Today, May 26th, 2021, the new Medical Device Regulation (MDR) will become fully applicable, following the transition period and delay due to COVID-19 pandemic. The EU adopted these new regulations to create a robust, transparent, and sustainable regulatory framework, recognised internationally, that improves clinical safety and creates fair market access for manufacturers and healthcare professionals.
Even though this doesn’t sound like anything a university, research group or even individual researcher should worry about, it will definitely affect all of us working on health innovations.
For instance, if you want to test or do experiments with human subjects, even in your own lab, you will have to comply with certain rules concerning research, medical ethical approval and technical documentation. Another example, the software will be classified as a medical device and will have to comply with more stringent regulations than we knew until now. And last but not least, what if you want to valorize the research results by creating a spin-off or a licensing deal with a company? Well, in that case, the company will have comply and does not want to re-do all the R&D work from the research. So when in the research phase things have been set right, the results are more attractive for commercialization or reaching the market.
It is not desirable nor feasible for the whole UT to adopt the full extent of all the Medical Device Regulations, for example, this would mean very stringent quality management systems that should be used by alle employees, even when they are not connected to health innovation research. That’s why the TechMed Centre set up an MDR task force last year that has been and working on a pragmatic and dedicated approach to supporting the implementation of the new MDR for researchers and support staff working on health technology innovations.
It is important to mention, the primary investigator (PI) will be and stay responsible for health tech research projects. The TechMed MDR task force will provide dedicated support to ensure all projects that will be affected can benefit from and build on this support. This will be done by holding information sessions, providing tools and templates to comply with the MDR in the most unobtrusive way, hold workshops to build knowledge for research groups that want to benefit from the support, and lastly we have a team ready to help with all the questions that might arise during the first period.
MDR information session
First, you can join a digital general information session on Tuesday, June 22nd of 2021 from 16.00-17.00 hours. There, the MDR Taskforce will give a general update, shows the support options and answers the most urgent questions. You are kindly invited to join us, more information and registration.
Workshop series: Accelerating implementation of your health innovation
Dedicated workshops that will build capacity for anyone within the university that is involved in the research & development of health technology. During the workshops, you will learn about regulations, documentation, how to successfully implement your innovation, research on human subjects, research data management and privacy. For more information and registration.
Dedicated support materials
Furthermore, a dedicated MDR quick reference page on either the TechMed Centre intranet or the service portal will be launched after the information session with all the relevant information, easy to use templates, tools and contact information of support specialists. So you have everything you need to get started!
Any urgent questions? Do come to the information session or reach out to our staff.