T ifo k G oup AGP ess ReleaseAa hus, De ma k, 3 Novembe 2026
(Da ish ve sio attached below)
T ifo k st e gthe s its medical softwa e capabilities with MDR ce tificatio a d CE ma ki g of atio wide medicatio solutio
T ifo k Digital Health has achieved CE ma ki g u de the EU Medical Device Regulatio (MDR) fo Sha ed Medicatio Decisio Suppo t (FMB), developed with the Da ish egio s a d i teg ated i to cli ical systems ac oss De ma k. The solutio suppo ts docto s i maki g decisio s about p esc iptio medicatio . T ifo k Digital Health has also obtai ed MDR ce tificatio f om BSI fo its quality ma ageme t system, suppo ti g its ability to develop egulated medical device softwa e fo othe custome s.
Whe a docto p esc ibes medicatio o eviews a patie t’s medicatio list, FMB ca p ovide patie t-specific decisio suppo t di ectly withi the docto ‘s cli ical system. FMB is desig ed to suppo t cli ical decisio s elati g to the use of p esc iptio medicatio .
What makes FMB disti ctive is that it is ot a sta dalo e cli ical system. I stead, the solutio i teg ates with othe cli ical systems ac oss the healthca e secto a d ca p ovide decisio suppo t di ectly withi the systems healthca e p ofessio als al eady use.
Because FMB suppo ts cli ical decisio s elated to medicatio , the solutio is classified as a Class IIa medical device u de the EU Medical Device Regulatio (MDR).
As pa t of the p ocess, FMB u de we t a co fo mity assessme t with BSI as the otified body. This i cluded a assessme t of the tech ical docume tatio , isk ma ageme t a d cli ical be efits. The CE ma ki g the efo e ep ese ts exte sive wo k o docume tatio a d isk ma ageme t, with a focus o the safe use of the solutio .
“We co g atulate T ifo k Digital Health a d its pa t e s o achievi g CE ma ki g fo FMB u de the Medical Device Regulatio —a impo ta t milesto e i b i gi g i ovative digital health solutio s safely to ma ket,” says Thomas Doe ge, Global Head Active Impla table Medical Devices a d SaMD at BSI.
“Developi g medical softwa e is o lo ge just about fu ctio ality. Today, we must be able to demo st ate to a eve g eate exte t that a solutio pe fo ms co siste tly a d p edictably, that use s ca us it co ectly, a d that pote tial isks a e mo ito ed a d ma aged th oughout the p oduct’s lifecycle,” says Jespe Ca øe, CEO of T ifo k Digital Health.
T ifo k has developed medical device softwa e u de the p evious Medical Devices Di ective (MDD) fo seve al yea s. T ifo k Digital Health has ow obtai ed MDR ce tificatio f om BSI cove i g its quality ma ageme t system fo medical device softwa e developme t, alo gside the CE ma ki g of FMB as Class IIa medical device softwa e.
T ifo k Digital Health is also ce tified to ISO 13485, the i te atio al sta da d fo quality ma ageme t systems fo medical devices. Togethe , these ce tificatio s a d the expe ie ce gai ed th ough FMB p ovide a fou datio fo developi g egulated medical device softwa e fo othe custome s u de MDR. Each p oduct emai s subject to its ow applicable egulato y equi eme ts a d co fo mity assessme t.
“We do ot see the CE ma ki g of FMB as the e d of a p oject. O the co t a y, it p ovides a fou datio we ca build o . Both i the co ti ued developme t of FMB a d i ou wo k o othe digital health solutio s, whe e egulato y equi eme ts eed to be co side ed f om the outset,” says Jespe Ca øe.
FACTS AND BACKGROUND
About Sha ed Medicatio Decisio Suppo t (Fælles Medici Beslut i gsstøtte – FMB)
FMB is a solutio used ac oss the Da ish healthca e secto . It suppo ts docto s by p ovidi g decisio suppo t whe p esc ibi g medicatio to a patie t o eviewi g a patie t’s medicatio list.
Whe FMB is used, patie t-specific data, i cludi g i fo matio about p esc iptio medicatio , is collected a d compa ed with medici al p oduct data a d cli ical guideli es eleva t to the specific p esc iptio . If eleva t decisio suppo t messages a e ide tified, they a e p ese ted to the docto .
The docto emai s espo sible fo maki g the fi al decisio based o thei ow cli ical judgeme t. FMB se ves solely as a decisio suppo t tool.
Without FMB, docto s would eed to et ieve eleva t i fo matio about the patie t, the medicatio a d existi g guideli es f om multiple sou ces. With FMB, this i fo matio ca be delive ed di ectly th ough the docto ‘s chose ge e al p actice system o elect o ic health eco d system.
About CE ma ki g a d MDR
The Medical Device Regulatio (MDR), Regulatio (EU) 2017/745, is the EU egulatio gove i g medical devices, i cludi g softwa e classified as a medical device (MDSW).
The pu pose of MDR is to st e gthe patie t safety th ough equi eme ts elati g to tech ical docume tatio , isk ma ageme t, cli ical evaluatio , usability a d post-ma ket su veilla ce.
FMB is classified as a Class IIa medical device u de MDR.
As a Class IIa medical device, FMB has u de go e a co fo mity assessme t i volvi g BSI as the otified body. As pa t of this assessme t, BSI eviewed, amo g othe thi gs, the tech ical docume tatio , the cli ical evaluatio a d the elatio ship betwee the cli ical evaluatio a d isk ma ageme t.
BSI’s assessme t co cludes, amo g othe thi gs, that the tech ical docume tatio suppo ts complia ce with the eleva t MDR equi eme ts a d that a acceptable bala ce has bee demo st ated betwee the ide tified isks a d the expected cli ical be efits of usi g the solutio .
Pictu e of Jespe G a kæ Ca øe: Li kAbout T ifo k
T ifo k (Nasdaq Cope hage : TRIFOR) is a global tech ology compa y specialisi g i the desig , developme t a d ope atio of adva ced softwa e solutio s fo busi esses a d the public secto . With 1,122 full-time employees ac oss 16 cou t ies, T ifo k se ves as a e d-to-e d tech ology pa t e fo o ga isatio s i complex a d egulated i dust ies, i cludi g public admi ist atio , healthca e, fi a cial se vices, e e gy a d aviatio .
T ifo k develops digital health solutio s a d advises healthca e autho ities, egio s, hospitals, a d life scie ce compa ies. The busi ess a ea combi es softwa e developme t with i -depth k owledge of cli ical wo kflows, i te ope ability, a d i te atio al sta da ds, a d has co t ibuted to solutio s i cludi g Mi Læge, Fælles Medici ko t a d Fælles Medici Beslut i gsstøtte. T ifo k Digital Health is ISO 13485 ce tified a d has ma y yea s of expe ie ce i developi g egulated medical softwa e.
Lea mo e at t ifo k.com.
Co tact
Re é Hauge Sø e se VP & Busi ess Di ecto , T ifo k Digital Health+45 22 69 47 71 hso@t ifo k.com
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