CE Marking of Medical Software Class I

CE marking of medical software class i

Say ‘No’ to the expensive and prolonged CE marking process. CE mark your medical software class I with CE Check for only €5,000!

STOP!

Are you sure your software is a medical device? Click the button to find out! It will take only a few minutes.

How can CE Check help you CE mark your medical software class I?

With a number of web seminars, we at CE Check will help guide you through the entire CE marking process, from start to finish. Just follow our structured process. If you have any questions along the way, we will be there to support you.

The first thing you need to do is figure out if you indeed need to CE mark your software (app) or not. Below is a free short questionnaire. Once completed, it will give you an indication of whether you need to CE mark your software or not.

Note: If the final test result is a ‘No’, then continue as you are. But, if the test indicates that you need to CE mark your medical software, then we are here to help you.

Do I need to CE mark my medical software class i

How much do you know about CE marking of medical software?

ce marking medical software class i

Probably not that much, right?

Well, if that’s your case, then continue reading to become familiar with the basics of the CE marking of medical software class I!

Learn what a medical software is, what the CE marking process includes and how much it usually costs to CE mark a medical software class I.

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 with 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 is better for you to continue reading!

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. 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.

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 that can help you reduce the time and cost down to 5,000 Euro! That’s right! For only €5,000 you can have your medical software class I completely CE marked and ready to be placed on the EU Single Market!

Now, you know enough to start CE marking your software!

But before actually doing it, make sure your software needs CE marking.
Click the button, take the FREE test and find in less than 5 min if your software is a medical device.

Our client’s story!

“Before we could take our patient support system to the Swedish and EC markets, we needed to go through a CE-process. After evaluating different approaches, we selected to partner up with CE Check, not only because it was the low-cost alternative, but maybe even more because it helped us build the internal capability to work with the CE frameworks and quality assurance going forward. With the help of CE Check’s digitised platform, we were able to finish the first CE marking process in only a month.”

Andreas Hager
CEO, Upstream Dream

If you still feel a bit confused and don’t know what to do, please contact us.