In a significant move for the global medtech landscape, the European Commission has initiated a targeted revision of the Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR). This response to widespread calls from the medtech sector aims to streamline regulatory processes, cut costs, and expedite market access. Stakeholder consultations are currently open, with a feedback period running from 08 September 2025 to 06 October 2025, and legislative proposals are expected later this year or early next.
For UK-based facilitators like Excellence First Enterprise Consultancy (EFEC) and our partners, this development is particularly promising. It not only bolsters opportunities for UK innovators but also creates a more accessible pathway for international firms—especially those from China—seeking entry into the UK and EU markets. As EFEC prepares for the official launch of the UK-China Life Sciences Innovation Hub in 2026, these revisions align perfectly with our efforts to build stronger cross-border connections.
Streamlined Compliance for Global Innovators
The proposed revisions address key pain points in the current framework, including convoluted certification procedures, inconsistent approval timelines, and escalating costs. By focusing on SMEs and innovative startups, the updates promise to accelerate the journey from concept to patient impact.
For Chinese medtech companies eyeing expansion into Europe, these simplifications are a game-changer. Post-Brexit, navigating dual UK and EU regulations has been challenging, but the revisions introduce more predictable timelines, risk-based assessment pathways, and digitalised processes. This reduces bureaucratic hurdles, enabling faster and more cost-effective market entry. Through our upcoming UK-China Life Sciences Innovation Hub, EFEC will act as the trusted facilitator, connecting Chinese firms with expert partners in regulatory compliance to ensure seamless alignment with both UKCA (UK Conformity Assessed) and CE marking standards. We are bridging cultures and systems in preparation, enabling future collaborations that leverage complementary strengths without EFEC directly providing specialised services.
Enhanced Opportunities for UK-China Collaboration
The revisions foster greater predictability, allowing businesses to plan international strategies with confidence. For UK partners collaborating with Chinese innovators, this means expanded avenues for joint ventures, technology transfers, and supply chain integrations. Chinese companies, renowned for their rapid innovation in areas like AI-driven diagnostics and advanced biomaterials, can now leverage these changes to bring cutting-edge products to European patients more efficiently. At EFEC, we see this as an opportunity to strengthen UK-China ties in medtech as we gear up for the Hub’s 2026 launch. As a seasoned facilitator with two decades of experience in building high-trust partnerships, EFEC is preparing to connect Chinese clients with the right UK and EU experts for cross-border navigation. Whether it’s facilitating introductions for gap analyses, technical documentation, or Notified Body interactions, the forthcoming Hub will empower Chinese firms to overcome barriers and thrive in the UK and EU. We also collaborate with UK partners, including Medilink Midlands members, to build robust networks, fostering mutual growth and innovation exchange—always emphasising responsible, ESG-aligned, and transparent collaborations.
EFEC’s Engagement and Future Support
We encourage Medilink Midlands members and potential partners to stay updated on these developments, as the European Commission has opened a call for evidence on the MDR/IVDR revision, with a feedback period running from 08 September 2025 to 06 October 2025. Contributions may be submitted here until 6 October 2025 (midnight Brussels time).
This signals a more collaborative and innovation-friendly UK-EU medtech ecosystem. As we prepare for the planned 2026 launch of the UK-China Life Sciences Innovation Hub, EFEC is committed to fostering trusted connections between Chinese enterprises and UK/EU markets. Our ongoing efforts focus on building a platform to support future collaborations, helping Chinese firms and UK partners navigate the evolving regulatory landscape.
For Chinese medtech companies exploring UK or EU opportunities, or UK entities interested in collaborating with China, EFEC is available to discuss how these regulatory changes could shape future opportunities. Contact us to learn more about our work in facilitating UK-China partnerships.
Article provided by Medilink partner EFEC. If you have any queries, please contact:
Lily Lin, Co-Director & CEO, Excellence First Enterprise Consultancy Ltd. T: 01992 522285 E: lily.lin@excellence-first.com