T ans o ma ion o Eu opean Medical De ice
Regula ion: The ole o expe panels
Iana Simo a1, Valen ina Pe ko a2, Sa a Ognyano 3, Milen Dimi o 2
1 Depa men o Ca diology, Hea and B ain Cen e , Ple en, Bulga ian Ca diology Ins i u e, Chai o he Ci cula ion Panel, Expe Panel, Eu opean
Medicines Agency, Ple en, Bulga ia
2 Facul y o Pha macy, Medical Uni e si y – So ia, 2 Duna s . So ia 1000, So ia, Bulga ia
3 Facul y o Chemis y and pha macy, So ia Uni e si y “S . Klimen Oh idski”, So ia, Bulga ia
Co esponding au ho :
Valen ina Pe ko a (pe ko[email p o ec ed]m)
Recei ed
18 Oc obe 2025♦
Accep ed
24 Oc obe 2025♦
Published
18 No embe 2025
Ci a ion:
Simo a I, Pe ko a V, Ognyano S, Dimi o M (2025) T ans o ma ion o Eu opean Medical De ice Regula ion: The ole o
expe panels. Pha macia 72: 1–9. h ps://doi.o g/10.3897/pha macia.72.e175312
Abs ac
The Eu opean Medical De ice Regula ion (MDR) (EU 2017a) and In Vi o Diagnos ic Regula ion (IVDR) (EU 2017b) ep esen a
ans o ma i e shi in medical de ice o e sigh , eplacing ou da ed di ec i es wi h comp ehensi e sa e y and anspa ency equi e-
men s. This e iew analyzes he his o ical con ex d i ing egula o y e o m, including c i ical inciden s in ol ing medical de ices
ha exposed weaknesses in p e ious egula o y amewo ks, and examines he s uc u e and unc ion o expe panels es ablished
by he Eu opean Commission and Eu opean Medicines Agency. These panels p o ide independen scien i ic consul a ions h ough
Clinical E alua ion Consul a ion P ocedu e and Pe o mance E alua ion Consul a ion P ocedu e, suppo ing no i ied bodies in
assessing high- isk de ices while o e ing olun a y ad ice o manu ac u e s. The a icle e alua es he MDR’s impac on manu ac u -
e s, no i ied bodies, pa ien s, heal hca e p o essionals, and ma ke compe i i eness, highligh ing bo h enhanced pa ien p o ec ion
and implemen a ion challenges. Despi e inc eased cos s and ex ended ce i ica ion imelines, he MDR posi ions he EU as a global
leade in medical de ice egula ion, balancing inno a ion wi h igo ous sa e y s anda ds.
Keywo ds
medical de ices, egula ions, expe panels
In oduc ion
Regula ion (EU) 2017/745 on medical de ices – MDR
(EU 2017a) and Regula ion (EU) 2017/746 on in i o
diagnos ic medical de ices – IVDR (EU 2017b), adop -
ed on Ap il 5, 2017, ma k a pi o al momen in he e o-
lu ion o Eu opean medical de ice legisla ion, eplacing
he ou da ed Di ec i e 93/42/EEC (MDD), Di ec i e
90/385/EEC (AIMDD), Di ec i e 98/79/EC (IVDD)
and Commission Decision 2010/227/EU. These eg-
ula ions we e in oduced o add ess he g owing de-
mands o sa e y, e icacy, and anspa ency in a apidly
e ol ing sec o whe e echnological inno a ions and
globaliza ion ha e comple ely ans o med he medical
de ice landscape.
Cen al o hei implemen a ion a e he expe pan-
els o he Eu opean Commission (EC) and he Eu opean
Medicines Agency (EMA), which p o ide scien i ic con-
sul a ions o no i ied bodies o ce ain high- isk medi-
cal de ices, assis manu ac u e s in de eloping inno a i e
solu ions, and con ibu e o ensu ing a high le el o pa-
ien p o ec ion in he EU.
Copy igh Simo a I e al. This is an open access a icle dis ibu ed unde he e ms o he C ea i e Commons A ibu ion License
(CC-BY 4.0), which pe mi s un es ic ed use, dis ibu ion, and ep oduc ion in any medium, p o ided he o iginal au ho and sou ce
a e c edi ed.
