MedTech Regulatory Insights March 2025

On January 17, 2025, the European Medicines Agency (EMA)
published a guide to help manufacturers request advice
from Expert Panels on clinical investigations and
development strategies for high-risk medical devices. This
procedure, designed for Class III and Class IIb active
devices, offers manufacturers the opportunity to consult
expert panels at different stages of the clinical
development process. The guidance includes detailed
instructions for submitting requests through a dedicated
portal, providing manufacturers with crucial support to
ensure safety and effectiveness. The process aims to foster
innovation and expedite patient access to high-quality
medical devices. More details are available on the EMA
website

The IMDRF Good Machine Learning Practice for
Medical Device Development: Guiding Principles
(IMDRF/AIML WG/N88 FINAL: 2025) offers a
comprehensive framework to ensure the safe and
effective use of AI and machine learning (ML) in
medical devices. This document, developed by the
Artificial Intelligence/Machine Learning-enabled
Working Group outlines 10 guiding principles aimed
at promoting robust AI integration across the entire
productlifecycle.

Key areas include the use of high-quality,representative
data, sound software engineering practices, and
ongoing post-market monitoring. The principles
emphasize transparency, risk management, and
collaboration, calling for international harmonization
and the development of consensus standards to
address the evolving landscape of AI in healthcare.
These guidelines are designed to balance innovation
with patient safety, helping manufacturers create
reliableandtrustworthyAI-poweredmedical solutions.

In January 2025, the Medical Device
Coordination Group (MDCG) endorsed two
key documents on the European Medical
Device Nomenclature (EMDN). MDCG
2025-2 provides a summary of 2024 EMDN
submissions and the outcome of its annual
revision. Additionally, MDCG 2024-2 rev.1
updates the procedures for EMDN
modifications, detailing the annual review
cycle and expedited update process
involving competent authorities, notified
bodies, and technical experts. These
updates reinforce regulatory transparency
and efficiency in the evolving EU medical
device landscape.

Medtronic has secured U.S. FDA approval for the Percept™ RC DBS system, the world’s first adaptive deep brain stimulation (aDBS) system for Parkinson’s disease. Unlike traditional DBS, this system adjusts stimulation in real-time based on patient-specific brain activity, enhancing treatment efficacy and reducing side effects.

The system uses BrainSense™ technology to continuously monitor brain signals, allowing for personalized therapy. This breakthrough in neuromodulation aims to improve symptom management for Parkinson’s patients. Medtronic’s latest innovation underscores its leadership in neurotechnology and commitment to advancing patient-centric, AI-driven therapies.

Philips has received the EU MDR certificate for its advanced imaging solution, ensuring compliance with the stringent European Medical Device Regulation (MDR 2017/745). The certification covers cutting-edge imaging technologies that support precise diagnosis and treatment planning across multiple clinical applications. Achieving MDR compliance is a key milestone, reinforcing Philips’ commitment to regulatory excellence and patient safety. This certification enables continued EU market access and strengthens Philips’ position as a leader in AI-powered and patient-focused imaging solutions. The company remains focused on driving innovation and compliance in medical imaging.

Health Canada has published new pre-market guidance for machine learning-enabled medical devices (MLMDs), outlining regulatory expectations for safety, efficacy, and transparency. The document provides a structured approach to MLMD classification, validation, and adaptive learning capabilities, ensuring robust performance across clinical use cases. It emphasises good machine learning practices (GMLP), data integrity, and change management strategies to maintain device safety. This initiative aligns with global efforts to standardise AI/ML-driven medical technologies while ensuring patient safety and innovation. Stakeholders are encouraged to review and align with the new regulatory framework.

Boston Scientific has received CE Mark approval for its next-generation Farapulse™ catheter and software, enhancing pulsed field ablation (PFA) for atrial fibrillation (AF) treatment. The upgraded system improves cardiac mapping and procedural efficiency, marking a significant step in electrophysiology. Additionally, the company successfully performed first clinical cases using the Faraflex™ catheter, a new PFA device designed for greater precision and maneuverability. These milestones reinforce Boston Scientific’s leadership in advancing safer, more effective AF treatment solutions.