Cere­nion C‑Trend® Soft­ware Library receives MDR Cer­tifi­cate

Cere­nion C‑Trend® Soft­ware Library is now cer­ti­fied as a CE-marked Class IIb med­ical device under the EU reg­u­la­tion on med­ical devices.

What is Cere­nion C‑Trend® Soft­ware Library

The Cere­nion C‑Trend® Soft­ware Library trans­forms the com­plex raw EEG sig­nal into a set of sim­ple para­me­ters that acute health­care clin­i­cians can read and act upon. It is cur­rent­ly avail­able on Bittium’s Brain­Sta­tus EEG mon­i­tor in the EU under MDD since the year 2021. C‑Trend® soft­ware com­bines Cerenion’s inno­va­tion, the C‑Trend® Index, with oth­er quan­ti­ta­tive EEG-derived para­me­ters that yield infor­ma­tion on an acute­ly ill patient’s brain func­tion. Using the C‑Trend® soft­ware, it is pos­si­ble to mon­i­tor EEG slow wave activ­i­ty, burst sup­pres­sion ratio (BSR), aEEG, and Alpha-Delta Ratio (ADR). These para­me­ters may be used to detect brain ischemia and mor­pholo­gies that are typ­i­cal in epilep­tic seizures, as well as adjust the depth of seda­tion and eval­u­ate the recov­ery after car­diac arrest. In addi­tion to bed­side view, the results of C‑Trend® analy­sis can be viewed remote­ly by a con­sult­ing neu­rol­o­gist or clin­i­cal neu­ro­phys­i­ol­o­gist

What is Med­ical Device Reg­u­la­tion, MDR

• The Reg­u­la­tion (EU) 2017/745 on Med­ical Devices (MDR) defines the require­ments for plac­ing med­ical devices on the mar­ket in the EU. The reg­u­la­tion has been in place since May 2021, and it intends to uni­fy the reg­u­la­tion in the EU and fur­ther improve patient safe­ty.
• A Noti­fied Body must assess the manufacturer’s qual­i­ty man­age­ment sys­tem to meet the require­ments of MDR unless the prod­ucts fall into Class I (i.e. the risk lev­el has been esti­mat­ed as rel­a­tive­ly low).
• The man­u­fac­tur­er is required to ensure that the prod­uct has been designed and man­u­fac­tured fol­low­ing the MDR.
• Before the new reg­u­la­tion, med­ical devices were cer­ti­fied under the Med­ical Device Direc­tive (MDD). Any med­ical device on the mar­ket under the MDD cer­ti­fi­ca­tion will have to under­go a tran­si­tion to MDR.

“I’m extreme­ly proud of our team for this sig­nif­i­cant achieve­ment, which high­lights our pro­fes­sion­al­ism and com­mit­ment to pro­vid­ing high-qual­i­ty prod­ucts. Cer­ti­fi­ca­tion under MDR not only enables the long-term sales for C‑Trend® in Europe but also enables its con­tin­u­ous devel­op­ment to new appli­ca­tion areas”, said Juk­ka Kor­te­lainen, CEO and co-founder of Cere­nion.

”This MDR cer­ti­fi­ca­tion process was a chal­leng­ing yet very reward­ing project and I like to thank our Cere­nion team for excel­lent work as well as our Noti­fied Body SGS Fimko for good co-oper­a­tion”, added San­na Hosio, Qual­i­ty and Reg­u­la­to­ry Affairs Direc­tor at Cere­nion.

Source: Cere­nion