The Best Laid Plans...
How often do we see grand developments, in healthcare and other spheres, disrupted by problems affecting major IT projects that are essential to the plans? UK healthcare professionals won’t need to be reminded of the failure to achieve a single electronic system of patient records for the whole of the National Health Service, for example.
Currently, two sweeping changes to the regulation of medicinal products and medical devices in Europe are stalled, in large part by IT problems. To be fair, reasons for the postponement of the implementation of the EU Medical Device Regulation (MDR) until May 2021 include the Covid-19 pandemic as well as delays to the EUDAMED database. The postponement has brought relief to many medical device companies who were fearful that inadequate access to notified bodies designated in compliance with the MDR would cause crippling delays to the certification of their products.
It is no surprise, however, that the long delay to the implementation of the EU Clinical Trial Regulation, enacted in 2014, can be blamed squarely on the development of the portal, now known as the Clinical Trials Information System, that is essential to the regulation. Implementation is now expected sometime in 2021, but we’ve had great expectations before ….
We will of course keep our clinical trials and medical device modules up to date with developments.
Watch this space!