29 October 2021
Download – 'Femtech' and issues around digital health products – 4 of 5 Insights
The term 'femtech' is often, and somewhat controversially, used to describe the intersection between technology and the health and wellbeing largely of people assigned female at birth. Innovative technology geared at women's wellbeing and health has seen an uptick in recent years with the development of apps, digital platforms and other products delivering female-focussed solutions for women's biological and mental health needs. These technologies can apply to various aspects of women's lives such as fertility, pregnancy, contraception, menstruation, childbirth, breastfeeding and menopause, as well as diseases that have a greater prevalence in people assigned female at birth.
A range of laws regulate these technologies in the UK. As there is no one size fits all approach, each product requires careful and detailed assessment on a case-by-case basis. In some cases, technologies can be products that may qualify as medical devices or deliver services that are regulated as healthcare in the UK, which can pose challenges navigating complex regulations.
Consequently, a critical part of developing and launching new products and services in this innovative space will be understanding the regulatory framework. Getting it wrong can mean delays to launch dates. If the product or service has already been launched without sorting out regulatory requirements, it could attract enforcement action leading to damage to a company's reputation and reduction in investor confidence.
In this article, we do not consider every regulation that might apply to these products or services but outline some points to consider under medical device and healthcare law.
Following Brexit, the UK is essentially two jurisdictions when it comes to the regulation of medical devices – Great Britain (England, Scotland and Wales) and Northern Ireland; the latter remains aligned with the EU regulatory framework. However, in both jurisdictions, the route to market for medical devices will depend on their type (general medical devices, active implantable medical devices or in vitro diagnostic medical devices), their classification and the relevant conformity assessment route that is required. With limited exceptions, all medical devices must be validly marked under the applicable legislation (eg CE marked, UKCA marked or CE UKNI marked, as applicable) before they are placed on the market.
The rules around medical devices in Great Britain largely follow those set out in three EU Directives – Directive 90/385/EEC, Directive 93/42/EEC and Directive 98/79/EC – which are given effect through the UK Medical Devices Regulations 2002 (UK MDR 2002).
Consideration of whether a product qualifies as a medical device begins with the statutory definition. The UK MDR 2002 defines the term "medical device” as it applies in Great Britain as:
"any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, together with any accessories, including the software intended by its manufacturer to be used specifically for diagnosis or therapeutic purposes or both and necessary for its proper application, which
(a) is intended by the manufacturer to be used for human beings for the purpose of
(i) diagnosis, prevention, monitoring, treatment or alleviation of disease,
(ii) diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
(iii) investigation, replacement or modification of the anatomy or of a physiological process, or
(iv) control of conception; and
(b) does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, even if it is assisted in its function by such means, and includes devices intended to administer a medicinal product or which incorporate as an integral part a substance which, if used separately, would be a medicinal product and which is liable to act upon the body with action ancillary to that of the device."
The range of items that could potentially qualify as a medical device is enormous. However, there are two key points to note: the manufacturer's intended purpose and the mode of action of the product.
In determining whether a product is a medical device, the UK's regulator, the Medicines and Healthcare products Regulatory Agency (MHRA) will consider these two factors – which in the case of intended purpose will include the claims about what the product is and what it does – as well as:
Another key definition is that of an "accessory", which is an article which is not itself a medical device but is intended specifically by its manufacturer to be used together with a medical device as intended by its manufacturer. Accessories are also regulated by the UK MDR 2002.
Femtech apps or connected products are software driven. As can be seen from the definition of "medical device" above, standalone software, as well as software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes, are expressly referred to. In other words, software can qualify as a medical device.
The qualification of software as a medical device or accessory can be quite complicated and the MHRA has produced guidance on medical device standalone software, including apps. This provides examples, flowcharts and decision trees (MHRA Standalone Software Guidance), which can help manufacturers assess whether their software or apps are likely to qualify as a medical device or an accessory in Great Britain.
Taking the "control of conception" limb in the definition of medical device as an example, the MHRA's Standalone Software Guidance provide a couple of examples where such software relating to conception may qualify as a medical device. Specifically:
Apps and software that just replace a written diary or log to track or display data related to a woman's menstrual cycle are unlikely to qualify as a medical device. This would, however, require an assessment of how the data is presented and whether that data is analysed to produce new data in a manner that might qualify as a medical device.
Pregnancy test kits will usually qualify as in vitro diagnostic devices (IVDs). In broad terms, IVDs are medical devices that are reagents, reagent products, calibrators, control materials, kits, instruments, apparatus, equipment or systems, whether used alone or in combination that are intended by the manufacturer to be used in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information:
With IVDs, the specimen is not returned to the body.
Breast pumps and feminine hygiene products for the Great Britain market are not generally considered to be medical devices by the MHRA. That said, as noted above, the MHRA will consider a number of factors in deciding the qualification of the product, including the intended purpose and claims made in relation to the product.
