Challenges

Although the product was a seemingly simple hyaluronic acid eye drop, its substance-based nature, ocular route of administration, and use of animal-derived components resulted in significantly different regulatory classifications across global markets.

Under EU MDR Rule 21 for substance-based medical devices, the product was classified as a Class IIb medical device due to absorption through ocular tissues, long-term use classification under ISO10993, triggering increased clinical, Notified Body, and post-market surveillance requirements. Globally, the same product faced divergent outcomes:

– EU: Class IIb Substance-Based Medical Device
– Canada: Class II Medical Device
– Australia: Class III Medical Device
– USA: OTC Drug

This divergence created challenges related to development timelines, evidence requirements, and labeling consistency.

Solutions

We implemented a harmonized global regulatory strategy built around the highest-risk classification. Key actions included:

– Development of a robust Rule 21 substance-based classification rationale under EU MDR
– Proactive management of animal-derived material and OEM risks
– Strategic reuse of clinical and safety evidence across jurisdictions
– Alignment of claims and labeling to support both medical device and OTC drug frameworks

Results

  • Successful EU MDR conformity assessment as a Class IIb substance-based medical device including EU-MDR QMS upgrade
  • Efficient approvals in Canada (Class II)
  • Seamless entry into the US OTC drug pathway without reformulation
  • Reduced overall time to market through a coordinated global approach

Conclusion

This case study demonstrates how substance-based products, even when technologically simple, can face highly divergent regulatory pathways worldwide. By anticipating classification impacts early and aligning regulatory strategy across regions, the client successfully navigated complex and differing frameworks—bringing their product to market efficiently and compliantly.
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