Johnson received some anonymous feedback from a reader who shared the pain points their small medical device company has experienced with the European Union’s convoluted Medical Device Regulation (MDR). According to the reader, their company decided to pull its products from the EU market due to the new regulations. “Way too long, way too expensive to get any notified body to process an application (and we were in the market since 2017 with a product that is low risk and hasn’t changed really since then),” the reader wrote. “Our calculations said we’d have a much better ROI spending that money on extra marketing in the U.S.”
It is a decision I am certain the company did not make lightly. And while it does make sense from a business perspective, it leaves that company’s European customers with one less product to choose from. In her article, Johnson does a solid job of illustrating the problem by using examples from Zap Surgical and Palliare.
San Carlos, CA-based Zap Surgical developed a radiosurgical robot called “Zap-X” for the treatment of cancer and other brain disorders. FDA cleared Zap-X in 2017 and the company received a CE mark in 2021 under the MDR. The problem is the MDR process took roughly twice as long and cost twice as much as the FDA 510(k) clearance. Likewise, Galway, Ireland-based Palliare spent more than 18 months and about €100,000 to receive certification for the company’s EVA15 laparoscopic and endoscopic insufflators under the EU MDR. Under the previous Medical Device Directive (MDD), the process took only a few months and around €15,000.
However, the EU MDR is problematic for reasons beyond cost and commercialization delays. It is the shifting deadlines, ambiguities, and redundancies that are chasing some manufacturers out of the EU market. And at the end of the day, patients and clinicians in that market are the ones holding the short end of the stick. Clearly, something has got to give!
Muna Kebede, a Senior Consultant for Akra Team, a medical device consultancy based near Munich, Germany, said it best. “The industry cannot afford to stay in a system with so many moving targets and uncertainties,” Kebede said. “The lack of clarity, on top of timeline pressures, before the system is fully developed, is a driving factor in the burdens experienced by medical device companies.”
The medical device industry thrives on clarity. When regulatory processes are clouded with uncertainty, innovation is stifled. We have seen this play out before in the U.S. medical device market, and it would behoove the European Commission to learn from FDA’s past mistakes.
Granted, the European Commission had good reason to strengthen the region’s medical device regulations in the first place. High-profile scandals, including the Poly Implants Prothèses (PIP) breast implant scandal, highlighted the need for stricter medical device regulation in the EU. The problem is with the chaotic implementation of the MDR and the barriers it introduces to bringing new devices to the EU market.
While Johnson’s MD+DI article points to some encouraging trends and streamlining tips for medical device manufacturers, the European Commission could do its part by heeding at least some of the MDR Amendments proposed by MedTech Europe. MedTech Europe’s proposal aims to protect innovation in the EU and ensure the availability of legacy devices. One (1) suggested revision is to remove redundant requirements and to resolve conflicting interpretations of Medical Device Coordination Group (MDCG) guidance documents. The organization argues that some reporting requirements could be minimized and simplified without sacrificing protection of health, transparency, and traceability to the benefit of patients and users.
The European Commission should also consider at least some of the 10 demands recently submitted to the European People’s Party by Peter Liese and Angelika Niebler, two (2) German members of the European Parliament. My personal favorite of these 10 demands states, “Deletion of all rules that do not bring security but only bureaucratic effort.” That point may be easier said than done; however, it seems like a reasonable rubric to begin with. It is almost like The KonMari Method developed by Marie Kondo, only for tidying the MDR. Instead of, “Does this spark joy?” regulators should ask, “Does this rule spark safe and effective innovation?”
It is no surprise that Johnson’s article struck a chord, revealing the grim reality faced by small medical device companies. The decision of a small company to withdraw its products from the EU market serves as a poignant reminder of the profound impact these regulations have on businesses. Heeding the proposed amendments by MedTech Europe and the compelling demands from members of the European Parliament is not merely a suggestion; it is an urgent call for action. The EU MDR must undergo meticulous ‘KonMari’ evaluation – discarding rules that contribute only to bureaucratic complexities, while ensuring each regulation sparks safe and effective innovation.
REFERENCE: MD&DI (Medical Device and Diagnostic Industry); 05 FEB 2024; Amanda Pedersen