European Union Changes in Medical Device Regulations, Miami, USA
26-27 April 2018
The Society of Clinical Research Associates (SOCRA) is a non-profit, charitable and educational membership organization committed to providing education, certification, and networking opportunities to all persons involved in clinical research activities. The SOCRA 12th Annual Device Research & Regulatory Conference was held at the Miami Beach Resort on 26-27 April 2018, during which was discussed current issues relating to compliance, development, and medical device clinical research. A half-day optional Device Basics workshop preceded the main conference.
The second day of the conference included a presentation from DLC's President, Maria E. Donawa, M.D. on the subject of 'European Union Changes in Medical Device Regulations'. The EU has introduced sweeping new regulations for medical devices, including in vitro diagnostic devices, which will become mandatory in 2020 and 2022, respectively. Given the extent of the changes, this is not a great deal of time for all involved parties to be ready for compliance. This session provided an overview of these regulations and highlighted the new requirements that will represent the most significant challenges for compliance.