Introduction to regulatory law for women’s health companies with Dr Amy Russell

Bridie Houlihan

Bridie Houlihan | Founder & CEO of Female Health Founders


In conversation with Dr Amy Russell managing director and founder of Russell Regulatory Consultants. They discuss all things regulatory law for women’s health and Femtech based businesses in the UK & EU.


Hello Amy, thank you for joining me today. Could you start by giving our Female Health Founders readers a brief introduction to your background as a medical devices regulatory consultant?

Hello there, my name is Dr Amy Russell and I am the managing director and founder of Russell Regulatory Consultants. I have a PhD in vascular physiology, specialising in diabetes mellitus. I began my career in the medical devices industry while working for a notified body and then went on to work for two global medical device manufacturers before starting Russell Regulatory Consultants. I have gained valuable experience in all aspects of regulatory affairs, including developing and implementing the initial regulatory strategy for a device, creating, and maintaining technical files and managing and addressing any non-conformities following audit. All the while, maintaining a sound knowledge of up-to-date regulatory standards and applying any changes where necessary. I set up my own consultancy in 2018 with the aim of bringing a more modern approach to the ever-evolving medical device industry. Over 5 years on, I now have a team of specialists, we work with medical device companies from all over the world, helping them to navigate their way through the regulatory landscape and ultimately get their product to market or keep it there.

For a female founder who is new to the world of regulatory law, can you break down what ‘regulations’ really mean when it comes to women’s health products in the UK and EU?

In a nutshell, regulations are the rules you must follow to get your device onto the market. At one time, ‘Directives’ and ‘guidance’ were the buzzwords but now, with the introduction of the EU Medical Device Regulation 2017/745, it is no longer guidance or advice on how to do things but a more stringent set of parameters to follow. This can be a ‘double-edged sword’ depending on how you perceive it – it can be a positive as it leads to improved outcomes in terms of patient safety and device efficacy. However,

for some, increased legislation translates as stifling innovation and creativity. To medical device start-ups, it may seem like another huge headache, but getting this right means being able to sell your device on a large scale.

-Dr Amy Russell

The new EU MDR specifies a longer list of ‘General Safety and Performance Requirements’ vs the previous Medical Device Directives ‘Essential Requirements’ so this list is a good place to start to investigate how to design a product for the EU market if you are a medical device manufacturer. 

As FemTech encompasses ‘traditional’ medical devices and in vitro diagnostics (IVDs), apps, wearables, software as a medical device (SaMD) as well as wellness products, a much broader knowledge of standards and regulations are required to best serve this area. 

So, in the EU the regulations are set by the European Commission and you are given certification to sell your device by a Notified Body who will audit your systems and technical information on the device.

The first thing you must establish is whether or not your product is in fact a medical device and if so, what regulation it falls under.

-Dr Amy Russell

It may be within the scope of the MDR, or the IVDR, which refers to in vitro diagnostic devices. This is vital as getting this wrong can mean heading off down the wrong track. Clear intended use and indications for use statements are imperative at this stage to determine how your product should be regulated and then what requirements apply. It’s not always straight-forward either.

For example, something as simple and well established as a tampon may be presumed to be under the MDR or the cosmetic products regulation, when in fact it falls under the General Product Safety Regulations 2005.

-Dr Amy Russell

Once you have determined that, it’s about discussing the risk of your device and assigning a ‘class’ to it based on that. Companies often really struggle with this but again it’s fundamental as it affects the regulatory process following that. It’s then about selecting a path to market, building systems and maintaining them so you have in essence, a ‘plan’ on how to get your device onto the market. General safety and performance requirements, set out by the regulation must be followed strictly and how your device conforms to these must be demonstrated. This must all be documented and recorded in your technical documentation, which will be made readily available to your notified body and kept continually up to date. It must be kept in mind that a technical document is never truly ‘finished’, under MDR your technical document plus the input documents that feed into it such as risk management, post market surveillance etc are considered live documents so under constant evolution for the lifetime of the device. Following this will be assigning unique ID numbers to the device, declaring officially that the device conforms to all regulations and then affixing the appropriate mark, ready to be sold on the market. The work continues thereafter as post market surveillance and response to any required updates is undertaken.

The quality management system of your company must be audited regularly, as well as the technical documents themselves and these audits come at a cost so also worthwhile for manufacturers to bear this in mind. Notified bodies are particularly overwhelmed at the moment so if you are applying for certification for a new device, be prepared to wait not only months but years in some cases.

The MHRA sets the regulations for the UK. The regulatory landscape in particularly the UK is an interesting one at the moment.  In terms of FemTech, the UK comes second only to the US with the largest number of startups promoting a device relating to women’s health.  It is estimated that the UK FemTech industry will be worth almost £61 billion by 2025 (Femtech: five UK startups and scaleups to watch – UKTN | UK tech news). Following Brexit, the UK stopped following the EU MDR, instead opting for UK MDR 2002, which is based upon the previous Medical Device Directive. However, the UK government has repeatedly extended the period by which CE marked devices will be accepted in the UK. They have also created pilots such as the Innovative Devices Access Pathway (IDAP) which allowed developers to enter their innovative device into a scheme which would provide regulatory support and guidance. They have since updated, in early January, with a Roadmap for the Implementation of the Future Regulatory Framework for Medical Devices (Implementation of medical devices future regime – GOV.UK (www.gov.uk).

Dr Amy Russell, Regulatory Law,

How do these regulations affect the everyday consumer, especially women using health products?

