A defibrillator is a medical device designed to treat people experiencing Sudden Cardiac Arrest (SCA). There are many regulations in place to govern how medical device manufacturers are able to produce and supply their products.
Regulation of medical devices in Great Britain (England, Wales and Scotland)
New changes have been introduced through secondary legislation as to how medical devices are placed on the market in Great Britain. The UK MDR 2002 was amended with new requirements in 2019 and 2020. These include:
- UKCA marking is available for all manufacturers who wish to place medical devices on the Great Britain market
- All medical devices need to be registered with the MHRA before they are placed on the Great Britain market
- CE marking will continue to be recognised in Great Britain until June 2023
- The new UKCA marking will replace CE marking after June 30, 2023
What is the MHRA (Medicines and Healthcare products Regulatory Agency)?
The Medicines and Healthcare products Regulatory Agency is responsible for regulating the UK medical devices market. As an executive agency of the Department of Health and Social Care in the United Kingdom, the MHRA is responsible for ensuring that medicines and medical devices work and are acceptably safe.
What is the difference between CE and UKCA?
CE marking is a self-declaration where a manufacturer proves compliance with EU health, safety and environmental protection legislation and confirms a product's compliance with relevant requirements. UKCA marking proves compliance with UK legislation.
CE marked defibrillators will continue to be accepted on the Great Britain market until 30 June 2023. From 1st July 2023, devices that are placed on the Great Britain market will need to conform with UKCA marking requirements.
The UKCA marking is not recognised in the EU, EEA or Northern Ireland markets, so relevant products require a CE marking for sale in these markets.
Regulation of medical devices in Northern Ireland and Europe
Under the terms of the Northern Ireland Protocol, the rules for placing medical devices in Northern Ireland are different from those that apply to Great Britain.
Northern Ireland follows EU MDR requirements although it is part of the United Kingdom. The EU MDR applies in Northern Ireland as it shares a critical land border with Ireland which is an EU member state. CE marking is required for the Northern Ireland market and EU rules must be met.
The UKCA marking is not recognised in the EU market. A CE mark is required to show compliance with EU legislation. The EU MDR is intended to ensure a high standard of quality and safety for medical devices being produced in or supplied into the European market.
What is the EU MDR (Medical Device Regulation)?
The MDR is the set of rules and regulations that governs the production and distribution of medical devices in Europe. Since 26 May 2021, the EU Medical Devices Regulation (Regulation 2017/745) (EU MDR) has applied in EU Member States and Northern Ireland.
Companies who wish to market or sell their products in the EEA (European Economic Area) must comply with this regulation. Aligned closely with the FDA regulations, it is intended to improve the quality, safety and reliability of medical devices placed on the European market.
What is the FDA?
Similar to the MHRA in the UK, the FDA (Food and Drug Administration) of the United States of America is the medical regulatory body in the USA and is responsible for the licensing of medications depending on the results of clinical trials.
FDA approval always requires a bespoke clinical trial whereas a CE mark can be obtained following utilisation and application of successful clinical evaluations of equivalent pre-existing devices and a subsequent post-market study.
The CE mark process requires proof of the safety of the device usage but tends to be faster and cheaper than obtaining FDA approval. FDA approved AEDs are devices that have been approved by The Food and Drug Administration and have met strict quality standards to pass the premarket approval application submitted to the FDA. This means that FDA approved devices have undergone further safety and security to ensure efficiency in an emergency situation. Defibrillators that are non-FDA-approved are no less capable of saving a life but are not allowed to be placed on the US market.
All defibrillators undergo tests and are marked accordingly to comply with the legislation relevant to the market they are intended to be placed on.
More Information
For more information on the topics discussed within this article, please visit the following resources:
https://www.gov.uk/guidance/regulating-medical-devices-in-the-uk
For more information or advice on topics surrounding defibrillators and Sudden Cardiac Arrest, visit our Resource Centre or get in touch with a member of the team.
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