The new In Vitro Diagnostics Regulation (IVDR) and Medical Device Regulation (MDR) provide regulatory frameworks and conformity assessments that promote medical device safety and efficacy.
Under these new regulations, notified bodies (NBs) — which are defined as organisations that have been designated by a member state to evaluate the conformity of products prior to their release in the EU market — will serve as enforcers, evaluating all medical devices (excluding IVDs) above Class I and IVDs above Class A. This accounts for approximately 90 percent of all IVDs, up from about the previous one percent under the old IVDR directive, which will increase NB workloads and decrease NB availability.1 In addition to considerations related to NB access, the COVID-19 pandemic has significantly disrupted progress towards compliance with MDR and IVDR, compounding pressures on NBs.
With deadlines to comply with these regulations having arrived or rapidly approaching, readiness is essential for the industry to minimise medical device shortages. Here we explore how the industry has responded to these obstacles and discuss key considerations for device manufacturers as they prepare to meet the increased requirements of MDR and IVDR.
NB shortages under MDR and IVDR
To exacerbate the challenges associated with increased workloads on NBs, there is currently a lack of NBs under the new regulations. As of May 12, 2021, only 20 NBs have been designated under the MDR, compared to 54 under previous directives. Similarly, there are just four designated NBs under IVDR, whereas the current directive has 21.2 These two factors, combined, create a significant bottleneck, which could delay the product approval process leading to limited market access to products.
To alleviate the strain on NBs, trade groups are urging authorities to encourage manufacturers to make MDR submissions before their current certificates end in 2024. This would spread the workload of notified bodies more evenly over the next few years. As the industry awaits these efforts, manufacturers may benefit from reaching out to their chosen NB as soon as possible to check whether they intend to apply for designation under MDR. When making these inquiries, it is critical to investigate the scope they intend to cover, as well as when they think they will be ready to apply.
Impact of COVID-19 on compliance efforts
In addition to the demands placed on NBs by MDR and IVDR, alone, COVID-19 restrictions continue to prevent many on-site audits by NBs due to limitations around travel and in-person meetings. This has resulted in a push for the expansion of remote audits, which have been prohibited for new certifications, unless a case-by-case assessment deems them “relevant to ensure medical care, especially if clinically necessary during the period of COVID-19 restrictions.”3
Although the industry has increasingly implored the European Commission to implement remote audits more widely, some opposition and country-to-country variation within the EU has made it difficult for Team NB to finalise a position on the matter.4 As such, working with an experienced partner can help manufacturers navigate the complexity of obtaining remote audit permissions for medical devices.
A recent poll of medical device manufacturers reported that MDR is challenging and costly, with three quarters of respondents wanting clearer guidelines from the European Commission on how to comply with new regulations. The majority of respondents cited their greatest barriers as increased resources/costs, lack of clarity and required clinical investigations. These obstacles have been exacerbated by workflow bottlenecks due to NB shortages and the disruption of the COVID-19 pandemic. Nevertheless, MDR and IVDR will be implemented according to schedule. This means that manufacturers need to work towards compliance as soon as possible to secure the best outcome for their organisation’s transition. Contact us to learn more about how ICON can help navigate these new regulations.
- Quality Support Group. EU MDR and IVDR: Implementing the EU’s New Medical Device Regulation. https://qualitysupportgroup.com/eu-mdr-ivdr/
- Oriel: Medical Device Regulatory/Quality Training and Consulting. Which EU Notified Bodies Have Been “Designated” Under the MDR 2017/745 and IVDR 2017/746. 2021. https://www.orielstat.com/blog/eu-notified-bodies-designation-status-mdr-2017-745/
- European Commission. Guidance on temporary extraordinary measures related to medical device Notified Body audits during COVID-19 quarantine orders and travel.2020. GROW.DDG1.D.DIR restrictions. https://ec.europa.eu/docsroom/documents/40705?locale=en
- Nick Paul Taylor. EU remote audits under MDR in doubt as divergent national positions persist. MedTech Dive. https://www.medtechdive.com/news/team-nb-pulls-remote-audit-plan-questions-persist/596444/