January 6, 2021
Following its recent departure from the EU, the UK has introduced a new medical device information system (MDIS) that requires all medical devices available on the UK market to be registered with the Medicines and Healthcare products Regulatory Agency (MHRA) using official global medical device nomenclature (GMDN).
The new system came into effect on 1 January 2021, with certain devices allowed a...
February 7, 2019
The Association of British HealthTech Industries (ABHI) has reassured its members that a UK product safety mark to replace the CE mark in the event of a no-deal Brexit will not apply to medical devices.
In the UK, all medical devices are subject to EU legislation, which requires manufacturers to place CE marks on their products to show compliance to applicable standards.
Earlier this week, the...
June 27, 2016
The UK’s unexpected referendum vote to leave the EU last week likely won’t take effect for another two years at least, but the potential consequences of the decision are already generating discussions in every industry, and digital health is no exception.
Today the European Connected Health Alliance (ECHAlliance), a Belfast, Northern Ireland-based nonprofit collaborative with a mission to “...