The Delay of EU MDR – What It Means For Your Medical Devices
With the global COVID-19 pandemic disrupting industries, stakeholders in the medical devices industry have rapidly diverted efforts from the short-term urgency of ensuring regulatory compliance by 26 May 2020, to ensuring the immediate delivery of vital medical devices.
Given that 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 26 May 2020, the one-year postponement to the enforcement of the EU MDR and extension of 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 protection of public health and patient safety, it is necessary to defer the application of certain 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.
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 at providing manufacturers additional opportunities to extend MDD certificates, and provides additional time to prepare their Quality Management Systems (QMS) to meet the stricter post-market surveillance requirements. Medical Device Coordination Group (MDCG’s) post market clinical follow-up plan (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 demonstrating equivalence.
It is possible that in order to address shortages of vitally important medical devices in an effective manner, certain MDR-related transitional provisions will apply which will allow national authorities to place certain 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 class Is, Im or Ir) under the MDR, will have an additional one year in which to ensure their self-certificated class I devices meet MDR requirements.
Additionally, Corrigendum 2 proposed in December 2019, stipulates that a four-year transitional period will be provided for certain low-risk medical devices such as certain software which are 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 25 May 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 in order to fight the pandemic. Despite the introduction of remote assessments over the next year, there will be even fewer resources available to conduct MDD certificate renewals. Further remote assessments 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. 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.
Class I: If a Class I device requires the involvement of a Notified body and the device is on a Declaration of Conformity prior to May 26, 2021, 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 (eg sterile or measuring) that have 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), inhalers.
IVDR: This delay in MDR enforcement does not impact the In Vitro Diagnostics Regulation (IVDR), which will still come into effect from 26 May 2022. However, the Industry group MedTech Europe argued that IVD manufacturers working round the clock to rapidly bring novel coronavirus diagnostics to market are also in need of more time to achieve compliance.
Recommendations for Medical Device Manufacturers:
Given the current adverse global scenario, despite the extended timeline many companies will still be behind on their compliance and thus will need to use their time wisely.
Start the review process early: It is suggested that manufacturers evaluate their MDR transition plan taking into consideration 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 extent of benefit for manufacturers is largely dependent on how their Notified Body decide 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, in order to comply with the impending regulatory overhaul, this extra time, if used constructively, will help manufacturers get organized, put a better implementation system in place, enabling compliance with more stringent requirements for technical documentation and clinical evaluations.