Gene Therapy Approval and Radio Equipment: Two Regulatory Shifts

Two regulatory developments this week illustrate how quickly the medical device and advanced therapy landscape is evolving—and how easily manufacturers can be caught off guard. The MHRA's approval of beremagene geperpavec (Vyjuvek), a gene therapy for dystrophic epidermolysis bullosa, marks a significant milestone in the UK's post-Brexit ambition to become a fast-follower for innovative therapies. Simultaneously, industry experts are warning that a substantial proportion of medical device manufacturers remain unaware that their products fall under radio equipment regulations—a compliance gap that can derail market access at the final hurdle. These aren't isolated stories; they're symptoms of a regulatory environment where innovation is accelerating faster than awareness, and where technical requirements sit in unexpected corners of the framework.

MHRA's Gene Therapy Approval: What Vyjuvek Tells Us About the UK Pathway

Beremagene geperpavec is a topical gene therapy designed to address wounds in patients with dystrophic epidermolysis bullosa, a rare and debilitating genetic skin condition. Its approval by the MHRA follows regulatory clearance in the United States and signals the UK's intent to maintain pace with the FDA and EMA in advanced therapy medicinal products (ATMPs), despite operating independently post-Brexit.

For regulatory professionals, the significance extends beyond this single product. The MHRA has been vocal about its commitment to agile, science-led regulation—particularly for novel modalities like gene therapies, cell therapies, and combination products that blur traditional boundaries. Vyjuvek's approval demonstrates that the UK pathway is functioning as intended for high-need, innovative products, and that parallel submissions to MHRA alongside FDA or EMA remain viable strategies for sponsors.

However, this also raises questions for device manufacturers working on combination products or diagnostic companions to gene therapies. Where does the device end and the ATMP begin? Who regulates the delivery system for a gene therapy—MHRA's devices team or its ATMPs division? These boundary questions are not academic. They dictate your regulatory strategy, your notified body selection (if applicable), and your post-market surveillance obligations. The rise of gene therapies and their associated diagnostic and delivery technologies means more manufacturers will face these hybrid classification challenges. Early engagement with MHRA is not optional; it's the only way to avoid costly reclassification surprises mid-development.

The Radio Equipment Directive: The Compliance Blind Spot Hiding in Plain Sight

Alexander Toohie's preview of his Med-Tech Expo 2026 session highlights a problem that catches even experienced regulatory teams off guard: many medical devices are also radio equipment, and they're subject to a separate, parallel regulatory regime. If your device contains Bluetooth, Wi-Fi, NFC, or any form of wireless communication, it likely falls under the Radio Equipment Regulations 2017 in the UK (or the Radio Equipment Directive 2014/53/EU in the EU). This isn't a carve-out or exemption—it's an additional layer of mandatory conformity assessment.

The challenge is that radio equipment requirements sit outside the medical device regulations. You can have a CE-marked device under the EU MDR or a UKCA-marked device under UK MDR, and still fail market surveillance checks if you haven't addressed radio compliance. The penalties are real: product recalls, market suspension, and enforcement action from telecoms regulators, not just medical device authorities.

What makes this particularly insidious is the assumption gap. Design teams think, 'We're using a certified Bluetooth module, so we're covered.' Regulatory teams think, 'That's an EMC issue, and we've done EMC testing.' Neither assumption is sufficient. Radio equipment compliance involves spectrum efficiency, effective use of radio frequencies, and specific labelling and documentation requirements that don't neatly overlap with medical device EMC standards. The testing may be similar, but the legal framework and declaration of conformity are distinct.

Toohie's observation—'Even if you don't realise your device is considered radio equipment, it probably is'—is not hyperbole. Connected devices, remote monitoring systems, insulin pumps with wireless data transfer, even some diagnostic instruments with wireless connectivity to printers or hospital IT systems, all qualify. If you're developing a digital health product, a connected wearable, or any device with an app-based interface, you need to address this before design lock.

What This Means for Your Team

These two stories converge on a single theme: regulatory complexity is intensifying, and assumptions are dangerous. For manufacturers working on advanced therapies or combination products, the MHRA's Vyjuvek approval is encouraging—but it also signals higher scrutiny and the need for early, clear classification discussions. Don't assume your device will be classified the same way in the UK as it is in the EU or US. Don't assume that because your product incorporates a therapy, the device components will be waved through.

For teams developing connected or wireless devices, the radio equipment compliance gap is an immediate risk. This is not a future problem or a nice-to-have checklist item—it's a gate to market access. If your technical file doesn't include a declaration of conformity for radio equipment, you're not compliant, regardless of your MDR or IVDR status. The fix is not complex, but it must be planned. Engage with test labs that understand both medical device standards and radio equipment directives. Ensure your technical documentation and labelling reflect both regimes. And if you're using off-the-shelf radio modules, don't assume the module manufacturer's compliance covers your final product—it doesn't.

Both issues also underscore the importance of cross-functional collaboration. Regulatory affairs cannot operate in isolation from R&D, quality, and supply chain. The decision to include wireless connectivity or to develop a delivery device for a gene therapy has regulatory consequences that cascade through classification, testing, documentation, and post-market obligations. These decisions need regulatory input at the concept stage, not at design freeze.

Key Takeaways

• The MHRA's approval of Vyjuvek demonstrates the UK's commitment to fast-tracking innovative therapies, but combination products and diagnostic companions must address hybrid classification early to avoid regulatory misalignment.
• Medical devices with wireless connectivity are subject to radio equipment regulations in addition to MDR/IVDR requirements—this is a separate conformity assessment, not an EMC footnote.
• Assumptions about certified modules or previous approvals do not transfer automatically; each final product must demonstrate radio equipment compliance independently.
• Early engagement with regulators and testing labs is essential for both advanced therapies and connected devices—waiting until late-stage development invites costly delays and redesigns.

The regulatory environment rewards vigilance and punishes assumptions. As gene therapies become more common and connectivity becomes ubiquitous, the boundaries between device, drug, and telecoms regulation will continue to blur. Manufacturers who recognise these intersections early—and build compliance strategies that address them holistically—will navigate market access more smoothly. For everyone else, these blind spots will become roadblocks. If your team is grappling with classification questions, hybrid product strategies, or connectivity compliance, these are exactly the conversations where specialist regulatory insight makes the difference between a smooth pathway and a stalled submission.