UK:EU: MD Regulatory transition under Brexit

The HPRA is continuing to work with the European Commission and other Member States in relation to medical devices issues arising from Brexit.

HPRA Summary of Regulatory Requirements

Brexit: Medical Devices Planning

  • This HPRA presentation summarises the regulatory requirements for economic operators impacted by Brexit and addresses issues such as Device Certificates and Labels and Authorised Representative requirements. These requirements are applicable from 1 January 2021 when EU legislation will cease to apply to the UK.

  • The Great Britain route to market will continue to be based on the requirements of the Medical Devices Regulations 2002 which are derived from the former 93/42/EEC (MDD), 90/385/EEC (AIMDD) and 98/79/EC (IVDD). Changes in the legislation will take effect through Amendments.

  • From 1 January 2021, the MHRA will be able to designate UK Approved Bodies to conduct assessments against the relevant requirements for the purpose of a new UKCA mark.

  • The EU MDR and EU IVDR, will not be implemented in the UK.

  • Existing UK Notified Bodies with designations under the EU MDD, EU IVDD or EU AIMDD will have their designations rolled over automatically, without having to undergo a new designation process.

Northern Ireland Protocol: Impact on Medical Devices

  • In accordance with the Withdrawal Agreement, the Northern Ireland Protocol will apply from 1 January 2021. Under this Protocol, EU legislation including EU medical devices legislation will continue to apply in Northern Ireland only. This HPRA presentation summarises the key considerations of economic operators, including the potential impact on Irish distributors.

Source: European Commission

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