How to ensure the safety and performance of vaginal rings

How to ensure the safety and performance of vaginal rings

Vaginal rings (VRs), also known as intravaginal rings (IVRs) are currently marketed mainly as contraceptive devices – contraceptive vaginal rings (CVRs) – as well as for hormone replacement purposes. These are primarily made from thermoplastic polymers or silicone elastomers.
Over the last few years there has been an increase in the research and development of VRs to be utilised as microbicide-releasing devices—vaginal drug delivery devices—requiring further assurances of safety and performance.
The growth of this technology brings together a need for standardized testing to ensure safety and confidence in their performance in order to meet regulatory requirements, including MHRA and FDA regulatory submissions.
There are currently no national or international standards for the mechanical testing of VRs, however we are seeing across the industry, testing to standards related to diaphragms being used to ensure minimum performance characteristics, including ISO 8009:2014 and ASTM D6976-13.

Why testing matters?

Characterization and verifying your product means you will have confidence in the raw material batch conformance, manufacture, shelf life and durability. All of these are crucial for the release of any new medical device product.

What about bespoke testing?

Where standard testing does not provide answers, Smithers' experts work with clients to develop bespoke tests to tackle device design concerns and gain a full insight into the performance of VRs.
These bespoke tests are then used to provide evidence of product conformity for regulatory submissions at the point of bringing the product to market.

Speak to our medical device testing experts today to discuss our vaginal drug delivery testing capabilities and broader support with medical devices.

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