The Delay of EU MDR
The EU MDR Delay – What It Means For Your Medical Devices
With the global COVID-19 pandemic disrupting industries, medical device stakeholders have rapidly diverted efforts from the short-term urgency of ensuring regulatory compliance by May 26, 2020, to provide the immediate delivery of vital medical devices.
Given that the EU Member States, health institutions, economic operators, and other relevant parties will not be equipped to ensure the proper implementation and application of the MDR from May 26, 2020. The one-year postponement to the enforcement of the EU MDR and extension of the validity of the Medical Device Directives (MDD) came into effect on April 20, 2020.
The European Commission stated that given the priority to address the coronavirus crisis and maintain a high level of public health and patient safety protection, it is necessary to defer the application of specific provisions to avoid potential market disruption.
This one-year deferral or ‘grace period’ will bring much-needed respite to an already overburdened medical devices industry that has been unable to focus efforts towards the fast-approaching current date of application of the MDR.
Tell me the Point of Delay. Is it a crucial step?
MEDNET’s delaying of one year’s deadline was critical that the industry concentrates its efforts on responding to COVID-19. The industry and its regulatory authorities were not ready for the MDR even without the covid19 pandemic, and once the pandemic appeared absolutely needed.
This delay was a crucial step. The industry will appreciate the new breathing space the extra 12 months have given. However, it would be illusory if a company shuts its eyes to MDR and continues the current process of MDR despite the delay. NB’s already have primarily agreed to comply with them.
Keys Points to Note
The one-year postponement will not modify the substance of the MDR or impose new obligations on the concerned parties. In light of the disruption due to COVID-19, this postponement primarily aims to provide manufacturers additional opportunities to extend MDD certificates and offer extra time to prepare their Quality Management Systems (QMS) to meet the stricter post-market surveillance requirements. In addition, Medical Device Coordination Groups (MDCG’s), post-market clinical follow-up plans (PMCF), and evaluation report templates have been published to guide manufacturers and notified bodies on clinical evidence needed for medical devices previously CE marked under the MDD and demonstrated equivalence.
It is possible that to address shortages of vitally critical medical devices effectively, specific MDR-related transitional provisions will apply, which will allow national authorities to place particular devices on the market even if the conformity assessment has not yet been performed.
While manufacturers will benefit from the proposed delay to the date of application, manufacturers of devices that remain class I only (i.e., not type Is, Im, or Ir) under the MDR will have an additional year to ensure their self-certificated class I devices meet MDR requirements.
Additionally, Corrigendum 2, proposed in December 2019, stipulates that it will provide a four-year transitional period for specific low-risk medical devices, such as certain software currently classified as Class I, to be moved into a higher-risk class.
I. MDD Certificate Renewal
Notified Bodies designated for MDR work have experienced capacity issues when trying to service all manufacturers’ requests to conduct ‘early’ MDD certificate renewals such that certificates could be issued & audits undertaken by May 25, 2020.
However, due to the global impact of COVID-19, Notified Bodies (NBs) will be significantly strained by their inability to conduct on-site renewal audits and the immediate need to facilitate the supply of medical devices to fight the pandemic. Despite the introduction of remote assessments over the next year, even fewer resources will be available to conduct MDD certificate renewals. Further small reviews will pose challenges for some manufacturers wherein on-site renewal assessments are crucial.
II. Compliance with MDR regarding Article 120, Section 3
With the delay in enforcement of the MDR, manufacturers will now have an additional year before the requirements of Article 120 section 3 regarding Post-Market Surveillance, Market Surveillance, Vigilance, and registration of Economic Operators become mandatory. In addition, this year-long delay will give them the extra time required to understand their existing Economic Operator relationships, ensuring that both logistical issues are resolved, and contractual obligations are set.
Suppose a Class I device requires the involvement of a Notified Body, and the device is on a Declaration of Conformity before May 26, 2021. In that case, it can remain on the market under certain conditions until May 26, 2024. The device is eligible for this extension if it complies with either of the Directives and continues to meet the requirements of the MDD with no significant changes in the design and intended purpose. Class I devices (e.g., sterile or measuring) with a valid certificate from a Notified Body may remain on the market. Some examples of exempted devices are reusable surgical instruments, software that would have been up-classified, substance-based devices (e.g., lubricants), and inhalers.
This delay in MDR enforcement does not impact the In Vitro Diagnostics Regulation (IVDR), which will still be effective from May 26, 2022. However, the Industry group MedTech Europe argued that IVD manufacturers working round the clock to rapidly bring novel coronavirus diagnostics to market need more time to achieve compliance.
Recommendations for Medical Device Manufacturers
Given the current adverse global scenario, many companies will still be behind on their compliance despite the extended timeline and thus will need to use their time wisely.
