In what is referred to as “Brexit,” The UK has been officially out of the EU for more than two years. This led to a lack of clarity in the medical device sector. On the appropriate UK regulations under an EU-less scenario. The MHRA became the only Essential Medical Device regulator in the United Kingdom on January 1, 2021. (There remains a market authorization via European procedure for Northern Ireland, as part of the UK).
The UK Medicines and Medical Devices Act (MMDA, 2021) went into effect on February 11, 2021. And one of its provisions allowed for the modification of the UK Medical Device Regulations 2002. The legal actions are necessary to put the previous EU Directives for medical devices, and active implants. And IVDs into effect are contained in these regulations.
The MHRA consulted on a suggested regulatory framework for medical devices in the fall of 2021. To get input from businesses, patients, and health advocacy organizations. And other stakeholders, a paper with 17 chapters covering the whole range of regulatory topics was made public. On November 25, 2021, the consultation came to an end with around 900 replies from people and groups.
After the UK government reviewed the stakeholder comments. The MHRA delivered an official response to the consultation on June 26, 2022.
When It Makes Sense, Align to the EU
It is hardly surprising that the new UK legislation will closely resemble those put in place through the MDR. And IVDR given the country’s tight economic links to the EU. The MHRA will consult the global community for best practices when doing so will benefit the UK. Such as when it comes to more closely following the IVD classification guidelines established by the IMDRF (International Medical Device Regulators Forum). An interesting Appendix to this paper from Latham & Watkins. LLP relates several features of UK laws to the MDR and IVDR.
Strengthening Patient Safety Regulations
The objective of putting patient safety first will be advanced by modernizing the following things. These consist of:
Modifications to the product classification methodology to upgrade a range of devices. Including some implantable like surgical mesh, and extending the regulatory reach to target non-device items. With risk profiles comparable to those of medical devices, such as dermal fillers.
Strengthening post-marketing procedures would improve reporting and surveillance and be more in line with EU regulations.
UDIs and a registration database are being implemented for better traceability.
The UK will be better aligned with the EU and other international regulators. Who is placing an enhanced focus on medical device safety thanks to these measures? Which will help increase public confidence in medical devices placed on the market.
Access to Medical Devices is improved
The UK has acknowledged the significance of giving manufacturers more choices and freedom when selling their products there. Without sacrificing the emphasis on safety, relying on already-issued permits from other jurisdictions can assist in quicker market access. For instance, companies that have certificates from the Medical Device Single Audit Program (MDSAP) can use customized routes to market.
In addition, through a procedure called Domestic Assurance. Approvals from specific nations can be used to expedite the examination of the device assessment. Additionally, the UK plans to establish a pre-approval path for items under specific conditions to expedite the introduction of innovative products.