The Medical Device Single Audit Program (MDSAP) pilot was initiated this year, promising medical device companies the potential to enter multiple markets without having to go through multiple audits of their quality management systems (QMS).
With the pilot scheme coming to an end, with plans to be fully implemented next year, manufacturers will be wondering whether the program is ready. Despite a compelling value proposition for both regulators and manufacturers, MDSAP has gained underwhelming traction so far.
Manufacturer buy-ins and insufficient cost-benefit tradeoffs seem to be causes for concern, resulting in the slower uptake of the MDSAP. Other external factors such as the European Medical Device Regulations and In Vitro Diagnostic Regulations come into play as well.
More time may be necessary in order to address these issues to ensure a better integration rate of the MDSAP programme.