Plan now for 2016 regulation changes, says Maetrics

Maetrics’ European managing director, Peter Rose, has spoken out that European medical device manufacturers face new regulations in 2016. He outlined the demands and costs of implementation at Medtech Innovation Expo at the Ricoh Arena, last week.

"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," said Rose.

"Manufacturers need to start planning now to be ready to comply by the end of 2016," he warned.

Rose outlined a number of the key areas covered in these new regulations, at the  medical device conference, Med-Tech Innovation Expo. These included:

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," said Rose.

In his opinion 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 imminent. Rose says 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. 

"To successfully implement and comply with the new regulations, it requires an experienced team with global reach to manage time, money and resources. Failure to comply risks notifications, fines, recalls and other sanctions from regulators," he said.