There’s no question that the medical device market is global, and the United Kingdom (England, Scotland, Wales, and Northern Ireland) is one of the world’s most viable and vital markets. It’s certainly one that you want your medical device in if you hope to make a global impact. The Medicines and Healthcare products Regulatory Agency (MHRA) is the gatekeeper of that market and one of the world’s most influential regulatory bodies.
Knowing who the MHRA is and understanding their role in ensuring that only safe, effective, high-quality medical devices enter the market is vital to your success in the UK. In this brief article, we’ll tell you more about who the MHRA is, their authority and responsibilities, and even some of the requirements you must meet to get your medical device into this market.
The MHRA is an executive branch of the Department of Health and Social Care. It’s the UK’s equivalent of the US Food and Drug Administration (FDA), meaning that they set the quality and regulatory standards for medical devices in Great Britain.
Because the UK used to be part of the European Union, products required a CE marking to enter the UK market. Since Brexit, the MHRA has been the sole regulatory authority in Great Britain (England, Scotland, and Wales) and the gatekeeper to its robust medtech market.
As you know, medical devices must meet specific requirements before they can be sold in most markets around the world. Generally, the more developed the nation and its healthcare and medical device industries, the more complex its healthcare regulations are.
The MHRA is responsible for:
Registering a medical device in the UK is different than in years past due to Brexit, which was the British exit from the European Union. Before Brexit, the UK adhered to the EU regulatory requirements as put forth in the EU MDD/IVDD, which Regulation EU 2017/745 (MDR) and Regulation EU 2017/746 (IVDR) eventually replaced. However, the MHRA will be instituting its new regulations currently set to be in force in July 2024.
One of the first steps of registering a product in the UK is getting the UK Conformity Assessment (UKCA) marking on your device and packaging. Manufacturers of Class I (lowest-risk classification) devices and general In Vitro diagnostic devices can self-certify against UKCA marking if these devices are non-measuring and non-sterile.
Class II and III devices must go through conformity assessment by a UK approved body. Approved bodies are the UK’s equivalent of Notified Bodies in the EU. These organizations have the authority to perform conformity assessments and apply UKCA markings on medical devices. UK approved bodies also perform post-market surveillance of devices currently on the market to ensure they’re safe and compliant for as long as they’re in use.
The process is a little different for device manufacturers outside of the UK who want to market their medical devices. Foreign manufacturers must designate a single person based in the UK to serve as their authorized representative (or UK Responsible Person). The UK Responsible Person acts as a liaison between the manufacturer and the relevant approved regulatory bodies, and handles the task of registering that company’s products with the MHRA.
When registering a device in Great Britain and Northern Ireland, you’ll notice that there are different procedures even though both were part of Brexit. According to the Northern Ireland Protocol (Northern Ireland’s response to Brexit), Northern Ireland applies Regulation EU 2017/745 (MDR) and Regulation EU 2017/746 (IVDR) to its own regulatory framework, whereas Great Britain has decided to implement its own regulations over the next couple of years.
For instance, as Northern Ireland still adheres closely to Regulation EU 2017/745 (MDR) and Regulation EU 2017/746 (IVDR), UK approved bodies cannot provide conformity assessments for them. In fact, if a manufacturer based in Great Britain wants to put a medical device on the market in Northern Ireland, they must designate an EU Authorized Representative to register the product for them.
Furthermore, an EU Notified Body must provide a conformity assessment according to Regulation EU 2017/745 (MDR) and Regulation EU 2017/746 (IVDR) for the device to receive UKNI marking (Northern Ireland’s conformity assessment mark). Likewise, Northern Ireland Authorized Representatives cannot represent Northern Irish or other foreign manufacturers in Great Britain, nor can Northern Ireland Notified Bodies provide UKCA marking for medical devices. In short, Northern Ireland has decided to continue to abide by EU medical device and in vitro diagnostics regulations as set forth by the European Medicines Agency, whereas Great Britain has not.
The MHRA is firmly positioned as one of the foremost regulatory authorities in the world. They’re responsible for creating, implementing, and enforcing regulations for medical devices and IVDs in the UK while also providing research and education to promote the safety and efficacy of devices worldwide.
Adherence to UK regulations is essential to getting your medical device on that market and keeping it there. Medical devices entering the Great Britain market must adhere to the MDR/IVDR (until June 30, 2023) or UK MDR 2002, whereas Northern Ireland still abides by EU regulations.
Manufacturers based outside of Great Britain that want to put their devices on the market there must designate a UK Responsible Person (UKRP) to represent their interests and a UK-approved body to perform conformity assessments and apply UKCA marks. At the same time, Northern Ireland still adheres to EU regulations, requiring foreign manufacturers to utilize EU and NI responsible persons and notified bodies to assess medical devices, documentation, and manufacturing facilities while requiring the EU’s CE marking.
Bringing your device to market in the UK requires a dynamic regulatory strategy that enables you to optimize your projects and processes, ensuring your medical devices hit the mark for both the GB and NI markets. Also, it’s vital that you do your due diligence to ensure conformity with the regulations of both markets while also avoiding conflating their processes and regulatory requirements. Ultimately, getting your medical devices compliant with both markets could set your medtech company up to be a mainstay in the UK.