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Overview on the regulatory path for software medical devices

You might have heard several times that the key to success is not the idea but the path you follow to make it attractive to the customers, and it is indeed that. In the healthcare industry, if you are developing products to make the diagnosis more accurate, make the doctor’s life easier or make the diagnosis faster you shall not only think about how good your idea is, or if your customer are willing to use it, you shall think how to get it into market, and this forces you to think about certifying your product.

In Europe exists the CE mark, a mandatory conformity regulated by the European Union that assures that a product meets all the requirements of the relevant recognized European harmonized performance and safety standards, and therefore, can be sold within the EU, [1].

Figure 1: Types of CE classes [7].

Once it is clear the norm that a product shall fulfill, there are several classes within the CE Mark regulation and, depending on which class your product lands in, the requirements to obtain the CE Mark change.

In Figure 1 it is shown the different classes that exist. The higher the risk is for a patient, the bigger the class will be.

Here the description with some examples about all the available classes, [3]:

Class III: all medical devices that have the highest risk possible, and permanent monitoring is required during their lifetime. Ex: cardiovascular catheters, aneurysm clips, hip-joint implants, prosthetic heart valves, and others

Class IIb: They are medium to high-risk devices, and patients may use them for a period longer than 30 days. Ex: long-term corrective contact lenses, surgical lasers, defibrillators, and others

Class IIa: Software intended to provide information which is used to take decisions with diagnosis or therapeutic purposes that will not cause serious deterioration of a person’s state of health or a surgical intervention; Ex: surgical gloves, hearing aids, diagnostic ultrasound machines, etc.

Class I: All other medical device software

Not a medical device: software for general purposes, even when used in a healthcare setting, or software intended for life-style and well-being.

It is important to note that in class I or, no clinical trial with real patients is needed. It is also called self-declaration or self-certification. It is the fastest way to entry the market. It usually takes around 3 months to get the Class I CE Mark and only some technical documents about your product and its quality shall be drafted.

Although this seems a good way to go, Class I products usually do not provide a big value proposition to the end-user and are therefore hard to sell. One example would be a software the highlights areas in a CT scan with abnormalities, without classifying it or making a preliminary diagnose. This software would help the radiologist in this case but is not suggesting any treatment, so in the end, the product might end up increasing the workload of the radiologists, what makes it less attractive.

From Class IIa onwards, clinical trials with real patients are required and the higher the class is, the bigger the trial shall be, with more patients, involving several centers, etc... This is very costly and time consuming. Together with that, all classes but class I require the external assessment from a notified body, which is an organization that assesses the conformity of certain products before being placed on the EU market, [4]. These notified bodies are limited and have a long waiting list, what slows down even more the certification of your product.

An important final remark regarding European regulation is the difference between medical devices and IVD (in vitro diagnostics).

IVD fulfill their role based on information that they provide and not on their direct action on the patient, [5]. These products usually extract biomarkers from blood samples, or analyze DNA sequences, etc…

IVD have a different regulatory path than MD (medical devices). In the following image it is shown the relation between both and some typical examples.

Figure 2: IVD vs MD regulation, [6].

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