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Downloads

A lot of information is available about regulatory-related topics pertaining medical devices. On this page you can find downloads which are made available by Unitron Regulatory. If you have any questions about a certain document or disclosed information please contact us.

MDR readable edition

The MDR was postponed and came into force on 26th May 2021. As a gesture to the medical device industry we would like to provide our own ‘readable’ version of the updated MDR. We offer this download for free and will not collect any personal data. We only ask you to answer 1 multiple choice question which you will see when you hit the “download MDR readable edition” button.

So, are you confused about sections, subsections, articles, chapters, parts and points of the MDR? Tired of getting out your reading glasses or zooming in on an all too small screen in order to read the MDR’s small text? Download our easily readable, indexed, interlinked and booklet-printable version of the MDR text for free!

Electronic Instructions for Use

In the first week of 2022 a new regulation came into force, EU 2021/2226! This Regulation on electronic instructions for use (eIFU) of medical devices can be downloaded below. Unitron Regulatory included a qualification flowchart to help determining if an eIFU can be provided instead of a paper IFU.

Below a list with all documents made available by Unitron Regulatory: