That's not a criticism of the EU MDR. It's the outcome.
The PIP breast implant scandal, the metal-on-metal hip failures, a series of high-profile device problems in the 2000s and 2010s: Europe's old regulatory system had weaknesses, and they were serious. The MDR was the response. Raise the bar for Notified Bodies, tighten clinical evidence requirements, strengthen post-market surveillance.
The intent was sound. The execution created a capacity problem the industry is still absorbing.
Notified Bodies: from over eighty under the old Directive, to roughly forty with valid MDR designation today. Average certification wait: six to twelve months before review begins, then thirteen to eighteen months of review. Most first submissions arrive with documentation deficiencies that reset the clock entirely. Nineteen Notified Bodies hold scope to assess reprocessed single-use devices under Article 17. Certificates issued on that pathway so far: zero.
Dentaurum, a German manufacturer founded in 1886, withdrew approximately 1,000 products from the EU market. Not because they were unsafe. Because MDR transition costs exceeded what those products could generate in revenue. Hoffmann Dental Manufaktur pulled Proxifungine, a proven Class III device, for the same reason. Orphan devices serving small patient populations are disappearing from European markets.
A regulation designed to protect patients is removing devices from the patients it was meant to protect.
On the other side of the Atlantic, an FDA 510(k) review takes three to six months.
The old sequence — Europe first, then US — was logical when CE marking was faster and cheaper than a 510(k). That logic no longer holds. A UK or European medical device company can now reach American patients before European ones. The fastest route to first revenue, for a European company, is the US market.
That's not a regulatory observation. It's a commercial restructuring event.
The funding model changes: companies that used to generate early European revenue to fund a more expensive US launch now need to fund the US launch first. The hiring sequence changes: year-one commercial leadership needs CPT code strategy, CMS payer engagement, and GPO navigation before it needs NHS procurement knowledge. The brief for a VP Sales or VP Market Access hire in 2026 is materially different from the same brief in 2019.
The European Commission published a reform proposal in December 2025. The legislative process, trilogue negotiations and all, means it can't take effect before 2027 at the earliest. Public consultation respondents called the current system "unreasonably complicated," "terrible for EU patients and doctors," and "a mess."
The Channel Tunnel opened in 1994, eventually. Eurotunnel's board had built the commercial plan around a regulatory assumption rather than building the commercial plan around the regulatory reality.
The companies still planning European market entry on MDD-era timelines are making the same calculation.
Regulatory timelines aren't an input into the commercial plan. They are the plan.
If you've lived this — either leading a regulatory function across both pathways simultaneously, or as a CEO who changed the market entry sequence because of MDR — I'd genuinely like to hear how it played out. What changed, and what surprised you.