Navigating CE Marking for Medical Devices: A Cost-Effective Roadmap for Startups

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The path to bringing a medical device to the European Union (EU) market is paved with challenges, chief among them being successfully acquiring a CE mark. The CE mark certification is a passport for your medical device, allowing it to be sold across all EU countries. The CE mark for a medical device carries with it many more requirements than other CE marked products. But what does it take to achieve this crucial mark, and at what cost?

Understanding CE Marking for Medical Devices

CE marking is more than a formality; it's a declaration that your product meets EU standards for health, safety, and environmental protection. For medical devices, this involves a rigorous process ensuring the product is safe and effective for its intended use. This process can drag on for months and often years if not managed effectively, which makes it a high priority for startups who need a fast path to revenue and avoid expensive delays.

Your guide for CE marking will be the EU Medical Device Regulations (MDR)2017/745, which came into effect in May 2021. These regulations define what is required to bring your medical device to market in the European Union. In addition to MDR, you will likely find yourself reading through international standards created to help manufacturers create medical devices of sufficient quality, safety, and performance to make it onto the market. This will likely include ISO 13485:2016 for your quality management system, IEC 62366:2015 for usability, ISO 14971:2019 for risk management, and IEC 62304:2006 for software lifecycle development, to only name a few. The MDR and international standards are not known for being easy to read or provide practical approaches for how they should be met.

It sounds complicated already, doesn't it? Well, there are some groups like the Medical Device Coordination Group (MDCG) and the International Medical Device Regulators Forum (IMDRF) that have made an attempt at providing some guidance around how to meet the regulations and international standards. However, for those that are not familiar with medical device regulations, these often sound just as confusing as the MDR and international standards themselves.

A good starting place would be to make sure your product is a medical device in the first place. The definition for a medical device according to MDR is below:

'medical device' means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes:
— diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease,
— diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability,
— investigation, replacement or modification of the anatomy or of a physiological or pathological process or state,
— providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations,
and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means.

If your product is a software device, check out this handy guidance from the MDCG that describes how software is qualified as a medical device or read our blog post about it. The EU MDR includes software as a medical device more often than not and it should be considered independently of the above definition.

If think your product may fit the definition of a medical device, read on as we break down the certification steps.

The Road to Certification: What’s Required?

The journey to CE marking involves several key steps:

  1. Develop a Quality Management System (QMS): This system ensures consistent product quality and compliance with EU regulations. Essentially a QMS is a set of company procedures to ensure medical device quality.
  2. Creating Technical Documentation: Your device must be thoroughly documented, proving that it meets all necessary regulations. This is called your technical documentation.
  3. Creating a Technical File: This comprehensive file includes all the details about your device, from design to manufacturing.
  4. Undergoing an Audit: An essential step for most medical devices where your product and processes are evaluated for compliance.

The key to demonstrating your product is compliant with regulations and ready for a CE mark is: Documentation, documentation, and more documentation.

What needs to be documented? In short, important aspects of your medical device creation, testing, market entry, and market experience should all be documented. Additionally, your company should be able to demonstrate they have the necessary resources and personnel to create and maintain a medical device that meets regulations for performance and safety. It sounds like a lot and it is a lot, but it can be managed in a non-burdensome way if the right approach is taken.

How Startups Can Tackle CE Marking

For startups, the path to CE marking sounds daunting. Let’s face it, most startups don’t have a regulatory or legal specialist in their founding team and regulations can be extremely confusing or feel impossible to understand. Creating all of the required documentation can seem an insurmountable task given how thinly stretched co-founders tend to be.

When tackling CE marking in general, an important first step would be to establish your quality management system according to ISO 13485 standard. This is a basic requirement for all medical device companies and will be necessary for you to to achieve the CE mark. Once you have set up your QMS, you can proceed with generating the technical documentation required to demonstrate your particular medical device is ready for its CE mark. The requirements for your technical documentation will be product specific and will differ if your product contains software, electrical components, sterilized components, or emits radiation.

The most common approach for startups without dedicated regulatory consultants on staff is to outsource one or all parts of the QMS and technical documentation. As you can imagine, outsourcing to expert consultants will be the safest option but it carries a hefty price tag and can take some time. The consultants work with the startup to create their quality management system and the technical documentation for their medical device. This takes place over many meetings and countless emails. Not every startup has the resources to outsource everything to high price consultants.

For that reason, some startups try to create their regulatory documentation in house themselves. You can buy templates online, read blogs, buy the standards, and try to build everything yourself. While this option is definitely cheaper, it is extremely time intensive and provides no guarantee of successful CE marking. You are essentially learning complex regulatory requirements from scratch for which the possibility of making a critical mistake is very high.

This leaves most startups doing a combination of both outsourcing and work themselves to try and meet product release deadlines and stay within budget. This a la carte approach can be tricky and may lead to more inconsistencies than trying to tackle the CE marking journey using one approach alone. The startups we have spoken to would prefer to manage everything in house but, without a solid understanding of where to start in the regulations, they end up outsourcing.

The Costs of CE Marking: Balancing Risk and Investment

The financial aspect of obtaining CE marking can't be overlooked. As mentioned, hiring regulatory consultants is expensive and can easily exceed $50,000, a significant cost for any startup. While regulatory consultants will cover all aspects of CE marking requirements, the work can be time consuming with project deadlines reliant on both parties communicating frequently and staying on task. Pricing often lacks transparency which may lead to insurmountable costs and confusion about whether you can meet your CE marking timeline in time and under budget.

Opting to manage the process internally is less costly (under $50,000) but carries its own risks. For starters, if you have no dedicated regulatory specialist on staff, you will need to learn the regulations in some part yourself (get ready to burn the midnight oil!). This means that you may not know for certain if the documentation you created will pass the bar for EU CE marking compliance, a risk many are not willing to take.  

So which route is best for success? It depends on your particular startup's runway, resources and expertise.

A New Solution: Fast, Cost-Effective CE Marking with Formly

Here is where Formly changes the game for medical device startups.

At FormlyAI, we understand the complexities of MDR medical device certification. Our service provides a streamlined, efficient path to CE marking and all the tools to ensure your medical device adheres to all necessary EU regulations. All for a fraction of the cost of using traditional consultants. This way you can build your compliance documentation and apply for CE marking in a matter of weeks, not years.  

Learn more about our software and accelerate your path to CE marking with Formly.

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