Medical & Healthcare Regulation
Medical and healthcare regulation can feel like a minefield for businesses to navigate, particularly given the dual regulatory regimes arising for medical and healthcare products as a result of Brexit.
Whether you need support and guidance to understand the complex regulatory requirements necessary to put medical devices on the market, representation at an inquest, help registering with the Care Quality Commission, or advice on how to challenge correspondence from regulators alleging breaches of your legal obligations, our specialist team are here to help.
Our experience includes:
- helping clients to place compliant medical devices and in vitro medical devices on the market in the UK / EU
- advising clients about the changing regulatory landscape of medical devices/in vitro medical devices as a result of Brexit including how to benefit from transition periods and ensure compliance with differing requirements when transition periods end
- identifying legal obligations placed on various economic operators in complex supply chains
- providing advice on importing / exporting medical devices into and out of the UK
- conducting / supporting internal investigations when things go wrong
- liaising with regulators on behalf of our clients including the police, CQC, MHRA and HSE – and challenging regulatory interventions, where appropriate
- advising on licensing requirements for pharmacies and the possession / supply of controlled drugs
- helping clients to obtain and maintain relevant CQC registrations
- representing numerous clients in the pharmaceutical and healthcare sectors during inquest proceedings to manage reputational risks and potential future civil claims.
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