Pha macia 72: 1–9
DOI 10.3897/pha macia.72.e175312
Re iew A icle
Simo a I e al.: T ans o ma ion o Eu opean Medical De ice Regula ion2
This e iew a icle aims o analyze he his o ical ea-
sons behind he adop ion o he MDR and IVDR, examine
he s uc u e and equi emen s o he new egula ions, he
ole o he Medical De ice Coo dina ion G oup – MDCG,
de ail he ac i i ies o he expe panels (including he
Clinical E alua ion Consul a ion P ocedu e – CECP, he
Pe o mance E alua ion Consul a ion P ocedu e – PECP,
ad ice o manu ac u e s, suppo o o phan de ices), and
p o ide an analysis o i s in luence on he in e na ional
compe i i eness o he Eu opean ma ke .
His o ical con ex o he
egula ion change
Sho comings o he p e ious di ec i es
The medical de ice legisla ion in pas decades was buil
upon EU di ec i es – AIMDD, MDD, Di ec i e 98/79/EC
and Decision 2010/227/EU. These documen s played an
impo an ole in his pe iod o ha moniza ion o med-
ical de ice egula ions wi hin he union. The egula o y
sys em elied mos ly on manu ac u e sel -decla a ion
and o e sigh by no i ied bodies.
O e ime, howe e , i became clea ha his app oach
was insu icien o add ess he complexi y o mode n de-
ices, such as implan s, so wa e applica ions, and high-
ech diagnos ic sys ems. New egula ions o medical de-
ices and in i o diagnos ics we e d a ed and p oposed
in 2012 (EC 2012) bu public discussions and wo king
g oup e o s on c ea ing a new egula o y amewo k
s a ed in 2008–2009.
In 2010, he Poly Implan P o hèse (PIP) b eas im-
plan scandal was unco e ed when i was e ealed ha
he F ench manu ac u e PIP had used indus ial-g ade
silicone ins ead o medical-g ade ma e ial. This case a -
ec ed o e 300,000 women in Eu ope and led o nume -
ous heal h complica ions, including in lamma ion and
implan up u es (Lampe e al. 2012).
While some au ho s a ibu e he g ea e exposu e o
Eu opean pa ien s o heal h isks o limi a ions o MDD
(Ma indale and Menache 2013), i ’s impo an o ec-
ognize ha he PIP scandal was undamen ally a case
o c iminal aud ha e en he mos obus egula o-
y amewo k could no ha e p e en ed (EC SCENIHR
2013, 2014). The ounde o he PIP, Jean-Claude Mas, was
sen enced o ou yea s in p ison in Decembe 2013 o
using cheap indus ial g ade silicone (The Gua dian 2013)
and TUV Rheinland was ound liable and paid o e 60
millions eu os o a ec ed women (BBC News 2017).
Howe e , a alid c i icism can be made ega ding isk
assessmen : Eu opean au ho i ies ailed o adequa ely ap-
p ecia e he signi icance o his p oduce ’s egula o y his-
o y and i s exclusion om he US ma ke se e al yea s
ea lie . The con as ing p ocesses and ou comes in hese
wo ma ke s canno be a ibu ed simply o egula o y
amewo ks, bu a he s ems p ima ily om how p o-
duc ion con ol measu es we e echnically implemen ed,
wi h he FDA’s cen alized app oach pe o ming mo e e -
ec i ely han he EU’s decen alized model (Ma indale
and Menache 2013).
A pa icula ly illus a i e example is he ecall o he
DePuy ASR hip p os heses in 2010, ollowing he disco e y
ha hei me al componen s gene a ed cy o oxic me allic
deb is wi hin he body, wi h ad e se ou comes documen -
ed in app oxima ely 93,000 pa ien s and equi ing e ision
su ge y o ens o housands o cases (Cohen 2012).
Some esea che s a ibu e his ailu e o egula o y
mechanisms unde he MDD as Eu opean egula o s ailed
o ecognize ha he ASR hip esu acing sys em di e ed
undamen ally om con en ional hip eplacemen de ices.
