EU MDR Delays

by Madison Green | Jul 26, 2022 | Audits, Blog, Certificates, Classification, Compliance, Consulting Group, COVID-19, Documents, Engineering, EU, EU MDR, FDA, Guidance, Inspections, Pharma, Pharmaceuticals, Quality, Quality Systems, Recall, Registration, Regulatory, Requirements, Risk Management, Safety, Standardization, Standards, Testing, Tools, Updates, Verification

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It is no surprise to anyone in the medical device industry that the transition from EU MDD to EU MDR has seen quite a few hiccups over the past couple of years. The most recent obstacle, however, comes in the form of delays from Notified Bodies. The scale of the bottleneck coming from Notified Body capacity to review EU MDR applications has not been a secret, but a recent industry poll sheds light on the growing concern.

In April of this year, the Medical Device Coordination Group (MDCG) task forced polled industry members to better understand how limited Notified Body capacity was affecting them. According to the poll, nearly 85% of products previously certified under MDD are still awaiting MDR review by Notified Bodies. This accounts for nearly 500,000 devices that were previously on the European Market under MDD and are actively awaiting MDR review.[1]

These are staggering figures that shine a hard-to-miss spotlight on some of the major downfalls of the rocky transition. These issues are major concerns for larger companies but are potentially disastrous for smaller to medium-sized companies attempting to gain a foothold in the EU market. Considering some of these challenges, some companies have decided to pull their products from the EU market altogether by reducing product portfolios for European customers. This, in turn, could mean a reduction in accessible medical treatments for patients.

The bottleneck in the review phase is equating to an average 13–18-month MDR certification, which only heightens to criticality for medical device manufacturers to get started ASAP on their transition and final application submission. While these figures are certainly abysmal, not all hope is lost. Slowly but surely Notified Bodies are optimizing their review processes to continue to improve speed without compromising a robust review.

If you need assistance with EU MDR Transition or working through the certification process, contact EMMA International at 248-987-4497 or email info@emmainternational.com today!

_{[1] MedTech Europe (July 2022) Analyzing the availability of Medical Devices in 2022 in connection to the MDR implementation retrieved on 07/25/2022 from: https://www.medtecheurope.org/resource-library/medtech-europe-survey-report-analysing-the-availability-of-medical-devices-in-2022-in-connection-to-the-medical-device-regulation-mdr-implementation/}

Madison Green

Director of Technical Operations - Mrs. Green serves as EMMA International’s Director of Technical Operations. She has experience in technical writing, nonconforming product management, issue evaluations, and implementing corrective and preventative actions in the pharmaceuticals and medical device industries. She has experience cross-functionally between R&D, lean manufacturing operations, and RA compliance. Mrs. Green also has academic and work experience with human health-risk engineering controls, physiological biophysics, and clinical research. Mrs. Green holds a Bachelor of Science in Biosystems Engineering with a concentration in Biomedical Engineering from Michigan State University. She is also a Certified Quality Auditor (CQA), and is currently pursuing her M.S. in Quality Management.