Medical and Regulatory Affairs

Experts to Discuss EU Regulations at OCT Medical Devices Europe

DURHAM, N.C., February 6, 2018 — Two Premier Research medical device experts will examine the impact of upcoming changes to European medical device regulations at Outsourcing in Clinical Trials Medical Devices Europe 2018. Joanne Emmett, Vice President for Medical Device and Diagnostics, and Janet Kube, Director, Project Management, will discuss the new EU Medical Device Regulation on February 7 at the conference in Munich.

Topics will include:

  • How the transition to the new medical device and in vitro device regulations will require that all products with CE mark certification be recertified over a period of four to six years.
  • A provision that allows authorities to take a second look at technical documentation prior to CE approval of high-risk devices and requires Notified Bodies to submit new technical review reports, potentially delaying submissions.
  • Stricter comparative evaluation rules that will make it much harder to demonstrate product safety and performance using equivalence data. The new rules require more data, and it will be more rigorously interpreted.

About Premier Research
Premier Research is a leading clinical development service provider that helps highly innovative biotech, specialty pharma, and medical device companies transform breakthrough ideas into reality. The company has a wealth of experience in the execution of global, regional and local clinical development programs with a special focus on addressing unmet needs in areas such as analgesia, dermatology, medical device, neuroscience, oncology, pediatrics, and rare disease. Premier Research operates in 84 countries and employs 1,100 professionals, including a strong international network of clinical monitors and project managers, regulatory, data management, statistical, scientific, and medical experts. They are focused on smart study design for advanced medicines that allow life-changing treatments.