This o e sigh led o ma ke app o al based solely on limi -
ed simula o -gene a ed da a a he han ex ensi e p eclini-
cal ials. Di e ences in design o he ASR om adi ional
hip eplacemen s esul ed in ad e se de ice-body in e ac-
ions and delayed complica ions in pa ien s (Cohen 2011).
The ques ion emains whe he a small-scale p ema ke
s udy could ha e iden i ied hese p oblems, gi en ha he
p ima y issues in ol ed delayed biocompa ibili y compli-
ca ions a ising om long- e m implan - issue in e ac ions.
Fo ma ke app o al he FDA eques p ema ke s udy da a,
bu he applica ion was wi hd awn by he company la e as
mo e cases o sys emic oxici y we e epo ed (Cohen 2011).
The need o e o m
These wo majo medical de ice scandals could no be
simply cha ac e ized as he main ca alys s o new egu-
la ions as he MDR d a was al eady in p epa a ion, bu
hey demons a ed a p ecisely he igh momen he need
o e o m in ma ke app o al p ocess, pos -ma ke man-
u ac u e con ol and egula o y ame in gene al (Eike -
mann e al. 2013). Fu he mo e, hey unc ioned as a s ess
es o he e o ming egula o y in as uc u e o he EU.
Wi h echnological ad ancemen s and he globaliza-
ion o he medical de ice ma ke , i became e iden ha
he old sys em could no mee new challenges. The eme -
gence o so wa e as a medical de ice (e.g., diagnos ic and
moni o ing applica ions) and he inc ease in high- isk
implan able de ices demanded s ic e sa e y and e ica-
cy s anda ds. Meanwhile, global compe i ion led some
manu ac u e s o use he Eu opean ma ke as a “ es ing
g ound” o de ices wi h insu icien clinical da a be o e
ce i ying hem in s ic e ma ke s like he U.S.
In esponse o his his o ical con ex , he Eu opean Com-
mission ini ia ed a comp ehensi e legisla i e e o m p ocess
(EC 2012) wi h wo p ima y objec i es: i s , o achie e he
highes le el o egula o y ha moniza ion ac oss membe
s a es, and second, o add ess he challenges posed by ap-
id scien i ic and echnological ad ancemen . The e ision
p ocess commenced wi h s akeholde consul a ions as ea ly
as 2008, culmina ing in he 2012 egula o y p oposal ol-
lowing a sys ema ic analysis o mo e han 300 documen ed
medical de ice inciden s occu ing be ween 2005 and 2010.
The main goals o he e o m we e o p e en he ma -
ke en y o de ices wi hou su icien e idence o sa e y
Pha macia 72: 1–9 3
and pe o mance, imp o e pos -ma ke aceabili y, and
s eng hen coo dina ion among Membe S a es h ough a
uni ied and anspa en sys em. These e o s culmina ed
in he adop ion o he MDR and IVDR, which in oduced
s ic e equi emen s and c ea ed mechanisms such as ex-
pe panels p o iding independen opinions and ad ice.
The New Medical De ice
Regula ions (MDR and IVDR)
Legal basis and imeline
The MDR en e ed in o o ce on May 25, 2017, wi h ull
implemen a ion ini ially scheduled o May 26, 2020.
Howe e , he COVID-19 pandemic necessi a ed a one-
yea delay ia (EU 2020), mo ing he new deadline o May
26, 2021. Due o signi ican challenges aced by manu ac-
u e s and no i ied bodies, as well as he isk o medical
de ice sho ages ex ension was adop ed in Ma ch 2023
(EU 2023). This egula ion ex ended he ansi ional pe i-
ods un il Decembe 31, 2027, o high- isk de ices (Class
III and some Class IIb) and un il Decembe 31, 2028, o
lowe - isk de ices, p o ided hey ha e alid MDD o
AIMDD ce i ica es and manu ac u e s ha e aken s eps
o ansi ion o he MDR (Table 1).
