ICYMI: MED-EL’s Maiden Journey Through the MDR

ARTICLE SUMMARY:

Hearing implant maker MED-EL is one of the first firms to have gained CE marks under the EU Medical Device Regulation. Its story holds value for the medtech industry at large, to help it understand what awaits it and what the routine facts on the ground will be once the MDR wave hits in full.

The EU Medical Device (and IVD) Regulation has been viewed in the manner of an oncoming tsunami for the better part of the past decade. The sense of impending doom continues as industry embarks on the extra-year postponement of the MDR amid COVID-19 challenges. But all of that forward-looking angst can conceal a crucial reality: the MDR is already happening. There are companies that have started undergoing conformity assessments against the new legal regime and there are a select few that have made it through, winning the first trickle of CE marks under the regulation. Those companies have stories to tell that hold value for the industry at large, to help it understand what awaits it, what the routine facts on the ground will be once the MDR wave hits in full.

One such firm in that select group of early MDR adopters is MED-EL. The Austria-based, privately owned company is a global hearing implant innovator. MED-EL’s corporate director for regulatory affairs Elizabeth Gfoeller dove straight into the MDR waters four-to-five years ago, and is now sticking her head back up to the surface to report this: the currents are no doubt choppy and require complex maneuvering, but they’re passable, at least for existing devices. In March, just before COVID-19 restrictions hit, MED-EL become one of the first companies to win MDR certifications (including for Class III implantable devices, and QMS certificates for lower-risk products, all part of the firm’s already-marketed portfolio).

That success resulted from MED-EL’s decision to prioritize an MDR focus early on. Gfoeller acknowledges her company was in a relatively good starting position to make the leap. For one, MED-EL’s devices have been subject to the EU’s Active Implantable Medical Device Directive—the jump from the AIMDD to the MDR is less dramatic than the relatively more substantial ramp-up in requirements that lower-risk devices will experience in the move from the Medical Device Directives to the MDR. In addition, the Austrian firm has a long-standing business relationship with one of the largest notified bodies, TÜV SÜD, which is headquartered in neighboring Germany and was one of the first to win an MDR designation last year.

On the other hand, MED-EL likely faced a particularly thorough assessment from notified body reviewers who were anxious to ensure the first MDR assessments that they conducted stuck to the letter of law and left no stone unturned. Also, as the assessment proceeded, TÜV SÜD was still coming to terms with all of the details of the new requirements, and European Commission guidance documents were being released in the midst of MED-EL’s conformity assessment, forcing adjustments by the company and the notified body mid-stream.

But Gfoeller suggests it was worth it to be out in front of a completely new framework, when there is still a lot of room for interpretation. She suggests the process may have allowed her and her colleagues to have an influence on how the MDR is implemented over the longer term.

MED-EL, to be clear, did not come to its positions on the MDR lightly. It embarked on a whole lot of internal research and preparation that kicked off in 2016, even before MDR was official EU law.

A key motivation behind MED-EL’s early focus on the MDR was ensuring the Austrian company’s global—not only EU—market strategy. It was also important specifically to be the first hearing implant manufacturer to make the MDR grade, she notes. “There are only four of us, really. We're not going to potentially let our competitors dictate how this particular code will be applied to our devices. We want to continue to lead here.”

As a result, in 2016 Gfoeller and her team made a commitment—even before the regulations were made final—to figure out what would be required to achieve compliance for its products under the MDR and they started hunkering down.

That started with a deep reading of the MDR, including close attention to quality management systems, clinical evaluations, the regulations newly framed “General Safety and Performance Requirements,” among an array of other topics. That was followed by across-the-board gap analysis of the company’s systems and processes, which was performed in parallel by multiple work groups of subject matter experts focusing on different functional regulatory and compliance topics.

While all this was happening internally, MED-EL also remained in close contact with its notified body, TÜV SÜD.Any sort of consulting by a notified body to its client is off limits, but MED-EL was able to use the interactions to keep TÜV SÜD filled in on its progress, which turned out to be a valuable exercise.

When TÜV SÜD finally gained its MDR designation in May 2019, MED-EL was not only ready on a technical level, it was also very much on the notified body’s radar. At the time,TÜV SÜD was not employing an all-comers approach to the MDR. It wanted to start slowly to ensure that it rolled out the new rules correctly. To do that, it launched an MDR pilot in which it would select particular companies to undergo the first MDR technical document reviews and audits. By early summer, MED-EL was selected to participate in the pilot and was allowed to start making its MDR submissions.

Before reaching the finish line, the company also had to undergo a Quality Management System audit, which occurred in November 2019.

MED-EL made it to the other side of the MDR, and it did so before the pandemic and all of its related delays and restrictions set in. (“Thank goodness,” Gfoeller says.) But big challenges remain.