Your Regulatory Gateway to New Medical Device Markets (Europe & GCC)

🇦🇪🇪🇺 LIS Consulting (Reg. No. DSO-FZCO-7648) is a Dubai-based regulatory affairs consultancy specialising in end-to-end support for manufacturers seeking compliant market access in Europe and the Middle East. Founded and operated from Dubai Silicon Oasis, LIS Consulting brings deep regulatory expertise across a broad range of product categories: medical devices, in-vitro diagnostics (IVDs), Software as a Medical Device (SaMD), AI-driven medical devices, and personal care products. Our consultants guide clients through every stage of the regulatory lifecycle from initial strategy and gap analysis, to technical documentation, clinical evaluation, submission management, and post-market obligations. Whether you are preparing a CE marking dossier under MDR 2017/745 or IVDR 2017/746, navigating Gulf market registrations, or bringing an AI-powered device to market for the first time, we provide the expertise and hands-on support to get you there efficiently and compliantly. Our areas of expertise include: Medical devices (Class I to III) CE marking, MDR, Gulf & MENA submissions In-vitro diagnostic devices (IVDs), IVDR compliance and registration Software as a Medical Device (SaMD) and AI-driven medical devices Personal care and cosmetic products.

About Us

Healthcare Regulatory Affairs in the UAE and Other GCC Countries.

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Our Services

✅ Our Regulatory Services cover the UAE 🇦🇪, the Gulf Cooperation Council (GCC), and Europe 🇪🇺

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Contact Us

📞 Contact LIS Consulting – Healthcare Regulatory Experts in Dubai

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Bringing an AI-powered diagnostic tool to the European market

The situation

A medtech startup had developed an AI-powered image analysis software designed to assist radiologists in detecting early-stage lung nodules. Clinically promising and technically robust, the product was ready for commercialisation — but the regulatory pathway to the European market was far from straightforward. The company approached LIS Consulting to define a compliant route to CE marking.

The challenge

AI-driven diagnostic tools sit at the intersection of two complex regulatory frameworks. First, the software had to be qualified and classified as a Software as a Medical Device (SaMD) under MDR 2017/745. Given its intended purpose — directly influencing clinical decisions — it was classified as Class IIb, triggering mandatory notified body involvement. Second, because the output of the software informed diagnostic conclusions, questions arose about whether IVDR 2017/746 applied in parallel. A thorough intended purpose analysis was required to draw the boundary clearly.

Beyond classification, the AI/ML nature of the product introduced additional layers of complexity:

  • The clinical evaluation could not rely solely on equivalence — original clinical data was required to demonstrate diagnostic performance.
  • The algorithm’s continuous learning capability raised questions about substantial modifications and when a new conformity assessment would be triggered.
  • Explainability of the AI model had to be addressed both for regulatory purposes and for the intended clinical users.

Our approach

LIS Consulting led the regulatory strategy from the ground up. We produced a detailed SaMD qualification and classification rationale, aligned with the MDCG 2019-11 and MDCG 2021-24 guidance documents. We then built the clinical evaluation plan, identifying relevant clinical studies, defining the performance endpoints, and structuring the clinical evidence to satisfy the notified body’s requirements under Annex XIV of the MDR.

We also drafted the Article 55 substantial modification procedure so the manufacturer had a clear, pre-agreed process for handling future algorithm updates avoiding costly re-submissions down the line.

The outcome

The product achieved CE marking under MDR 2017/745 (Class IIb) within 18 months of engagement. The manufacturer now has a robust technical file, a fully documented clinical evaluation report, and a post-market clinical follow-up plan that satisfies ongoing MDR obligations.

Navigating AI device regulation in Europe? LIS Consulting can define your pathway. contact@lisconsultgroup.com