Key changes
Expanded scope o egula ion
The MDR signi ican ly b oadens he scope o egula ed
p oduc s, including ca ego ies p e iously unde less s in-
gen o e sigh (Table 2):
MDD had limi ed p o isions on so wa e bu wi h MDR
So wa e as a Medical De ice (SaMD) was included - ap-
plica ions and p og ams used o diagnosis, moni o ing, o
ea men a e quali ied as medical de ices. Complex sys ems
o senso s o measu ing blood suga plus use in e ace on
mobile app o wea able so wa e analyzing hea hy hm all
unde he MDR. This e lec s apid ad ancemen s in dig-
i al heal hca e, wi h he SaMD ma ke p ojec ed o each
€86 billion by 2027. An example is he F eeS yle Lib e app,
which allows diabe ics o moni o glucose le els ia a senso
and sma phone – now equi ing ull MDR ce i ica ion.
Aes he ic De ices wi hou Medical Func ion: P oduc s
like de mal ille s, skin lase de ices, and deco a i e con-
ac lenses a e egula ed due o po en ial heal h isks. Fo
ins ance, imp ope use o a oo emo al lase s can cause
bu ns o in ec ions, and de mal ille s ha e been linked o
complica ions like nec osis when imp ope ly adminis e ed.
Nanoma e ials: De ices con aining nanopa icles, such
as o hopedic implan s o ca he e coa ings, a e classi ied
in o highe - isk ca ego ies due o hei po en ial e ec s
on he body. Nanopa icles can pene a e cells, equi ing
ho ough biocompa ibili y es ing. An example is i ani-
um implan s wi h nanocoa ings ha enhance osseoin e-
g a ion bu equi e addi ional long- e m e ec s udies.
This expanded scope a ec s o e 8,000 p oduc s, en-
hancing consume p o ec ion bu also imposing addi ion-
al equi emen s on manu ac u e s, pa icula ly in digi al
echnology and aes he ic medicine.
S ic e clinical e alua ion equi emen s
The MDR emphasizes clinical e idence o ensu e de ice
sa e y and e icacy:
Long-Te m Clinical S udies: High- isk Class III de ices
(e.g., hea al es, o hopedic implan s) equi e con inu-
ous pos -ma ke clinical ollow-up. This is a signi ican
imp o emen o e he MDD, whe e long- e m s udies
we e a ely manda ed. Fo example, ca diac s en s mus
now demons a e no only sho - e m sa e y and pe o -
mance bu also an accep able a e o la e complica ions
like es enosis o e yea s.
Pos -Ma ke Clinical Follow-Up (PMCF)
The MDR A icle 86 (EU 2017a) manda es con inuous
pos -ma ke moni o ing, including annual epo s (class
III and class IIb implan able de ices). These epo s mus
be submi ed o he compe en au ho i ies and include:
– Sa e y da a analysis
– Risk-bene i e alua ion
– In o ma ion on any co ec i e ac ions aken
– Upda es on clinical e idence
Unique De ice Iden i ica ion (UDI) sys em
The UDI sys em is a key inno a ion imp o ing medical
de ice aceabili y:
• UDI-DI (De ice Iden i ie ): A unique code o each
de ice model, linked o he manu ac u e . Fo exam-
ple, each insulin pump model has i s own UDI-DI.
• UDI-PI (P oduc ion Iden i ie ): A code o speci ic
ba ches o se ial numbe s, enabling indi idual uni
iden i ica ion. This acili a es ecalls o de ec i e
ba ches wi hou a ec ing he en i e p oduc line.
Table 1. MDR T ansi ion Pe iods.
De ice class Deadline Condi ions
High- isk
(Class III)
Dec 31, 2027 Valid MDD ce i ica e, s eps owa d MDR
Low- isk Dec 31, 2028 Valid MDD ce i ica e, s eps owa d MDR
Table 2. Compa ison Be ween MDD and MDR.
