Take note: Medical Device Regulation

19 Feb 2020
Jan Vandecasteele

Dear colleagues,

During the BHPA 2020 symposium we have invited Koen Cobbaert to talk to us about the new upcomming Medical Device Regulation (MDR) and the impact on in-house manufacturing of medical device software. Many of us use in-house developed excel sheets, scripts etc. which can have an impact on medical decisions. Examples can rang from very simple excel sheets to calibrate machines by applying correction factors, scripts to convert count to activity and scripts to calculated target coverage towards more complex things such as tumor segmentation, software for daily QA of ionizing apparatus or independent monitor unit calculation,... 

From 26th of May 2020 all these types of software (also hardware) fall under this new regulation. Please take notice of this if you are affected. BHPA will soon start up a working group how to deal with this and to come up with a Belgian MPE view how we should validate future software into clinical practice.

Please have a look at the presentation attached for more information.

Best regards

Jan

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