Please see this new BMJ article with these key messages:
The rapid growth of the molecular diagnostics sector has prompted concerns about major gaps in the regulatory regime for diagnostic devices;
Many molecular diagnostics are laboratory developed tests, which are currently not tracked or subject to evaluation under medical device regulation;
Risk classification systems for diagnostic devices mean that even in the regulated part of the market tests may not be subject to premarket review;
Regulatory responses to these gaps have been mixed, but EU regulations hold the greatest potential for real improvement.
Holloway BMJ 2019.pdf (864.1 KB)