Aspec MDD (93/42/EEC) &
AIMDD (90/385/EE)
MDR (2017/745)
Clinical
E alua ion
Limi ed da a In-dep h, con inuous
Scope Medical de ices, limi ed
scope on medical so wa e
Includes aes he ic de ices,
so wa e encompassed
comple ely
T anspa ency No UDI Manda o y UDI and
EUDAMED
Con o mi y
Assessmen
Ligh e p ocess S ic e checks, expe panel
consul a ions
Simo a I e al.: T ans o ma ion o Eu opean Medical De ice Regula ion4
• UDI no only signi ican ly imp o es inciden man-
agemen bu comba s coun e ei de ices, cos ing
billions annually. In he EU, he sys em has helped
iden i y and emo e coun e ei su gical ins u-
men s impo ed om hi d coun ies.
EUDAMED da abase
EUDAMED (EC 2025a) is a cen alized da abase aimed
a inc easing anspa ency and in o ma ion access. I in-
cludes modules o :
– Regis e ing manu ac u e s, au ho ized ep esen a-
i es, and de ices.
– Managing clinical in es iga ions and app o als.
– Repo ing se ious inciden s and co ec i e ac ions.
Al hough ull EUDAMED implemen a ion is delayed
un il Q1 o 2027, pa ial unc ionali y al eady allows
heal hca e p o essionals and pa ien s o check de ice s a-
uses. Fo example, a pa ien wi h an implan ed pacemak-
e can e i y i s egis a ion and ce i ica ion, enhancing
us . Howe e , he delay c ea es empo a y challenges as
much da a emains managed a he na ional le el.
Impac o he MDR on
s akeholde s
Manu ac u e s
The new egula ion has ex ended ime- o-ma ke and in-
c eased inancial and adminis a i e bu dens. These ad-
di ional cos s and delays pose signi ican challenges o
manu ac u e s. Acco ding o a Med ech su ey in 2024,
manu ac u e s aced signi ican ly inc eased clinical ial
cos s a e he MDR’s in oduc ion, e lec ing bo h inan-
cial bu dens and heigh ened quali y ocus (MT EU 2024).
Howe e , he MDR also o e s long- e m bene i s o
manu ac u e s ha success ully adap . Fo example, s ic -
e sa e y and e icacy s anda ds can enhance company ep-
u a ions, which is c ucial in he compe i i e in e na ional
ma ke whe e consume and heal hca e sys em us is key.
One illus a i e case in ol es a manu ac u e o an im-
plan able ca dio e e -de ib illa o (ICD) ha ecei ed
ecommenda ions om an expe panel du ing he in July
2022. The panel ad ised addi ional long- e m eliabili y
da a o he ba e y and elec odes, leading o design mod-
i ica ions be o e ma ke en y. This in e en ion no only
p e en ed po en ial u u e inciden s bu also allowed he
manu ac u e o launch an imp o ed p oduc , s eng hen-
ing i s ma ke posi ion (EC 2022a).
No i ied bodies
No i ied bodies (NB), esponsible o medical de ice ce -
i ica ion, a e also signi ican ly impac ed by he MDR,
wi h new equi emen s leading o changes in hei s uc-
u e, wo kload, and ope a ional p ocesses (EC 2025b).
MDR equi es no i ied bodies o demons a e g ea e
echnical compe ence, employ quali ied pe sonnel, and
conduc mo e de ailed manu ac u e inspec ions, in-
cluding si e audi s. The numbe o NB in he EU d opped
sha ply om 56 in 2017 o 42 by he end o 2023 due o
s ic e acc edi a ion s anda ds unde he MDR, bu o
da e he numbe o ac i e NB unde MDR is 50.
This designa ion p ocess is highly complex and
ime-consuming, and leading some smalle o less-p e-
pa ed o ganiza ions o exi he ma ke . The emaining no-
i ied bodies aced a sha p inc ease in wo kload, as hey
had o p ocess a la ge numbe o ce i ica ion applica ions
unde he new ules wi h limi ed capaci y.
Pa ien s
Pa ien s a e among he p ima y bene icia ies o he MDR,
as he egula ion signi ican ly aises sa e y and anspa -
ency s anda ds, di ec ly impac ing he quali y o medi-
cal de ices eaching hem. S ic clinical e alua ion and
pos -ma ke su eillance equi emen s mean ha ma -
ke ed de ices ha e unde gone igo ous sa e y and e icacy
es ing, educing isks like hose seen in he pas .
