The UK Medicines and Healthcare products Regulatory Agency (MHRA) plans to publish a public consultation on a proposal to allow medical devices automatic access to the UK market if they are authorized in a comparable regulator country (CRC) by the end of the year. Depending on the outcome of the consultation, the international reliance (IR) policy could be introduced as legislation in the British Parliament next year.
During a panel on international harmonization and reliance at the 2024 MedTech Conference hosted by AdvaMed, Rob Reid, deputy director for innovative devices at MHRA, updated attendees on a statement of policy intent published in May that proposed a high-level approach to allow devices in the UK market that have been authorized by CRCs, beginning with regulators in Australia, Canada, the EU, and US. (RELATED: MHRA proposes recognition path for devices cleared by trusted regulators, Regulatory Focus 21 May 2024)…
