The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a statement on their role in the regulation of medicines and medical devices throughout the Brexit negotiations. They state that their role in regulating medical devices and in vitro diagnostic (IVD) devices “remains integral”. Currently, the MHRA oversee the essential work of the five UK Notified Bodies which are responsible for assessing the majority of devices currently placed on the EU market. The statement also confirmed that preparations to implement proposed new Regulations for Medical Devices and IVDs continue.
On medicines, the MHRA is still playing a full, active role in European regulatory procedures and in vigilance and market surveillance. They are still taking direct action, where needed, to protect patients and public health, and continue to co-ordinate with other Competent Authorities, across Europe and internationally, in these and other areas.
The MHRA did, however, reference the recent notices to Marketing Authorisation (MA) Holders issued by the EMA/EU-27 and CMDh, which described the preparations that MA holders may want to consider ahead of the UK’s exit from the EU. It was advised that if, MA Holders do not want to consider preparation for any potential changes to marketing authorisation or Reference Member State, then they should refer to the information provided by the EMA and the HMA on this matter.
Regardless of the outcome of the next round of Brexit negotiations, the MHRA will continue to collaborate with all involved to deliver the current speed of authorisations, access to new and innovative medicines and devices and to continue to ensure the quality, safety and efficacy of all medicines and devices, to safeguard an uninterrupted level of public health protection.