Fo example, manda o y UDI use enables apid iden-
i ica ion and ecall o p oblema ic de ices i ad e se
e ec s a ise, signi ican ly imp o ing pa ien p o ec ion
compa ed o he p e ious sys em, which lacked such
aceabili y mechanisms.Addi ionally, public access o he
EUDAMED da abase allows pa ien s and hei amilies o
ob ain in o ma ion abou de ices used in hei ea men
– om in ended use and manu ac u e o epo ed inci-
den s. This inc eases awa eness and us in he heal hca e
sys em, gi ing pa ien s g ea e con idence ha hei de ic-
es ha e passed s ingen checks.
Despi e hese bene i s, ex ended ce i ica ion imelines
may empo a ily limi access o some inno a i e de ices,
which could be p oblema ic o pa ien s needing u gen o
specialized ea men s.
Heal hca e p o essionals
Heal hca e p o essionals a e also a ec ed by he MDR,
wi h he egula ion p esen ing bo h ad an ages and chal-
lenges. A key ad an age is imp o ed access o in o ma ion
ia EUDAMED, enabling hem o check de ice speci ica-
ions, clinical da a, and de ice- ela ed ad e se e ec s.
This acili a es in o med decision-making when selec -
ing app op ia e de ices o pa ien s, especially o high-
isk implan s o diagnos ic sys ems. Fo example, posi i e
expe panel opinion on high- isk implan able de ices
augmen s he con idence among clinicians using such de-
ices in hei p ocedu es on pa ien s.
A he same ime, he MDR’s new equi emen s neces-
si a e amilia i y wi h mo e complex acking and epo -
ing sys ems like UDI and EUDAMED, equi ing ime o
aining and adap a ion. This p ocess may be pa icula ly
challenging o smalle hospi als o egions wi h limi ed
esou ces, whe e s a a e al eady bu dened wi h clini-
Pha macia 72: 1–9 5
cal du ies. Addi ionally, empo a y delays in new de ice
app o als may limi p o essionals’ access o cu ing-edge
echnologies, po en ially a ec ing ca e quali y, especially
in apidly e ol ing ields like minimally in asi e su ge y
o pe sonalized medicine.
Eu opean Adminis a ion (EC and EMA)
The Eu opean adminis a ion, including he Eu opean
Commission and he Eu opean Medicines Agency, plays
a key ole in implemen ing he MDR and is also impac -
ed by i s consequences. The MDR ha monizes egula ions
ac oss he EU, eplacing p e ious na ional a ia ions wi h
a uni ied amewo k, simpli ying o e sigh and coo dina-
ion among membe s a es.
The EUDAMED da abase, managed by he EC, p o-
ides a cen alized ool o moni o ing medical de ices on
he ma ke , enabling he adminis a ion o quickly iden i-
y p oblema ic de ices and ake ac ion, such as ecalls o
imposing addi ional equi emen s. This signi ican ly en-
hances he EC’s abili y o p o ec public heal h compa ed
o he p e ious agmen ed sys em, whe e each membe
s a e had i s own inciden epo ing and esponse p oce-
du es.
The EMA, meanwhile, suppo s he p ocess by o ga-
nizing and managing expe panels ha p o ide scien i ic
opinions on high- isk de ices. This new app oach, how-
e e , equi es signi ican adminis a i e esou ces, s a
aining, and panel coo dina ion. Despi e hese cos s, he
bene i s o enhanced ma ke sa e y and anspa ency a e
subs an ial, wi h he MDR posi ioning he EU as a leade
in global medical de ice egula ion s anda ds.
The Eu opean ma ke
The Eu opean medical de ice ma ke , one o he wo ld’s
la ges , aces mixed consequences om he MDR, wi h
he balance be ween enhanced sa e y and empo a y in-
no a ion challenges a he o e on . On one hand, s ic e
clinical e alua ion and ce i ica ion equi emen s ensu e
ha only de ices wi h p o en sa e y and e icacy each he
ma ke , boos ing consume and heal hca e sys em con-
idence in Eu opean p oduc s. This may s eng hen he
EU’s posi ion as a supplie o high-quali y medical de ices
globally.
