When Innovation Outpaces Regulation: 7 Steps to Becoming CE-marked Here's what it was like working to create a new regulatory category.
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It's not easy being the first.
As any founder will know, building a business is very challenging. The pressure to deliver the best product and service to customers, hiring the best people who share your vision, ensuring everyone performs at their best, and working toward profitability and fundraising–it's a lot of pressure. In addition to all of this, carving your way through an unknown regulatory jungle certainly adds to the challenge.
When your idea carves out an entirely new market, it's going to be exposed to extreme scrutiny, which for any entrepreneur can be daunting. The Natural Cycles concept emerged as many do, from a personal need and identifying a void in the marketplace.
As the world's first and only digital contraception, there was no existing regulatory category that suited our product offering, so we had to work with the regulators to create our own. Here, I'll take you through why being CE-marked matters, the journey we went through, and where to start if you find yourself in a similar situation.
Why does being CE-marked matter for a healthtech startup?
Any app that monitors a physiological process, like the menstrual cycle, is a medical device by definition and must comply with medical device regulations–and any such device in Europe must be CE-marked. If you haven't heard of this before, it's a certification that your product conforms with health, safety, and environmental protection standards for products sold within the European Economic Area. The more the device impacts the human body, the stricter the regulations, the higher the scrutiny on the clinical evidence, the product and the company's processes.
Both the product and the company's way of working have to be designed in a way to ensure that the user's safety is at the centre of every decision–regulations lean on international standards, such as ISO 13485, 62304,14791 to name a few. The goal for a healthtech startup is basically to move as fast as you can within this regulated environment designed to protect the users.
There were, and still are, many challenges in establishing a new regulatory market category and becoming CE-marked.
First, existing regulations couldn't keep up with our pace of development. Our product didn't fit into the existing regulatory mould that was updated once every two years–the app code we use changes almost every day.
In addition, as an app manufacturer, there are things that are impossible to comply with because of how apps are distributed. For example, for certain medical devices, you need to provide the user with a paper manual. It's fine if you buy a product in the pharmacy, but impossible to comply with if someone downloads the app but leaves no information about where to ship the manual to.
In Europe, market regulations are strictly moderated, and in recent years many regulators have decided to close down notified bodies. For us, this meant coming up against another bottleneck, with less notified bodies out there to grant market access. As a result, notified bodies try to reduce the classification of devices that doesn't require approval from their side, but from the regulators directly.
Regulators, however, are held responsible if people get hurt and they don't have the resources to oversee all these class I products. So, they push products into a higher risk category (and back into the hands of notified bodies)–and the rigmarole continues.
Where do you start?
For those founders exploring a new niche, it's worth remembering that although it's challenging being the first, it's all for the benefit of your customer. Wholeheartedly backing and believing in what you've created will drive you through the compliance maze.
Here's where to begin:
1. Begin by reading the law.
It's actually not that complicated. You'll get very far on your own, but do bring in advisors or consultants relatively early to avoid reinventing the wheel. Still, to have good conversations with the experts, it's good if you brush up your knowledge first.
2. Describe your product accurately.
Ultimately, advertising will have to be tied back to clinical evidence. Depending on how you advertise your product and how you intend it to be used, it will be considered high, medium, low, or no risk to your users. This is a highly strategic point early in your development. Make some tests on what's most important to the user about your product and advertising.
3. Figure out what risk category you are.
Once you know your intended use, go through the free medical device classification framework and figure out whether your product is a medical device and, if so, what risk category it is. For context, Natural Cycles is class IIb product if it's intended to be used for birth control; class I product if intended to plan pregnancy.
4. Select your notified body.
If you are riskier than a class I product, then you'll need to find a notified body that will certify both your product and company; we used Tüv Süd. Authorities, even if they can't openly admit it, respect and trust some notified bodies more than others. Picking the right partner means you'll be less likely to be investigated and your notified body will be more likely to defend you in an investigation.
5. Back up your claims with clinical studies and data.
Original, real life data is preferable here. We take what we do very seriously and there's no such thing as too much research or documentation on your product's performance and safety.
6. Be persistent.
As an entrepreneur pushing for regulatory approval, you must be proactive and persistent in getting your approvals over the line. Startups carving out a new regulatory approval category have a responsibility to navigate the slow and winding road to delivery, no matter what hurdles arise.
7. Share your experience.
You're not alone on this journey. Navigating regulatory affairs would be far easier and more efficient if entrepreneurs shared information about the process with one another. It's a world cloaked in secrecy and complexity, but it doesn't always need to be.
It took us nearly two years of working with regulators, annual two-day audits, surprise visits, weeks of preparation for these audits, and years of research to show regulators the evidence trail to achieve CE-marked status. Although the process was daunting, it helped our company to mature much faster and has been crucial in helping us land partnerships with major organisations and investors. We were also able to leverage what we learned from the CE mark process to become the first and only FDA cleared birth control app in the U.S. in 2018.
It's unlikely that you will be able to build a large business in health without having to deal with regulations, so it's better to get that early into your company culture and figure out how to move fast without breaking things.