Life Sciences Horizons Brochure 2025 - Flipbook - Page 84
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2025 Horizons Life Sciences and Health Care
EU MDR/IVDR and U.S. FDA harmonization & global regulatory alignment
(continued)
Another major initiative is the alignment of Unique Device
Identification (UDI) systems, which aim to improve global
tracking of medical devices. The EU’s new EUDAMED
database, which consolidates device registration, vigilance
reporting, and market surveillance data, is being developed
with interoperability in mind. Efforts are underway to
harmonize it with FDA’s Global Unique Device Identification
Database (GUDID), allowing for a more seamless global
tracking system.
Looking ahead, industry experts anticipate further
regulatory alignment through IMDRF initiatives. There is
growing momentum for the use of Real-World Evidence
(RWE) in regulatory decision-making, which could help
streamline approval processes across jurisdictions.
Additionally, discussions on potential Mutual Recognition
Agreements (MRAs) could, in the future, lead to partial
acceptance of FDA and EU regulatory approvals, easing the
burden on manufacturers.
FDA is moving toward harmonization is quality system
requirements with ISO 13485, which will help manufacturers
simplify compliance efforts across markets, reduce
duplication of regulatory processes, and improve the overall
quality of medical devices globally. This alignment promotes
greater consistency in industry practices and eases market
entry for medical devices across different jurisdictions.
Another expected development is the participation of the
EU to the MDSAP program, expansion of third-party review
and remote audits, which could reduce the redundancy in
regulatory inspections and compliance reviews. Companies
will also need to closely monitor changes in AI/ML
regulations, as both FDA and EU are developing frameworks
for adaptive algorithms and digital health technologies.
Moreover, postmarket surveillance regulations are being
reviewed with the aim of standardizing adverse event
reporting. The Global Medical Device Nomenclature
(GMDN) is being adopted by both regions to create a
common language for device and event classification,
improving communication and consistency in safety
monitoring.
While complete harmonization between FDA and EU MDR/
IVDR remains a long-term goal, ongoing efforts signal a shift
toward greater alignment, benefiting both regulators and
manufacturers. For companies navigating this landscape,
staying ahead of regulatory updates and adopting a
proactive compliance strategy will be essential for
global market success.
Fabien Roy
Partner
Brussels
Jodi Scott
Partner
Washington, D.C.
Band 1
Life Sciences &
Pharmaceutical Sector
International & CrossBorder in Chambers
Global, 2025
