Medical Device Regulation

Technological and scientific developments lead to changes in healthcare. Software and data are increasingly being used. In addition, more and more devices are connected to each other via the internet and through the use of algorithms, such as machine learning and artificial intelligence, more and more decisions can be made or predicted automatically. These developments have been one of the reasons that the medical device legislation has been updated.

The new Regulation entails a number of major changes for both healthcare institutions and medical device manufacturers. As a healthcare institution, do you know which medical devices you use? Do you know which software products are a medical device under the Regulation? What happens if you add a functionality to purchased medical devices, or if you manufacture an in-house medical device? As a manufacturer, do you know whether your portal, medical software or other software is a medical device? What should you arrange if your digital solution must be CE-marked?

A selection of our services

Gap assessment

For all organizations dealing with medical devices, whether as a manufacturer, distributor or user, it is important to know the status with regard to legislation. What has your organization already arranged well and what could be better? By testing your processes, procedures and products against the legal framework, we can identify which areas still need improvement and how these improvements can be implemented.

Roadmap to compliance

If you develop a medical device, you want to be inhibited as little as possible by compliance issues. With a roadmap to compliance, we can provide an overview of all applicable laws and regulations and provide you with practical action points, so that you can fulfill the requirements as efficiently as possible and can go to the market as quickly as possible.


For implementation, it’s important that your employees understand and accept the processes and implemented measures. Your organization will have to work according to these standards. We can support you in both the preparing and implementation phases. We will only have a facilitating role, without taking over any of your tasks.

Memorandum of applicability

Do you want to know if your solution falls within the scope of the Medical Device Regulation? Or do you want an inventory of the devices that are used within your organization, and to which class they should be assigned? We can support you with writing down the relevant facts and intended purpose of your product and argue whether it could be considered a medical device and, if so, to which class it could be assigned.

Curious about our services within this area? Contact us or download our onepager.

Download Pdf healthcare institutions:

This describes our service for the medical device directive


Download Pdf manufacturers:

Please contact us if you want to have more information.