On he o he hand, ex ended ce i ica ion imelines
(18–24 mon hs compa ed o he p e ious 12) delay new
de ice launches, which is pa icula ly p oblema ic in
as -e ol ing ields like ca diology, oncology and neu olo-
gy. Fo example, inno a i e de ices like adio he apy ma-
chines o neu os imula o s, which could imp o e cance
o neu odegene a i e disease ea men , o en emain in
ce i ica ion limbo longe han pa ien s need.
This delay may lead o a empo a y decline in new ech-
nology a ailabili y, pu ing he EU a a disad an age com-
pa ed o ma ke s like he U.S., whe e app o al p ocesses
a e as e . In he long e m, howe e , highe s anda ds
may a ac mo e in es men o he Eu opean sec o , as
manu ac u e s ocus on de eloping high-quali y de ices
mee ing MDR equi emen s.
As his phenomenon was pa ially ela ed o he e-
duced numbe o no i ied bodies, now as hey ha e e-
u ned o p e-MDR le els and mos o he ansi ion p o-
cesses a e comple ed we could expec he imelines o be
sho ened and his o ha e a posi i e impac on he EU
ma ke .
Focus on he wo k o expe panels
The expe panels es ablished unde MDR and IVDR a e a
key componen o he new egula o y amewo k, wi h hei
p ima y goal being o p o ide independen , high-quali y
scien i ic opinions on no i ied bodies’ assessmen s o high-
isk medical de ices and in i o diagnos ic de ices.
They ope a e unde he coo dina ion o he Eu opean
Commission (EC) and he Eu opean Medicines Agency
(EMA), p o iding consul a ions o no i ied bodies du ing
con o mi y assessmen s and ad ising manu ac u e s on
de eloping inno a i e solu ions.
S uc u e and ole
The expe panels a e o ganized in o a complex ye well-co-
o dina ed s uc u e ensu ing de ice assessmen s a e con-
duc ed by specialis s wi h deep expe ise in ele an ields.
They consis o h ee main componen s: a sc eening panel,
hema ic panels, and a coo dina ion commi ee.
Sc eening Panel: Ac s as an ini ial il e , e iewing all
applica ions om no i ied bodies and de e mining whe h-
e a de ice equi es u he e alua ion by a specialized
hema ic panel. This p ocess is c i ical o a oid unnec-
essa y sys em o e load and ocus esou ces on he high-
es - isk de ices.
Thema ic Panels: The co e o he s uc u e, co e ing all
majo medical disciplines and comp ising ele en special-
ized g oups (Fig. 1.):
– Ca dio ascula De ices (e.g., s en s, pacemake s,
hea al es).
– O hopedics, T auma ology, Rehabili a ion, Rheu-
ma ology (e.g., p os heses, join implan s).
– Neu ology (e.g., neu os imula o s, b ain implan s).
– Respi a o y Sys em, Anes hesiology, In ensi e Ca e
(e.g., en ila o s, oxygen sys ems).
– Endoc inology and Diabe es (e.g., insulin pumps,
glucose moni o s).
Figu e 1. The co e o he s uc u e, co e ing all majo medi-
cal disciplines and comp ising ele en specialized g oups.
Simo a I e al.: T ans o ma ion o Eu opean Medical De ice Regula ion6
– Gene al and Plas ic Su ge y, Den al Medicine (e.g.,
su gical ins umen s, aes he ic de ices).
– Obs e ics and Gynecology (e.g., in au e ine de ic-
es, e al moni o s).
– Gas oen e ology and Hepa ology (e.g., endoscopes,
gas ic balloons).
– Neph ology and U ology (e.g., dialysis machines,
enal implan s).
– Oph halmology (e.g., in aocula lenses, lase sys ems).
– Pedia ics and a e diseases.
A wel h panel is dedica ed o in i o diagnos ic de-
ices, ocusing on high- isk es s like hose o in ec ious
diseases o gene ic ma ke s. Coo dina ion Commi ee:
Ensu es me hodological consis ency and s anda ds ac oss
panels, acili a ing in o ma ion exchange and main aining
o e all ha mony in hei wo k.
