandemic, manufacturers are shifting gears with the imminent decision to delay MDR until 2021. What the delay means to all and different classes of medical devices varies, but it provides them all with something they needed -- more time for the first steps of the transition.
For all manufacturers, the delay means more time to implement the requirements in the MDR under Article 120(3) for the implementation of postmarket surveillance (PMS), vigilance, and registration requirements. Most manufacturers should already have procedures in place to address these requirements, however for those that did not or did not yet finalize resources or other implementation measures to meet these requirements, there is more time. Manufacturers who have already made the investment in resources to implement these requirements will have an opportunity to review and refine the implementation measures.
For Class I medical devices, the manufacturer is required to be fully compliant to the requirements of the MDR by the date of the application. As a result of this delay, these manufacturers have an additional year to demonstrate and declare compliance to the MDR. The impact of this delay is relatively small because most Class I medical device manufacturers should really have had all the technical documentation, testing and quality management system requirements in place by now, one month prior to May 26, 2020. However, in practice I believe that most Class I medical device manufacturers are not yet in full compliance and this one-year delay will be a great help to these manufacturers to get in compliance.
Most Class IIa, IIb and III device manufacturers have already obtained early recertification of their existing Medical Device Directive (MDD) and Active Implantable Medical Devices Directive (AIMD) certificates to allow the devices certified under these certificates to continue to be placed on the market without significant changes until the date of expiration of the MDD/AIMD certificates. This delay does not change the expiration dates of these certificates and the timelines for implementation of the MDR in order to continue to place these products on the market has not changed.
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Relief is high for a small group of manufacturers who were not able to renew their MDD/AIMD certificates in time, due to existing lists of deficiencies, potentially a suspension or unfortunate circumstance where lockdown measures made it difficult to provide the requested improvements in time.
However, there has been much speculation that there may be an opportunity to obtain CE mark certification under the MDD or AIMD for new devices or submit changes under the MDD or AIMD between now and May 26, 2021. Before this delay, Notified Bodies (NBs) communicated to their clients a final date of submission for new devices or changes to existing devices under the MDD and AIMD. And, in fact, a number of manufacturers had submissions in process, but because they did not yet receive a recommendation for certification or change approval, they received notification that they will have to resubmit the application under the MDR. From a device manufacturer's perspective, this delay clearly offers the opportunity to resume these reviews and for new submissions. The first NBs have indicated to allow selected submission throughout the summer.
What manufacturers have to remember is that this is a huge change for the NBs also. The NBs have planned their resources based upon a DOA of May 26, 2020. This means that for all NBs, whether they are not yet designated, were not planning on obtaining designation to the MDR, in the process of becoming designated, or already designated to the MDR -- they may no longer have the resources or capacity available to perform these reviews under MDD and AIMD. As a result, this delay may not present this opportunity to manufacturers. Manufacturers will have to discuss this with their NB to determine if these submissions will be permitted.
It may be valuable, as a result of this delay, for manufacturers to again review their product obsolescence plan, as it may be that some products that were going to be removed from the market on May 26, 2020, may not need to be removed yet (such as Class I devices).
The one-year delay will also significantly reduce the number of MDR applications for CE certification in 2020. The delay will likely mean that there will be an increase in the overall number of applications to the MDR 2021 through 2024. This increase will put a greater strain on NB capacity. NBs have made assessments of the required resources for the MDR, and, as a result of this delay, the number of required resources may not be enough. I guess the one-year delay gives these NBs time to address the impact to their resources, however, it is reasonable for manufacturers to prepare for even longer timelines for all NB activities between 2021 and 2024.
As of today, there are 14 Notified Bodies designated to the MDR. This count includes the doubling of BSI NL and BSI UK. There are still a number of NBs that have applied for the MDR and have not yet received designation. The pace of additional notified body designations will likely be impacted by the coronavirus.
In order to obtain designation, the NB designation process requires a joint audit. At this time, joint audits are not being conducted as a result travel and group formation bans due to the coronavirus. Until travel bans are lifted or unless it is permitted for the joint audits to be conducted remotely, designation of any NBs that still require a joint audit will be delayed.
In addition, quite a few of the people in government involved in the designation process have a role in and have prioritized national coronavirus management. As a result, the resources that would normally be focused on review of NB applications, audits and corrective actions are now focused on national crisis management. It is therefore a reasonable assumption that the NB designation process will be significantly delayed.
So, in summary, the delay brings us all short-term relief as we have more time to prepare initial steps toward MDR compliance. But as the final deadlines are not shifting away from May 25, 2024, or the expiration date indicated on the MDD/AIMD certificate, ultimately, the work that needs to be done by designating authorities, NBs and the manufacturers will be compressed in time. And that will put extra pressure on already tight resources. Time to think about effective use of your downtime during the MDR delay and the coronavirus lockdowns!
For more information on COVID-19, visit the QServe Group at https://www.qservegroup.com/eu/en/knowledge-center/qserve-covid-19-bews-and-updates.For more information about QServe Group's services, visit https://www.qservegroup.com/.
Gert W. Bos, PhD, Fraps
Executive Director & Partner, Qserve Group
Gert has 26 years of experience in life sciences (devices and pharma), in university, industry, 4 Notified Bodies, and in strategic regulatory and business consulting. He is a president-elect and member of the Board of Directors of RAPS, founding member of the Board of Directors of RAPS Europe and a founding board member of the Dutch RAPS Chapter. Gert provides strategic consulting on complex regulatory matters, on interactions with Notified Bodies and EU pharma agencies, on suspensions and cancellations of certificates, field safety corrective actions and more. He is supporting due diligence processes from RA/QA perspective. And finally, he provides insightful dedicated in-house training on regulatory matters, including EU-MDR and EU-IVDR.
Before joining Qserve, he served 7 years as Head of Regulatory and Clinical Affairs of BSI (NB0086) and Head of Notified Body at BSI-Germany (NB0535), and a similar time as head of the certification team at KEMA (now Dekra, NB0344).He has served as President of the Notified Body Association TEAM-NB, and as Chair and Vice-Chair of the Medical Notified Body forum NB-Med in Brussels for over a decade. In these roles, he represented Notified Bodies in many EU Commission meetings and workgroups and represented Notified Bodies in the process of drafting and finalizing the EU-MDR.