On May 26, 2017, the European Regulations on Medical Devices (MDR) and In Vitro Diagnostic Devices (IVDR) entered into force. The MDR will apply on May 26, 2021 and the IVDR on May 26, 2022. These regulations extend the current legislation and regulations with the aim of further protection of the European citizen. One of these extensions concerns the qualification of medical devices. For example, under the MDR, software will sooner be classified as a medical device than is currently the case.
If you are a manufacturer or importer of medical devices, or if you are otherwise dealing with them, it is advisable to obtain information in advance and make the necessary preparations for the MDR.
First Lawyersorganizes a master class in which the most important aspects, rights and obligations, and consequences for your business operations are discussed. In doing so, we pay attention to, among other things, the parties that are addressed by the regulations, the requirements set by the regulations and we specifically address the question in which cases software should be regarded as a medical device.
After the masterclass, you will know what the consequences of the MDR are for daily practice and what preparations are required to comply with the MDR on 26 May 2021. During the meeting and after the conclusion, there is of course the opportunity to ask questions.
First Lawyers attorneys can provide legal support in preparing to be demonstrably compliant and accountable, click here for more information.