When medical devices and software products are created, all parties involved must have a firm understanding of compliance regulations, conformity marking and classification types, to ensure that the development process aligns with the highest standards of safety, efficacy, and quality.
Unfortunately, recent and proposed changes to these regulations following the UK’s exit from the EU, make it increasingly difficult to source the most relevant and reliable information. Some documents have undergone changes and adaptations, while others refer to existing literature.
To help guide you through the process, we’re sharing some of the most up-to-date resources so that you know how to meet the necessary criteria prior to embarking on a MedTech software development project.
What constitutes a medical device?
According to the MHRA, “A manufacturer’s stated view of their product is not solely determinative as to whether their device is or is not a medical device”. Therefore, before undertaking any medical software development project, it’s vital that you are aware of the current medical device definitions and criteria that you may need to adhere to.
Classifying a product or service as SaMD
Gaining a comprehensive understanding of SaMD is crucial as the regulations governing SaMD in the UK are presently undergoing reform to better align with IMDRF (International Medical Device Regulators) guidelines and terminology. The MHRA has also publicised the fact that they will be introducing a medical device change programme.
Currently, the existing medical device regulations have limited provisions specifically designed for the regulation of SaMD, however, this is shifting in a bid to improve the safety of patients and to enhance clarity for healthcare practitioners and manufacturers alike.
More information regarding these changes can be found in the following report: Government response to consultation on the future regulation of medical devices in the United Kingdom.
The MHRA’s proposed roadmap can also be found here: Software and AI as a Medical Device Change Programme
To provide clarity on what constitutes SaMD, The IMDRF provide the following definition:
“The term “Software as a Medical Device” (SaMD) is defined as software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.”
According to The IMDRF, a medical device refers to:
“...any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings, for one or more of the specific medical purpose(s) of:
• diagnosis, prevention, monitoring, treatment or alleviation of disease,
• diagnosis, monitoring, treatment, alleviation of or compensation for an injury,
• investigation, replacement, modification, or support of the anatomy or of a physiological process,
• supporting or sustaining life,
• control of conception,
• disinfection of medical devices,
• providing information by means of in vitro examination of specimens derived from the human body; and does not achieve its primary intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its intended function by such means.”
The IMDRF provides further guidance on the criteria and conditions of this definition within section 5 of their document Software as a Medical Device (SaMD): Key Definitions from which the above information is taken.
UK MDR
To ascertain the legal classification of your product or service as SaMD, it is essential that your software explicitly declares a medical purpose as outlined in the UK Medical Devices Regulations (UK MDR) 2002.
The UK MDR came into effect on January 1, 2021, after Brexit, and replaced the EU regulations for medical devices in Great Britain. It outlines the regulatory requirements for medical devices in the UK and aligns with international standards, including ISO 13485.
Following this change, it is now a requirement to register all medical devices intended for the Great British market (England, Scotland, Wales) with the Medicines and Healthcare Products Regulatory Agency (MHRA).
What is MDSW?
The term MDSW is used solely within the EU to refer to “Software that is intended to be used, alone or in combination, for a purpose as specified in the definition of a “medical device” in the Medical Devices Regulation (MDR) or In Vitro Diagnostic Medical Devices Regulation (IVDR).” - European Commission (2021).
Unlike SaMD, which is used to refer to non-integrated stand-alone software, MDSW encompasses a broader range of medical software, whether operating independently or embedded into hardware, as long as it serves a purpose outlined in the definitions of a "medical device" in the EU MDR or In Vitro Diagnostic Medical Devices Regulation (IVDR).
It's crucial to note that MDSW regulations are not applicable within the UK. However, if your product is intended for use outside of Great Britain, a comprehensive understanding of both the UK regulatory framework and the EU regulations becomes essential.
CE Marking Vs UKCA Marking
Both CE and UKCA markings serve as indicators of compliance with regulatory requirements, ensuring that healthcare products and devices meet specified safety, health, and environmental standards.
Before 2021, CE Marking was the standard for products sold in both the UK and the European Union (EU). However, following the UK's exit from the EU, UKCA marking was introduced for UK market products. This UKCA marking is not recognised in the EU, EEA or Northern Ireland markets, therefore relevant products will require a CE marking for sale in these markets.
According to the MHRA, manufacturers of medical devices carrying the CE mark and adhering to the EU Medical Devices Directive (EU MDD) or the EU Active Implantable Medical Devices Directive (EU AIMDD) are granted until June 30, 2028, to introduce their products to the British market.
This deadline extends to June 30, 2030, for in vitro diagnostic medical devices. For more information, please see the following page on CE Marking recognition published by the UK Government website.
UKCA Mark Requirements
The UKCA mark requirements for medical devices are determined by the three main categories and their respective sections in the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002):
- General medical devices: Covered by Part II of the UK MDR 2002
- Active implantable medical devices: Addressed in Part III of the UK MDR 2002
- In vitro diagnostic medical devices (IVDs): Regulated under Part IV of the UK MDR 2002
To ensure compliance with the UK MDR 2002, you must demonstrate that your medical device meets the stipulated requirements through a conformity assessment. The specific assessment route is contingent on the device's classification. Upon successfully completing the conformity assessment, you can affix the UKCA mark to your product, signifying that the medical device has met the necessary requirements.
Classifying Medical Devices
Device classification is based upon factors such as the intended use, duration of use, invasiveness, and the impact on the patient if the device were to fail.
Under both CE and UKCA, there are four classes that medical devices can be categorised by (I, IIa, IIb and III). Devices that fall under Class I are sold on a self-declaration basis.
For higher-risk devices, an assessment must be carried out by notified bodies prior to distribution. The same applies for IVDs.
Here is a breakdown of the classifications:
- Class I: Devices with the lowest risk.
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- Class IIa: Devices with a higher level of risk than Class I but still a moderate risk.
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- Class IIb: Devices with a higher level of risk than Class IIa.
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- Class III: Devices with the highest level of risk.
To help with the classification of your software, please refer to the Annex IX of Directive 93/42 as advised in section 7 of The Medical Devices Regulations 2002 (Part II).
Along with meeting the necessary requirements outlined within the MDR 2002, you need to evidence that the device is safe and effective for its intended use by demonstrating awareness of risk and displaying effective mitigation measures through proper risk management.
Impending Changes to Medical Device Regulations
Given the UK government and the MHRA’s commitment to implementing new guidance and secondary legislation for both medical software and AI, it is important to regularly check the official MHRA page on the government website for any updates, changes, or potential amendments to timelines.
It was anticipated that many of these changes would have come into effect earlier this year (2023) however extensions have already been put in place.
Getting Support
At Newicon, we have first-hand experience developing digital products for the healthcare market.
This means that we’re able to offer ongoing support throughout your development journey to ensure that your product meets all of the necessary regulatory benchmarks and quality standards.
If you’d like to start a conversation about MedTech, don’t hesitate to get in touch.
Want to find out more about some of the exciting medical innovation projects that we’ve worked on?
Learn about our involvement with The Product Partnership to create the groundbreaking communication technology Earswitch, or check out this interview with Anne Hegmann-Weston from SehaMed to discover how we helped them develop their revolutionary 3-in-1 MedTech platform.