The regulatory landscape is changing for Medical device innovators and companies with the new European Medical Device Regulation (MDR) EU 2017/745. The MDR provides the regulatory framework for product approval, clinical studies and post-market surveillance, and compared to the Medical Device Directive (MDD), it adds a new level of scrutiny to existing documentation. Companies will also need to generate more in-depth clinical data to prove safety and performance claims, as well as producing the associated clinical study documentation. The regulation also requires the creation of new documents, such as Periodic Safety Update Reports (PSURs) and lay summaries for patients.
It is critical that the information in these documents is presented in a clear and concise manner suited to the level of understanding of the target audience. Ultimately, the success of clinical development, product approval and marketing depends on the readability and reviewer-friendliness of the documentation. In addition, because Medical devices span a spectrum of complexity from plasters to implantable pacemakers, an increasing demand for experienced Medical writers is anticipated.