CE Marking Medical Software Class I

medical software class i product example

The CE marking process of medical software class I is well known for being prolonged, cumbersome and very costly. Moreover, many are confused if the software they have is indeed a medical device and needs CE certification.

Are you one of the many? If so, then you need to read this post! Here, you will learn what medical software is, how to CE mark such a product and, most importantly, how to lower your CE marking costs significantly.

So, what is medical software?

Qualifying a software as a medical device is more challenging to be done than you may think.

Usually, any software that is meant for diagnostic or therapeutic purposes, as well as for monitoring of physiological processes, can be defined as a medical device.

However, there are cases when software is stated to be a medical device given the fact that it is an ancestor of another medical device. Moreover, software that drives or influences a medical device is also seen as a medical device of the same class as the medical device it drives or influences.

Probably, you’re already very confused. So, here are some of the most recurring examples of software products mistaken for being medical devices. If your software is one of the following ones, then you most likely don’t need to CE mark it:

  • Software for the administration of patient data
  • Systems for storage of patient data, but without processing it
  • Radiological Information Systems, also known as RIS

But, if you cannot define your software product as any of the listed above types, then it’s better for you to continue reading.

You can also click the button below to run a free test that will verify or deny your software as a medical device.

Which medical software is of a risk class I?

The risk class of medical software determines how complicated and costly is going to be your CE marking process. So, to define the relevant risk class for your medical software, you need to apply the necessary classification rules. These rules are stated in Appendix I of MEDDEV 2.1/6.

Of interest here is medical software class I. Such products have the lowest risk possible and, accordingly, the simplest CE marking process. We’re saying ‘simplest’ in the sense that medical software products of class I don’t need to pass external auditing. The external auditing is only required by law for medical software class II and III.

What is the CE marking procedure for medical software class I?

The CE marking process of medical software class I has several steps, as follows:

  • Verify if the product is a Medical Device.
  • Investigate which class the medical device is.
  • Document Intended Use.
  • Create a product requirements specification.
  • Compile your technical file (Risk analysis, risk classification, Software Development Plan, Software test report etc.)
  • Create product labels and if necessary, warning labels.
  • Create a user manual.
  • Fulfil the Essential Requirements.
  • Prepare CE Declaration of Conformity.
  • Register the Product to your national health care authority.

 

Please note: After you go through the CE marking process and get your medical software CE mark approved, your work is not finished. You need to continue observing its performance and review the experience gained from the post-market surveillance. If you notice any incidents with your product, you need to record and evaluate them.

man thinking about ce marking medical software class i

How much does it usually cost?

Many would describe the CE marking process as very complicated and cumbersome. On top of that, it can also be very costly. The usual price a CE marking consultant will give you is around 40-50,000 euro.

Fortunately for you, there is a cheaper alternative called CE Check. CE Check is a digital self-service provider of CE marking . We can help you reduce the time and cost significantly!

CE Mark Medical Software Class I with the digital CE compliance system of CE Check!

CE Check has developed a unique way for CE marking of medical software. We provide you with templates and then help guide you throughout the entire CE marking process via webinars. All you will need to do is follow our instructions, and your product will be CE marked in no time.