This is a rich area for discussion. Tightening the regulations could be seen in some senses as a solely positive thing for consumers. Surely, it leads to safer and more reliable products. Some may say it also leads to more a more informed industry which inevitably plants the seeds of innovation of new products. However, there is a school of thought that more stringent legislation actually blocks innovation. It’s encouraging to see early signs that the UK government hope that isn’t the case with fresh discussions and plans, the Women’s Health Plan in Scotland (Women’s health plan – gov.scot (www.gov.scot)) and the Women’s Health Strategy for England (Women’s Health Strategy for England – GOV.UK (www.gov.uk)) attributing to this. FemTech is fast becoming an ever-popular area of discussion, which is of course fantastic. A medical device industry, abundant in cutting edge technology, expertise and healthy debate can only be a good thing for FemTech and in fact health outcomes across the board. 

Absolutely – I touched on this a little in an earlier question. This is basically a system by which to give your device a class rating in terms of the risk it poses. So, for example, a disposable face mask is a class I device, as it poses relatively little risk to the user or anyone else. Whereas an Intrauterine Device (IUD), such as a contraceptive coil, is a class III device as it is implanted and if anything was to go wrong, it would pose a much greater risk. This means the IUD will be subject to more rigorous regulations in order for it to reach market and remain there. Getting classification right is critical as the paths you will follow will change depending on the class of your device, including how in depth your documentation is required to be. It is important to note that with such a lot of innovation in FemTech, classification can be tricky. An example of this is explored in my answer to the next question.

Women’s health products often have unique considerations. What are some specific challenges or nuances that businesses should be aware of when navigating regulations for women’s health devices?

I think a good example of this could be ‘digital contraceptives’. These are apps that help users track their monthly menstrual cycle in order to prevent unwanted pregnancy. Some people favour them over hormonal or more conventional forms of contraception such as medication or implants. However, there are figures to suggest that the incidence of unwanted pregnancy is higher in the groups using the digital methods. There is also suggestion that the classification of the digital contraception apps is unduly low and they should be reclassified to accurately reflect the true risk (Rethinking the regulation of digital contraception under the medical devices regime (sagepub.com)).

Another prevalent consideration is that of Data Privacy in terms of FemTech apps. Many women in the US have deleted their FemTech apps which collect data about their health due to fears of this information being used against them. This is following the widely publicised overturning of the Roe vs Wade case, which has not only led to increased regulation on abortion in some parts of the US but has also cast doubt on how private our collected personal information really is (Why US women are deleting their period tracking apps | Privacy | The Guardian). The point is, there are indeed some unique challenges facing businesses in this area of industry. Mix that with the fast moving regulatory landscape and it becomes quite the task. Surrounding yourself with the right team is key.

Given changes, especially post-Brexit, how have regulations for women’s health products evolved in the UK, and what implications might this have for businesses operating in this space?

The UK is now made up of two jurisdictions – Great Britain (Scotland, England and Wales) which following Brexit, now follows the UK MDR 2002, and Northern Ireland, which continues to follow the EU MDR. With regulation as it stands currently, every product must have either a CE mark, UKCA mark or CE UKNI mark. It is crucial that businesses adhere to the applicable regulations and their device bears the correct symbol or they risk the regulatory body revoking their licence to sell their device. In particular, given that women’s health products tend to be innovative, businesses should accept that the MHRA, when discussing classification of a device, will take each device on a case by case basis as a lot of the technology involved has not been seen before or not used in a particular way.

With innovation being a driving force in women’s health, how do emerging technologies and innovations in women’s health impact regulatory compliance, and how can female founders stay ahead of these changes?

There could be an immense impact on regulatory compliance as new technologies and designs are unlikely to be regulated at all or fully so this will mean regulatory bodies creating new regulation to cover these new technologies to ensure safety and efficacy of devices for patients and consumers. Female founders can stay ahead of these changes by staying up to date with the latest news from their regulatory bodies and the health tech industry generally.

It is also useful to network within the industry; not only with other founders but reaching out to a regulatory consultancy and having an informal chat about what they can bring to your business.

-Dr Amy Russell

Their sole focus is keeping up with all the developments in the industry and using that knowledge, help you navigate the regulatory landscape. Drafting in this extra help can really ease a lot of the burden. (FemTech | McKinsey)

For our readers who are entrepreneurs in the women’s health sector, what advice would you offer to proactively address regulatory considerations, especially from the early stages of product development?

Never become complacent in terms of your documentation or deadlines for submissions. There have been multiple extensions granted on the MDR and many companies have fallen into the trap of thinking they have plenty of time and putting their regulatory documents on the back burner. Submissions often need changed or reapproved so giving yourself plenty of time will avoid stress. Work with a consultancy or regulatory team that you can freely communicate with. Document housekeeping is also a good tip. Being able to find that document you need to refer to in a moment of crisis is a must.

FemTech is a newer market, many of the companies bringing products to market are start-ups with limited funding, meaning that there is risk of regulatory oversight and the issues that come with ‘too little, too late’.

-Dr Amy Russell

It is therefore fundamental that FemTech companies have accessible resources to ensure that regulatory landscapes are understood in terms of requirements, timelines and budgets. Having clear oversight on this can also help with investor confidence.


3 take-away actions for female health founders

  1.  Stop doing this: Being complacent with regulatory
  2. Start doing this: Investing in regulatory early on to gain competitive advantage
  3. Visit russellregulatoryconsultants.com

References