To help researchers deal with the new medical device regulations, the Faculty of Science at the VU has started a MDR research support group for all researchers conducting, or intending to conduct clinical research with medical devices.
On May 26th 2021, unbeknownst to many, new Medical Device Regulations (MDR) came into force issued by the European Union. Where previous regulations merely regarded software embedded in medical hardware devices, or driving external medical devices, the new MDR now introduces an extension of the definition of software as a medical device. Software, defined as a set of instructions that processes input data and creates output data, is now also considered a medical device if the software serves a medical purpose on its own. Whether software serves a medical purpose is directed by the intended use of the software.
Consider e.g. a machine learning recommender system providing the user with healthy food suggestions. Merely offering a suggestion would not classify this recommender as a medical device. However, if the intended use of the recommender system is to suggest certain types of food to prevent obesity or diabetes the intended use is now medical: to prevent a disease.
Broadening the scope of software as a medical device means that in an era where AI solutions in health are becoming more ubiquitous, AI researchers and developers in and for healthcare (or software researchers and developers in general) could be subject to the new regulations. The new regulations will apply if they either want to launch their product (i.e. their software medical device) to the market or do clinical research on human subjects.
For clinical research with (software) medical devices, several terms and conditions are stated in the MDR under which this research is to be performed They are defined however loosely enough to warrant difficulty in the implementation of these rules. To help researchers deal with the new medical device regulations, the Faculty of Science at the VU has started a MDR research support group for all researchers conducting, or intending to conduct clinical research with medical devices.
The goal of our group is to assist researchers with the implementation of regulatory issues and to firmly ensure that free and innovative work will continue to thrive.
Please contact Dr. rer. nat. Patrick González, Medical Device Development Expert, at p.j.gonzalez@vu.nl for any questions pertaining to software medical device research.