Together with ABHI, we are excited to announce the Health Technology Regulatory and Innovation Programme, a joint initiative funded by Innovate UK that supports small- and medium-sized health technology companies to navigate the complex HealthTech regulatory processes.
The UK has a vibrant and rapidly growing HealthTech sector, supplying products from syringes and wound dressings to surgical robots and digitally enhanced technologies, and this funding programme will see many UK SMEs benefit from a share of £7m to help meet their regulatory needs.
Health technologies are highly regulated, with manufacturers needing to meet stringent requirements to sell goods into the UK, EU, US and other markets.
As the UK’s regulatory landscape for HealthTech is changing, manufacturers will need to prepare for a UK sovereign regulatory system, with the Medicines and Healthcare products Regulatory Agency (MHRA) currently consulting on the future regulation of medical devices and in-vitro diagnostics in the UK.
Added to this, companies looking to sell into the EU market now need to adhere to the new MDR, and the impending IVDR regulations, which may lead to some UK companies finding their products no longer meet the regulatory requirements to be sold within the EU…Read more