Looking Forward: EU Medical Devices Regulation | Kilpatrick Townsend & Stockton LLP

At the end of each year, we have a habit of looking back at lessons learned, the ups, the downs, the works. And like in 2020 and 2021, the COVID-19 pandemic and related shortage of medical devices take center stage in our reflections as a community. Even now the US FDA continues to update its lengthy “Medical Device Shortages During the COVID-19 Public Health Emergency” list. But this year, not all is terrible. In fact, the FDA removed products from that list as opposed to adding more in its latest update on December 12th,1 indicating an improvement in circumstances at least in the United States.

Unfortunately, we cannot say the same for our friends in the EU, who are currently experiencing a second wave of medical device shortages. And this time, it may be self-induced.

The EU’s new Medical Devices Regulation (MDR) came into force just last year and replaced various directives that had been in place since the 1990s.2 Given the leaps and bounds the world has made in the medical devices field in the 21st Century, the MDR likely provides a much-needed update to better reflect current needs. However, the transition has been met with significant growing pains, further exacerbated by the still-ongoing COVID-19 pandemic.

How It Started:

The Commission had already planned for an eventual overhaul of its medical devices regulatory framework in as far back as 2009.3 However, in 2010, French authorities discovered that Poly Implant Prothèse (PIP), the world’s third largest supplier of breast implants at the time, had been using industrial-grade gel instead of medical-grade, making the implants more likely to rupture and result in inflammation and scarring.[4] As a result, PIP’s founder was eventually found guilty of fraud and sentenced to four years in prison.5

Driven by the scandal and the fact that PIP’s defective implants had passed regulatory muster due to loopholes, the Commission set out to introduce even greater safety requirements and stricter certification processes.6 This resulted in the MDR, which was adopted by the European Parliament and the Council in 2017 with plans for it to go into effect in 2020.7

Early 2020, however, marked the start of the COVID-19 pandemic and the resulting global medical devices shortage. The Parliament and Council recognized the importance of maximizing availability of medical resources in light of these developments and adopted the Commission’s proposed one-year delay in implementation of the MDR.8

How it’s going:

Following the one-year delay, the MDR came into force on May 26, 2021, requiring manufacturers, importers, and distributors to conform to the new heightened regulations for both new and old products upon the expiration of any existing certification. However, the increased standards of the MDR have correlated directly with increased costs for companies, reportedly by 3-10 times, leading many to simply drop products from their offerings instead.9 In addition, even for companies choosing to bring their products into conformity, the time it takes to get certification for products has also increased significantly, sometimes from months to years.10 The result has been a substantial shortage of medical devices, especially those for rarer conditions that companies no longer find profitable.

The Commission has recognized this issue, though it cites the ongoing COVID-19 pandemic and Russia’s war against Ukraine as root causes instead, and plans to consider an extension of deadlines for companies to conform to the MDR.11 Though the plan is not officially tabled yet, the tentative proposal sets new staggered deadlines: 2027 for “high risk” devices and 2028 for “low risk” devices.12 The Health Commissioner further noted in her remarks on December 9th that these new deadlines should be subject to yet-undisclosed conditions , as “[o]nly devices that are safe should benefit.”13 Finally, the tentative proposal completely removes the May 2025 sell-off date, thereby preventing waste of devices already on the market.14

The proposed amendment to the MDR is set for consideration at the beginning of the new year. Should the amendment be adopted, whether another deadline extension will solve the problem at hand or simply punt the issue further down the line will remain to be seen.

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