How Approaching MDR/IVDR Deadlines Are Impacting Med Device Industry

As the deadlines for Medical Device Regulations (MDR) and In Vitro Diagnostics Regulations (IVDR) loom, both the medical device industry and the European Commission (EC) are finding themselves in a logistical logjam. Thousands of medical device technologies are currently in use that need to be re-certified under the new regulations by May 2020 for MDR and 2022 for IVDR. With time slipping away, and without the necessary regulatory elements in place to achieve compliance, MedTech Europe remains steadfast in urging the European Commission (EC), European Parliament (EP) and all European Union (EU) member states to stop the clock on the transition until the complete regulatory system is in place.

New Regulations

The MDR and IVDR were established as a way to better ensure a high level of quality and safety for medical devices.¹ In short, the new regulations are intended to increase the transparency of the approval and usage of medical devices, as well as improve patient experiences and outcomes.

Under the new regulations, medical devices and in vitro devices must receive a CE Mark (symbol for European Conformity to regulations established by the EC, EP and EU member states) by the established deadlines. Med devices without the MDR/IVDR CE Mark won’t be permitted to be sold in the EU, which means they won’t be available for use in health care systems.

Countdown to the New Regulations

The transition clock for MDR/IVDR started ticking on May 25, 2017. It could be argued that there has been plenty of time to make the move. However, according to MedTech Europe, there is still a lot to do in a short amount of time, and it’s not because medical device manufacturers are dragging their feet. The organization posted a policy paper, “Implementing the New MD and IVD Regulations: Industry Calls for Solutions to Ensure Continuity of Care to Patients,” dated July 2018, which contends that the mandated MDR/IVDR is still a few essential elements short of a full regulatory system.

Lacking Standards and Guidelines

While not all med device manufacturers have been putting in overtime to prepare for the move, the companies that have been making an effort are having to chart their own course. The transition to the new regulations was to be accompanied by essential standards and guidelines to provide a common interpretation of how to correctly apply the new regulations.

Industry experts maintain that these pieces have been slow to materialize. “Many of our clients [medical device companies] have been diligently working on compliance with the new regulations, but they have been working without the benefit of any guidance to ensure they are doing things correctly,” said Adam Cargill, senior associate, life science core operations, KPMG.

Notified Body Deficiency

The entities capturing most of the MDR/IVDR spotlight are Notified Bodies, as they are responsible for assessing and re-certifying medical devices for the new regulations. However, before a Notified Body can dub any medical devices compliant, it must be re-designated as an agency that is qualified to perform the re-certifications.

One of the biggest bottlenecks for MDR/IVDR compliance is the lack of designated notified bodies available to perform the re-certifications. In its policy paper, MedTech Europe expressed concern about the status of this critical element, “As of today, our assessment is that Notified Body availability with needed expertise and sufficient capacity cannot be ensured early enough and hence an urgent solution is needed,” said MedTech Europe.² The organization cited the following scenarios to reinforce its concerns:³

• Re-designation requirements – Qualifying to perform medical device re-certification takes 18 months per Notified Body. Notified Bodies also need to demonstrate a certain level of expertise in their scope of designation.
• An already daunting workload – Thousands of medical devices and technologies are waiting in the queue to be re-certified. These include devices currently on the market, existing products that need to be certified for the first time due to changes in the regulations and new products entering the market.
• Building the necessary workforce – Not all Notified Bodies are in a position to become re-designated to handle re-certifications. Those that do apply and achieve re-designation will need additional time to recruit and train staff in order to cover the re-certification workload.
• The Brexit unknowns – The inevitable departure of the U.K. from the EU in early 2019 will initially pose more questions than answers. Among the most frequently asked questions is if the U.K.’s Notified Bodies will be able to continue operating in the EU. If not, the remaining EU Notified Bodies will need to pick up their workloads.

Given the precarious circumstances surrounding Notified Bodies, med device companies that have yet to begin their transition efforts could be at risk if the MDR/IVDR deadlines remain intact.

Not-So-Graceful Grace Period

Both MDR and IVDR extend a grace period to certain existing products. The grace period, which ends on May 26, 2024, allows for devices with a valid certificate issued under the current regulatory system, the Medical Devices Directive (MDD), to be placed on the market beyond the end of the transition periods. However, there are caveats to this arrangement:⁴

• Legacy devices must have an up-to-date CE Mark under the current MDD from a Notified Body to stay on the market.
• Device certificates based on the current MDD must still be renewed before the respective 2020 and 2022 deadlines.
• The med device industry still faces a time crunch, as Notified Bodies must manage these renewals at the same time they’re working on other obligations, such as fulfilling their re-designation requirements and handling their existing workloads.
• The design, scope or intended purpose of a medical device cannot be changed during the grace period.
• Manufacturers of products cannot apply for MDR/IVDR re-certification of these products after the deadline.

It remains unknown whether the European Commission will accede to MedTech Europe’s request for a freeze on the remaining MDR/IVDR transition time. There are still concerns to be addressed on both sides. Meanwhile, regulatory officials maintain that the new regulations are necessary to improve public health, which suggests that manufacturers should strive to meet the deadlines. ⁵

References:

1. Regulation (EU) 2017/745 of the European Parliament and of the Council: On medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.L_.2017.117.01.0001.01.ENG&toc=OJ:L:2017:117:TOC
2. “Implementing the New MD and IVD Regulations: Industry Calls for Solutions to Ensure Continuity of Care to Patients,” MedTech Europe, July 2018. http://www.medtecheurope.org/sites/default/files/resource_items/files/MTE_PolicyPaper_MDRIVDRImplementationCallforSolutions_July2018.pdf
3. “Medical Device Regulation: What’s the Impact on Notified Bodies?”, Brooks, Paul, Med-Tech Innovation News, 21 Feb. 2018. https://www.med-technews.com/features/medical-device-regulation-whats-the-impact-on-notified-bodi/
4. “This Is It: MDR and IVDR Texts Now Ready for Final Voting,” Vollebregt, Erik, MedicalDevicesLegal, https://medicaldeviceslegal.com/?s=MDR%2FIVDR+grace+period
5. “Tight Deadlines for ER MDR, IVDR Generate Questions for EC, Competent Authorities,” Brennan, Zachery, Regulatory Affairs Professionals Society (RAPS). https://www.raps.org/news-and-articles/news-articles/2018/5/tight-deadlines-for-eu-mdr-ivdr-generate-question