Medical Device Regulation

Do you want to know whether your solution falls within the scope of the MDR? 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.

Within your organization, you want to be inhibited as little as possible by issues related to compliance, both during the development of in-house manufactured devices and regarding the rest of your services.

By means of a roadmap to compliance, we can provide you with an overview of all the requirements that follow the MDR and other relevant applicable standards. We can carry out a practical translation in order for you to comply with all applicable rules in the simplest and most efficient way possible. You can continue to use this dynamic document to remain compliant.

We can support you by mapping out which medical devices you use in-house, what your processes and procedures currently look like and to what extent this meets the requirements set by (among other things) the MDR.

After completing the assessment, you can get started with the documents supplied by us: an assessment framework to complement yourself, a report of the assessment carried out and a practical guidance.

The MDR calls for renewed processes and awareness. For example, under the MDR, healthcare providers are obliged to make the implant information and the implant card available to patients who have received an implant. Healthcare professionals also have obligations with regard to the Unique Device Identification System (“UDI”). They must store and keep the UDI of the class III implantable devices they have supplied.

We can support you during the preparation, implementation and execution of these rules and procedures. We can facilitate you throughout the entire compliance transition on ad hoc basis.