A number of changes to the medical device regulatory framework have been introduced following Brexit, but CE marking under the EU medical device legislation will continue to be recognised in Great Britain until 30 June 2023. A new UKCA marking system will operate in parallel on a voluntary basis, which will become mandatory on 1 July 2023. Regardless of whether the device is CE marked or UKCA marked, medical devices (including general medical devices, active implantable medical devices and IVDs) placed on the Great Britain market are required to be registered with the MHRA according to the relevant grace periods for registering. Manufacturers based outside the UK will also need to appoint a UK Responsible Person for products placed on the Great Britain market.
The regulatory framework in Northern Ireland remains aligned with the European Union and the EU Medical Device Regulation (Regulation (EU) 2017/745; EU MDR) has applied in Northern Ireland since May 2021, as transposed in the UK MDR 2002. In the case of IVDs, the EU In Vitro Diagnostic Medical Device Regulation (Regulation 2017/746; EU IVDR) will replace the current rules under Directive 98/79/EC from 26 May 2022.
The definition of "medical device" in the UK MDR 2002 as applicable to Northern Ireland refers to the definition set out in Article 2(1) of the EU MDR. The EU MDR definition of is slightly broader than the definition that applies in Great Britain. For example, the EU MDR definition expressly deems "devices for the control or support of conception" to be medical devices. There are also new classification rules introduced, such as Rule 11 that applies to software. The requirements on manufacturers (as well as importers and distributors) are more onerous under the EU MDR (and IVDR) than the three EU Directives that they replace, so understanding the requirements of the EU MDR and engaging with the requirements early on will assist manufacturers planning to launch in Northern Ireland (or the EU).
The CE marking of medical devices in Northern Ireland remains a requirement, but a medical device can be CE UKNI marked if a UK notified body undertook the conformity assessment of the device. Medical devices also need to be registered with the MHRA, but the grace periods are slightly different than for Great Britain. Great Britain-based manufacturers are required to appoint an EU or Northern Ireland-based Authorised Representative, and most manufacturers based outside the UK will require a UK Responsible Person.
You can assess the likelihood of a product falling with the scope of the EU MDR using our MDR Medical Device Checker tool.
Medical device regulation in the EU has been subject to change with the application of the EU MDR and the EU IVDR on the horizon. However, change may also be coming in the UK. The MHRA has recently published a consultation on the possible future regime for medical devices. It is envisaged in the consultation that the new rules will come into force on 1 July 2023, with appropriate transitional arrangements.
The proposals aim to drive the UK's medical devices sector forward in several significant areas, including creating new access pathways to support innovations and a unique, innovative and ambitious framework for regulating software and medical devices. The consultation sets out proposals being considered for a future UK-wide regime for medical devices which, in Northern Ireland, would run in parallel with any existing or future EU rules in accordance with the Northern Ireland Protocol.
Healthcare is devolved across the four nations that comprise the UK: England, Scotland, Wales and Northern Ireland. For brevity, we will focus on England.
Providing solutions remotely – such as a platform that allows women to consult with healthcare professionals relating to issues like menopause, pregnancy, childbirth or other physiological or mental health issue – can be regulated as healthcare in England requiring registration with the Care Quality Commission (CQC) under the Health and Social Care Act 2008. Specifically, carrying out one or more of the 14 "regulated activities" in England (which are described in the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014) will generally require registration with the CQC.
Digital health solutions can fall within the scope of providing several regulated activities, but the most common are likely to be:
There are some exceptions to these regulated activities but conducting a regulated activity without registration is an offence under the legislation. The CQC's guidance applicable to each regulated activity should be considered carefully to determine whether it is applicable to the services being provided.
Registering as a new provider with the CQC is a lengthy process, which should be planned and prepared for well in advance of submitting the registration application. According to the CQC, the documentation required for the application to register as a new provider can take weeks to prepare, and includes a Disclosure and Barring Service check that must be countersigned by the CQC.
Providers are required to have a registered manager who manages the regulated activity. Organisations are also required to have a nominated individual who acts as the main point of contact with the CQC and must be in a position to supervise the management of the carrying on of the regulated activity. In the case of very small organisations, the registered manager and the nominated individual can be the same person, but the CQC recommends avoiding this where possible.
There are also a number of ongoing obligations that apply to providers and their key personnel. Running any regulated activity will therefore require procedures and policies to be put in place to ensure compliance with the CQC requirements and standards.
The CQC carries out regular inspections of registered service providers, focussing on five questions relating to the service:
Inspection reports and ratings are published on the CQC's website. The CQC has published clarification of its primary care guidance by setting out how it regulates digital healthcare providers in primary care, which provides prompts for these providers to consider.
The regulation of 'femtech' products is a complex area and getting it right is critical. Getting it wrong could mean delays to launch, pulling a product off the market, and possible enforcement action from a regulator.
To discuss your product or any issues raised in this article, please reach out to a member of our Life Sciences & Healthcare team.
by Jo Joyce