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11 August, MHRA

Following the UK’s decision to leave the EU, the MHRA is working with the government to determine the best options and opportunities for the safe and effective regulation of both medicines and medical devices in the UK. The MHRA stresses that it remains a priority to continue to participate in the European regulatory procedures for medicines. The current preparations to implement proposed new Regulations for Medical Devices and in vitro diagnostic (IVD) devices is continuing despite the recent exit vote. The MHRA will continue to engage widely with stakeholders to fully understand and maximise the opportunities of Brexit.

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Medicines and Healthcare products Regulatory Agency: MHRA and making a success of Brexit

11 August, MHRA

The Agency’s response to the outcome of the EU referendum.

Following the outcome of the EU referendum, the Medicines and Healthcare products Regulatory Agency (MHRA) is working closely with the Government to analyse the best options and opportunities available for the safe and effective regulation of medicines and medical devices in the UK.

While negotiations continue, the UK remains a full and active member of the EU, with all the rights and obligations of EU membership firmly in place. Working with our partners, stakeholders and customers, our focus remains: protecting health and improving lives.

Medicines regulation

Playing a full, active role in European regulatory procedures for medicines remains a priority. We contribute significantly in both the centralised and decentralised regulatory procedures, including new rapporteur and reference member state (RMS) appointments, and maintain our programmes for implementing EU legislation as required by our obligations as a Member State. We are also fully engaged in European and national scientific advice services and in delivering our EU inspection-related duties.

Devices regulation

Our role in regulating medical devices and in vitro diagnostic (IVD) devices remains integral. We oversee the essential work of the five UK Notified Bodies; together they are responsible for assessing the majority of devices currently placed on the EU market. Our preparations to implement proposed new Regulations for Medical Devices and IVDs continue.

Vigilance and market surveillance

We maintain our role in vigilance, market surveillance and taking direct action, where needed, to protect patients and public health, and we continue to co-ordinate with other Competent Authorities, across Europe and internationally, in these and other areas.

MHRA will be engaging widely with our stakeholders to fully understand and maximise the opportunities of Brexit.