The UK Conformity Assessed (UKCA) marking is the new legally required product marking for goods being placed on the market in Great Britain from January 2021, covering most products that previously required a CE mark. While similar to the EU’s CE marking requirements, the UKCA means many must relearn the necessary requirements for medical device manufacturing.
CE marking is a self-declaration where a company demonstrates conformity with EU health, safety, and environmental regulations and affirms that a product meets essential standards. Similarly, UKCA marking demonstrates conformity with UK regulations. For medical devices intended for Great Britain’s market, a UKCA is needed. Currently, Great Britain is allowing a transitional period until 2023 for businesses to switch to UKCA.
What do you need to do to place a medical device on the Great Britain, Northern Ireland and European Union (EU) markets?
The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating the UK medical devices market.
This guidance provides information on the UK system, including for:
- getting your device certified
- conformity marking your device
- registering your device with the MHRA
The guidance is divided into sections on the different rules that apply in Great Britain, Northern Ireland and the EU. Great Britain is England, Wales and Scotland.
Powers in the Medicines and Medical Devices Act (2021) allow the UK government to amend the Medical Devices Regulations 2002 which govern medical devices regulation in the UK. Amendments to create the new regime are scheduled to be in force at the beginning of July 2023 to align with the date from which we are due to stop accepting CE marked medical devices in Great Britain and will require the use of the UKCA marking.
The scope of this consultation has been informed by early engagement with a range of stakeholders and it sets a series of proposals which can help us make the UK the most attractive place to research, develop, produce, and supply safe and innovative medical devices.
Realising opportunities for safe and innovative devices – across the UK
The governments purpose is clear: To protect and improve patient health by enabling the earliest access to, and high-quality supply of, safe, effective and innovative medical products through proportionate, data-driven assessment of risks and benefits. Over recent years patients and patient groups have emphasised the importance of patient safety, and the recent Independent Medicines and Medical Devices Safety Review, led by Baroness Cumberlege, reinforces that maintaining this focus is paramount.
The regulatory environment will also need to support the Government’s ambition to be at the forefront of medical device innovation and adoption. In many areas, gaining and maintaining competitiveness in a global market will be best supported by alignment with internationally recognised best practice and standards.
Patient safety and innovation are not mutually exclusive, and we want to ensure that our regulations maximise both. With this bold new regulatory regime, we will propel our medical devices sector forward in several significant areas through:
creating new access pathways to support innovations, which will ensure the UK remains an excellent place to launch new medical devices and avoid repeat assessments, granting early patient access to novel treatments whilst maintaining robust safety standards and capitalising further on our global reputation for R&D and the NHS; a unique, innovative, and ambitious framework for regulating software and artificial intelligence as medical devices. This leading regulatory model will address many challenges ahead of international peers, ensuring that we attract a world-class life sciences industry and innovators without compromising on safety; reforming in vitro diagnostics (IVD) regulation to update classification and include an extended patient risk review, recognising the central role that diagnostic devices have played in our response to the Covid-19 pandemic; becoming a sustainability pioneer through the safe re-use and re-manufacture of medical devices, offering a substantial opportunity to reduce single-use medical devices, help reach the Government’s Net Zero target, support the Greener NHS Initiative, and improve supply chain resilience.
The new regulatory framework will be designed to boost patient safety and support the continued growth of the MedTech and diagnostics sector across the whole of the UK. It should be noted that the Government is seeking to find a new balance in the Northern Ireland Protocol whereby UK rules may apply as set out in its recent Command Paper “Northern Ireland protocol: the way forward.”
Timing of legislation
The Regulations will come into force on 1 July 2023 with appropriate transitional arrangements. The government believe these timescales will deliver benefits at pace, whilst providing industry time to adapt to meet the requirements in future regulations.
In making changes to the regulatory framework for medical devices, the Medicines and Healthcare products Regulatory Agency (MHRA) will ensure that we use both regulations and guidance to establish a fluid and effective approach to the oversight of medical devices and technologies. In some cases, this is likely to involve greater use of guidance than under the existing regulatory framework to ensure that the UK can keep pace with dynamic innovation in medical technologies, whilst maintaining high standards of patient safety.
Summary of key requirements for placing a device on the Great Britain market
Since 1 January 2021, there have been a number of changes, introduced through secondary legislation, to how medical devices are placed on the market in Great Britain (England, Wales and Scotland). These are:
- a new route to market and product marking (the UKCA marking) is available for manufacturers wishing to place medical devices on the Great Britain market
- all medical devices, including in vitro diagnostic medical devices (IVDs), custom-made devices and systems or procedure packs, need to be registered with the MHRA before they are placed on the Great Britain market
- if you are a medical device manufacturer based outside the UK and wish to place a device on the Great Britain market, you need to appoint a single UK Responsible Person for all of your devices, who will act on your behalf to carry out specified tasks, such as registration. Further detail on the UK Responsible Person is set out below
- CE marking will continue to be recognised in Great Britain until 30 June 2023
- certificates issued by EU-recognised Notified Bodies will continue to be valid for the Great Britain market until 30 June 2023
- the EU no longer recognises UK Notified Bodies
- UK Notified Bodies are not able to issue CE certificates - and have become UK Approved Bodies