Abstract The 2010-2011 Poly Implant Prothèse scandal triggered a review of the Medical Device Directive. This resulted in a new Medical Device Regulation that was approved this year. It contains many changes, and many questions will arise when medical device companies start certifying their medical devices per the new regulation. The solution to many unclear cases will depend on how the new regulation is interpreted. Medical writers can play a key role by creating precedents that are coherent, well documented, and useful for all stakeholders