Plan now to comply by 2016

European medical device manufacturers face new regulations starting In 2016.

April 10, 2014
Manufacturing Group
Industry/Regulations Contract Manufacturing Design/Engineering Devices/Implants/Equipment People/Facilities

Indianapolis, Indiana - "Although there is a great deal of debate still occurring throughout Europe's political and medical device communities, it is virtually certain that comprehensive new medical device regulations will soon be adopted for implementation in 2016," according to Peter Rose, managing director of Maetrics Ltd., the European operations of global life sciences consulting firm, Maetrics. "Manufacturers need to start planning now to be ready to comply by the end of 2016."

Rose outlines a number of the key areas covered in these new regulations:

  • Reclassification of certain devices
  • Single use devices and reprocessing
  • Invasive/implantable devices without a medical purpose
  • Qualified person
  • Unique device identifier (UDI) and traceability
  • Vigilance system

"A common thread will be the standardization of regulations and the centralization of information through the EUDAMED database, even though many of those details are still being finalized," Rose says.

He feels that it has always been a goal of the European Union to update the Directives to take into account new technology (nanotechnology, IVD tests) and streamline the "messy" patchwork of regulations. However, now that these changes are at hand, many European medical device manufacturers have underestimated the planning and expertise needed to modify policies and procedures. Complying with the new regulations will involve cross-department and multi-function planning, including collaborating with suppliers and distributors.

Source: Maetrics