Start the review process early
It is suggested that manufacturers evaluate their MDR transition plan considering their current MDD certificate expiry dates and consult with their Notified Body for each of their devices to understand if further MDD early renewal audits may be possible.
The European Commission has stated that 20 more NBs shall be designated under the MDR by the end of 2020. While this gives these NBs additional time to achieve MDR designation, capacity will still be an issue, so start early! The benefit for manufacturers depends mainly on how their Notified Body decides to use this additional one-year period.
Collect more data
Considering the increased requirements of the MDR, manufacturers should use this additional time to collect PMCF data and push forward their preparations, beginning with a general review of documentation for the date of application in May 2021.
To summarize, to comply with the impending regulatory overhaul, this extra time, if used constructively, will help manufacturers organize and put a better implementation system in place, enabling compliance with more stringent technical documentation and clinical evaluations.
Changing and Challenging Dynamics
Immediately following this global COVID-19 pandemic, the Medical Devices Regulation (MDR) 2017-745 is extended to 1 year. NBs and device makers face opportunities and challenges based on the delay offers. The most beneficial benefit of the delay in time is the short supply to manufacturers dealing with ongoing changes in device regulatory requirements. In addition, the accelerated time period would likely help manufacturers of class I devices short time to take advantage of the grace period as laid out in the second rectification. However, the additional challenges of Social Distancing and global control introduced by the Pandemic will affect the ability of the NB and maker to move forward.
In short, below are some changes that manufacturers must include on their medical devices:
- Name and Trade name of the devices
- Manufacturing date(if there is no expiry date)
- All device labels should be done standardly, indicating that the package contains a medical device shipped to the European Union.
- A proper description of the device so that a person can understand the packaging content and its purpose of use.
- Licensed EU representative’s information if the manufacturer is based out of the EU.
- Warnings or precautions, if any.
- Serial Number or Lot number, whichever is present
- Unique Identification Carrier
- Labels on the device must be in a human-readable format
More information related to the device is a must for manufacturers to include in the labeling in section 23.2 of the regulation.
Challenges faced by manufacturers
Reclassified and up-classified devices
Under new MDR and IVDR, manufacturers will make changes to how medical devices will be classified, with requirements being progressively examined dependent on the risk caused to the patient.
Whereas reclassification requires a costly certification process for new devices and devices already on the market.
Elevated clinical testing requirements
Another major challenge to be faced by manufacturers is an increase in clinical testing requirements. Under the new IVDR, manufacturers who were not doing clinical testing now have to develop the ability to do so.
For devices that are already on the market, the new regulation will require assessing the clinical data of devices. If the devices do not meet the requirements, devices will have to go for additional testing for recertification.
Increase demand on notified bodies
The new MDR/IVDR increased the demand for notified bodies and decreased the availability of notified bodies. So the workload of a notified body is increased now. This indirectly delays product approval and slows down the process of device entry into the market.
Moreover, NB’s will have to review more data, thus increasing the cost of devices & lengthening the timeline of the device.
Emphasis on post-market surveillance
Post new MDR and IVDR, there will be more focus on post-market surveillance. This includes monitoring device performance for recertification, rapid reporting of safety incidents, and annual safety updates for higher-risk class devices.
The increase in safety and performance reporting may require more resources for device and diagnostic companies. However, these requirements can help manufacturers to find potential issues early in the production cycle.
Ensure compliance early
We all are aware of the challenges we are facing due to the delay of EU MDR. But still, everyone is hoping for the best, as the early transitions will be critical in giving products an edge in the market.
The manufacturer can get rid of this competition by following the below tips:
- Implementing a strategic approach to ensure compliance and make products more relevant to value the conscious customer.
- Partner with CRO to make use of regulatory expertise.
- Hold on to the opportunities to audit portfolios and eliminate products that will not use in the future.
These tips can help manufacturers, medical devices, and diagnostic companies ensure compliance and begin planning immediately.
We know adjusting will take time and effort, but it’s critical for future success.
The delay will give us more time to try out what we have deployed before MDR. In addition, it helped us focus on business continuity and plan for 2020 and 2021. This development means rethinking the planning process for our clients to meet the new timing. For example, a clinical support tool to help clinicians diagnose Covid-19 infection and monitor its treatment received the necessary MDD certification in two months. We’ve heard very recently of the major impact of what’s currently happening.
The EU MDR was set for the delay again but was turned down by the EU Commission. Industry groups have carefully prepared it to sit on their table as a definite truth, with a lack of notified body resources partly due to the delays in notified body designation, with travel restrictions excluding audited areas with the RA and Quality Assurance team in the company mainly working from. This road is blocked by difficulty organizing site visitors for the first VIM and IVDM audits involving the first. The expected clinical benefit will already be limited to the fundamental elements defended in the current CER.