New classifications. Stricter indications. Denser data requirements.
The long-standing Medical Device Directive (MDD) has been replaced by the rigorous standards of the Medical Device Regulation (MDR). MDR demands more at every milestone, and those who don’t proactively prepare their data collection for the writing process may be met with serious delays as they are forced to backtrack to fill in the gaps. The most successful medical writers will be those who “know their data” and can confidently lead their MedTech trial from planning to post-market clinical follow-up (PMCF) with one robust data stream.
To avoid delays and accelerate innovations to market, companies must start now by adapting their data procedures and medical writing practices to a new reality. Read our white paper on “the MDR difference” to keep producing precise documentation absent any costly delays.