PCCPs, CE Marks, and Rare Disease: Three Signals for 2025

Three stories broke this week that look unrelated at first glance: FDA guidance on predetermined change control plans for AI-enabled software, a Lithuanian robotics company securing CE marking for an endovascular system, and MHRA launching a consultation on rare disease therapies. But if you're running regulatory affairs for a medical device company in 2025, these stories share a common thread—they're all stress-testing the adaptability of your quality management system and regulatory strategy right now. The organisations that recognise these signals early will shape their roadmaps accordingly. The ones that don't will be scrambling in Q3.

FDA's PCCP Guidance Is Already Exposing Quality System Gaps

The FDA's predetermined change control plan framework for AI-enabled Software as a Medical Device isn't just guidance—it's a diagnostic test for your quality system. If you work with SaMD teams, you've likely noticed that most can cite the regulatory shift around AI and machine learning. Far fewer have actually read the guidance documents in full. And almost none have walked through what implementing a PCCP would actually require from their current infrastructure.

Here's the reality: a PCCP requires you to pre-specify the types of modifications you anticipate making to your algorithm, the methodology for implementing those changes, and the associated risk management protocol—all before the initial market authorisation. That means your design controls, risk management files, and post-market surveillance feeds need to be tightly integrated and mature enough to support iterative changes without triggering a new 510(k) or PMA supplement for every model update. For most SaMD developers, that level of integration doesn't exist yet.

The practical issue isn't whether your team understands machine learning or algorithm validation. It's whether your quality management system can produce the evidence the FDA needs to trust your change control process. That includes real-world performance data, clearly defined performance boundaries, and a feedback loop that connects post-market surveillance to design iteration. If your current QMS can't produce that chain of evidence cleanly, your PCCP submission will expose it. Better to discover that gap now during internal planning than six months into a submission cycle.

The window to address this is narrowing. As AI-enabled devices proliferate, the FDA will expect PCCP submissions as a standard part of the review process for any device with adaptive algorithms. If your software roadmap includes machine learning components, this isn't a future consideration—it's a current gap analysis that should be underway.

Sentante's CE Mark and the Endovascular Robotics Signal

Sentante, a Lithuania-based company, just secured CE marking for its endovascular robotic system designed for remote stroke intervention. The device was previously accepted into the FDA's Total Product Life Cycle Advisory Program (TAP), which offers early-stage companies iterative feedback throughout development. This isn't just another CE mark announcement—it's a case study in how emerging med-tech companies are sequencing regulatory pathways to reduce time to market and de-risk submissions.

The TAP programme is underutilised, particularly by European companies who view FDA market entry as a later-stage priority. But Sentante's approach—secure TAP engagement early, leverage that feedback to refine design controls and clinical evidence, then pursue CE marking while maintaining an open dialogue with FDA—demonstrates a more strategic use of parallel pathways. The result is a device that enters the EU market with a regulatory file already shaped by FDA expectations, reducing friction when the US submission eventually occurs.

For regulatory teams, the lesson here is about timing and integration. If your device is novel, high-risk, or incorporates emerging technology like robotics or AI, engaging with the FDA's pre-submission and TAP programmes early isn't just useful for the US market—it strengthens your technical documentation and risk management approach globally. CE marking under MDR demands rigorous clinical evaluation and post-market surveillance planning. If you've already structured that evidence to meet FDA scrutiny, your MDR submission is stronger by default.

MHRA's Rare Disease Consultation: A Brexit Regulatory Dividend?

The MHRA's consultation on a new regulatory framework for rare disease therapies is the UK's latest attempt to differentiate itself post-Brexit and attract life sciences investment. The consultation proposes tailored pathways for orphan drugs and rare disease medical devices, with the explicit goal of making the UK a global leader in this space. The timing is deliberate—while the EU's regulatory apparatus remains complex and slow-moving for niche indications, the MHRA is positioning itself as nimble and innovation-friendly.

For device manufacturers with rare disease indications, this is worth paying attention to. The UK market alone doesn't justify a standalone submission for most companies, but if the MHRA can deliver on streamlined pathways with mutual recognition agreements or data-sharing arrangements with other regulators, it could become a strategic first-approval jurisdiction. That's particularly relevant for devices targeting paediatric rare diseases or ultra-orphan conditions where patient recruitment for clinical trials is a bottleneck.

The question is execution. The MHRA has announced ambitious reforms before—remember the proposed UKCA mark transition deadlines—and implementation has been uneven. But if this consultation results in clear guidance, reduced timelines, and genuine engagement from notified bodies and clinical evaluators, it could shift where companies prioritise their first regulatory submissions. At minimum, it's worth responding to the consultation if your portfolio includes rare disease devices. Regulatory frameworks are shaped by industry input, and early engagement gives you influence over the final requirements.

What This Means for Your Team

If you're managing regulatory affairs for a device company right now, these three signals point to the same strategic priority: your quality management system and regulatory strategy need to be more adaptive and forward-looking than they were 24 months ago. The regulatory environment is fragmenting—different pathways for AI, different timelines for rare diseases, different expectations across FDA, MHRA, and EU MDR. The companies that thrive in this environment won't be the ones with the most resources. They'll be the ones with the most integrated systems and the clearest strategic vision.

For SaMD teams, that means conducting an honest gap analysis of your quality system's readiness for PCCPs now, not when you're six months from submission. For novel device developers, it means engaging with pre-submission programmes early and thinking about regulatory pathways in parallel, not sequentially. For rare disease device manufacturers, it means monitoring the MHRA consultation and considering whether the UK could become a strategic first-approval market if the framework delivers on its promise.

The common thread is proactivity. Regulatory frameworks are evolving faster than they have in a decade, and the gap between early adopters and late responders is widening. The teams that treat regulatory strategy as a dynamic, continuously updated process—not a checkbox before launch—will be the ones that move faster, reduce submission risk, and enter markets ahead of competitors.

Key Takeaways

• FDA's PCCP framework for AI SaMD is exposing gaps in quality systems now—conduct an internal readiness assessment before those gaps become submission blockers.
• Sentante's CE mark demonstrates the value of engaging FDA's TAP programme early, even for EU-first companies, to strengthen global regulatory files.
• MHRA's rare disease consultation could create a new strategic first-approval pathway for niche indications—respond to the consultation if it's relevant to your portfolio.
• Regulatory strategy in 2025 requires parallel pathway thinking and tighter integration between QMS, risk management, and post-market surveillance across jurisdictions.

Regulatory affairs has always required you to anticipate change, but the pace of that change has accelerated sharply. The stories that broke this week aren't isolated data points—they're signals about where the regulatory landscape is heading. If your team is still operating with a compliance-only mindset, these shifts will feel disruptive. If you're already thinking strategically about how regulatory pathways intersect with product development, they're opportunities. At SMEDTEC, we work with teams to turn regulatory complexity into competitive advantage. That starts with knowing which signals matter—and what to do about them before the rest of the market catches up.