On 22nd November, MHRA hosted a workshop looking at orphan devices. Paul Fisher attended for BIVDA.
Paul said “It’s encouraging to see the MHRA recognising this issue and working with industry to resolve it. Low demand for orphan devices, including IVDs means manufacturers need to be supported to continue to develop and supply these vital tests.
“BIVDA set out our position – there should be a clear acceptance of international certification, including the pooling of data from other regulators, and a shift in focus to post-market surveillance to regulate orphan IVDs and support manufacturers in developing these products. In the short term, clearer guidance from the MHRA, acceptance of in-silico data, and use of the humanitarian provision should allow orphan IVDs to continue to be supplied.”