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Medical Device Regulation
Our services for healthcare institutions and medical device manufacturers
On May 25th, the new Medical Device Regulation (hereinafter: “MDR”) has entered into force. The MDR replaces the present Medical Device Directive (hereinafter: “MDD”). As of 26 May 2021 the MDR actually applies, which means that manufacturers of medical devices must comply with the new rules as of this date. In a number of situations, an exception applies to manufacturers of medical devices who already comply with the MDD: in these specific situations, the devices can be used for a longer period of time under the conditions of the MDD. Until 2025, these special transitional provisions apply.
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
Memorandum of applicability
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.
Roadmap to compliance
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.
Gap Assessment
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.
Support
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.
Curious about our services within this area? Contact us or download our onepager.
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