Life Sciences Horizons Brochure 2025 - Flipbook - Page 83
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2025 Horizons Life Sciences and Health Care
EU MDR/IVDR and U.S. FDA harmonization & global regulatory alignment
Medical device companies operating in both the
U.S. and Europe face increasing challenges due to
significant regulatory differences between the U.S.
Food and Drug Administration (FDA) and the European
Union’s Medical Device Regulation (MDR) & In Vitro
Diagnostic Regulation (IVDR). While FDA has long
maintained a structured and predictable framework
for medical device approval, the EU’s transition from
the older Medical Device Directive (MDD) and In Vitro
Diagnostic Directive (IVDD) to the MDR and IVDR has
introduced stricter clinical evidence requirements,
enhanced postmarket surveillance, and a more
complex CE marking process. These changes have
lengthened conformity assessment timelines and
created hurdles for manufacturers looking to maintain
market access in both regions, requiring greater
strategic planning and regulatory expertise to
navigate the evolving landscape.
To address these challenges, global regulatory bodies, including
the International Medical Device Regulators Forum (IMDRF), are
working toward harmonizing medical device regulations. The
goal is to reduce redundant compliance efforts, streamline
approval processes, and ensure that devices meeting high safety
and performance standards in one region can more easily gain
approval in another. However, despite progress, key differences
remain in classification, clinical evaluation requirements,
postmarket surveillance, and software regulations, making dual
compliance a costly and time-consuming endeavor for
manufacturers.
One of the biggest obstacles to harmonization is the
fundamental difference in regulatory oversight. FDA operates
as a centralized authority, reviewing and approving medical
devices through well-established pathways such as 510(k)
clearance, Premarket Approval (PMA), and De Novo classification.
In contrast, the EU system is decentralized, with more than 50
different Notified Bodies (NBs) designated by the competent
authorities of the EU Member States to conduct conformity
assessments for the CE marking of medical devices and IVDs.
The transition to these new regulations has tightened
requirements but also introduced delays and bottlenecks, as
Notified Bodies struggle with capacity constraints and varying
interpretations of compliance standards. Additionally, because
Notified Bodies are subject to surveillance by their designating
authorities, they tend to be risk-adverse in certification
decisions. Unlike FDA, they cannot provide strategic guidance
to manufacturers, such as advising on clinical strategy, making
their reviews less predictable. These factors contribute to
inconsistencies, prolonged approval times, and regulatory
uncertainty, further complicating market access for global
manufacturers.
Additionally, risk classification varies between the two systems.
While FDA categorizes devices into Class I, II, or III, the EU’s
MDR or IVDR has a more granular risk-based approach, dividing
devices into Class I, IIa, IIb, and III or Class A, B, C and D for the
IVDs. The EU has also imposed stricter clinical evidence
requirements, requiring manufacturers to provide robust
postmarket clinical follow-up (PMCF) data, which is a challenge
for companies used to FDA’s more flexible approach.
FDA has long imposed its own requirements related to quality
management system requirements under 21 CFR 820 which are
similar but not identical to the international requirements for
ISO13485. Both 21 CFR 820 and ISO 13485 focus on ensuring the
safety, effectiveness, and quality of medical devices throughout
their life cycle, emphasizing requirements for documentation,
risk management, design controls, and corrective actions. It is
not uncommon for companies to maintain two systems across
markets with some duplication of regulatory and compliance
processes, bringing with it complexity and compliance risk.
As a result of these key differences, another major concern is
cost. Compliance with two distinct regulatory frameworks
means higher costs and complexity for documentation,
clinical investigations, regulatory approval/CE marking,
Quality Management System operation and compliance,
and postmarket surveillance.
Recognizing the strain these discrepancies place on the industry,
FDA and EU regulators are actively collaborating through various
harmonization efforts. One key area of focus is greater mutual
recognition of regulatory data, which could help reduce the need
for duplicate clinical trials and redundant testing. This would be
particularly beneficial for devices incorporating artificial
intelligence (AI), Machine Learning (ML), and Software as a
Medical Device, where regulatory frameworks are still evolving
on both sides.
