BREXIT: What if the Devices Are Not Yet Registered with the UK MHRA?

The Brexit has been in effect from January 01, 2021, impacting every bilateral aspect between the European Union (EU) and the United Kingdom (UK). There have been new regulations in place for the citizens as well as the stakeholders from various industries. The new medical device regulations released by the UK MHRA also have come into effect from January 01, 2021. The UK MHRA had provided certain extended grace periods for different device classes based on the risk and their registrations.

The first and second grace periods (April 30, 2021, and August 31, 2021, respectively) ended for Active implantable medical devices, Class III medical devices, Class IIB implantable medical devices, IVD List A products, Class IIB non-implantable medical devices, Class IIA medical devices, IVD list B products, and self-test IVDs. After these timelines, the device manufacturers placing their products in the UK market must comply with regulations and cannot place the product on the UK market without registration with the MHRA. Where applicable, they should obtain UKCA marking issued by the MHRA-accredited Assessment Bodies, and the manufacturers already exporting their devices to the UK shall appoint a United Kingdom Responsible Person (UKRP) before these timelines.

Now the main question is, what if the manufacturers could not appoint a UKRP due to certain unavoidable reasons? What should be the immediate action plan for the device manufacturers to ensure compliance and avoid possible repercussions of non-compliance? If you haven’t yet appointed a UKRP by the past deadlines, then here’s what you can do:

Request MHRA for an Extended Timeline

If the manufacturer did not meet the deadlines for any valid reason, they might submit their case to the UK MHRA. The MHRA would review the case and allow an extended timeline, provided the reason is valid. The manufacturer should then register within the extended timeline provided by the MHRA. The grant of extended timeline is within the discretion of the UK MHRA and the Agency is not obliged to necessarily act upon a request being submitted by the manufacturer.

Start your Journey Towards Compliance by Appointing a Reliable UKRP

Non-UK manufacturers who haven’t met the deadline and want to register their products with the UK MHRA should start appointing a UKRP soon. It is a mandatory requirement of the UK MHRA. The UKRP can help the manufacturers to get their products registered with the MHRA.

Register Your Products with MHRA

As the deadline is already crossed, the manufacturers must have a strategy to get their products registered with the MHRA as soon as possible to continue to market or sell their products in the UK.

Reach out to an Expert Consultant/Regulatory Service Provider/MHRA for Advice

In cases where manufacturers have crossed the deadline, it would be ideal for reaching out to an expert consultant or a global Regulatory service provider. Service providers deliver many such projects and would have handled varied scenarios for device manufacturers. They have expertise in registering with the MHRA within a quick turnaround time. Alternatively, manufacturers may also write to the MHRA for quick assistance.

To appoint a UKRP or get your devices registered with UK MHRA, start now with expert consultation.



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