Panel expe s a e selec ed h ough a igo ous public
p ocess o ganized by he EMA, equi ing high scien i ic
quali ica ions and clinical expe ience o ensu e opinion
quali y. Thei main ole is o enable consul a ion p o-
cedu es o no i ied bodies on he sa e y and e icacy o
high- isk de ices, he eby aising s anda ds ac oss he EU.
Clinical E alua ion Consul a ion P oce-
du e (CECP)
The CECP ep esen s a c i ical egula o y mechanism de-
signed o ensu e ha he highes - isk medical de ices unde -
go independen scien i ic sc u iny be o e eaching pa ien s
MDR A icle 54 (EU 2017). This p ocedu e ope a es as a
manda o y sa egua d o speci ic de ice ca ego ies whe e he
po en ial consequences o inadequa e clinical e idence could
ha e se e e implica ions o pa ien sa e y and public heal h.
Manda o y Applica ion Scope: The CECP applies wi h
absolu e equi emen o all Class III implan able de ices,
ecognizing ha hese de ices p esen he highes le el o
isk due o hei pe manen o long- e m placemen wi h-
in he human body and hei c i ical he apeu ic unc-
ions. Addi ionally, ce ain Class IIb de ices all unde
his equi emen , speci ically ac i e he apeu ic de ices
ha adminis e o emo e medicinal p oduc s.
This expansion o include ac i e emo al and adminis-
a ion de ices e lec s he egula o y sys em’s ecogni ion
ha de ices which ac i ely manipula e d ug deli e y o
emo al ca y inhe en isks ha wa an enhanced sc u-
iny ega dless o hei adi ional classi ica ion bounda -
ies. The wo k low o CECP is ou lined in Fig. 2.
The p ocedu e ensu es ha no i ied bodies canno
p oceed wi h ce i ica ion decisions in isola ion bu mus
inco po a e independen scien i ic e alua ion om ex-
pe panels in o hei assessmen p ocess. This c ea es a
dual-laye e iew sys em whe e bo h echnical egula o y
compliance and independen scien i ic alida ion mus
align be o e ma ke au ho iza ion.
S a is ical pe o mance analysis and egu-
la o y ends
Implemen a ion esul s o he pe iod 2021–2022 we e
published in la e 2022 (EC 2022a). Du ing his ini ial im-
plemen a ion pe iod, no i ied bodies submi ed 215 no i-
ica ions unde A icle 54(3), ep esen ing all po en ially
applicable de ices. O hese submissions, only 24 de ices
(11.2%) ac ually equi ed CECP applica ion, wi h he as
majo i y (191 de ices, 88.9%) quali ying o exemp ion
unde A icle 54(2)(b). This pa e n sugges s ha mos
high- isk de ices ei he had su icien equi alence e i-
dence o did no p esen no el echnology conce ns e-
qui ing expe consul a ion.
Among he 24 de ices ha unde wen CECP sc een-
ing, expe panels decided o p o ide ull opinions o
only 6 applica ions (25.0%). This ela i ely low a e o ull
expe consul a ion indica es ha he sc eening p ocess
e ec i ely iden i ies cases whe e independen scien i ic
inpu p o ides he g ea es egula o y alue (EC 2022b).
Second epo encompasses he pe iod 2022–2023 his
second implemen a ion pe iod showed inc eased no i i-
ca ion olume wi h 353 submissions unde A icle 54(3),
e lec ing g owing amilia i y wi h he p ocess and po-
en ially inc eased de ice submissions. The p opo ion
equi ing CECP applica ion emained consis en a 36 de-
ices (10.2%), sugges ing s able egula o y pa e ns as he
sys em ma u ed (EC 2023).
The exemp ion pa e ns in he second pe iod showed
e en s onge concen a ion unde A icle 54(2)(b), wi h
314 o 317 exemp ed de ices (99.1%) quali ying unde
his p o ision. This concen a ion indica es ha equi a-
lence-based exemp ions emain he p ima y pa hway o
a oiding CECP consul a ion.
Among de ices unde going CECP sc eening in he
second pe iod, expe panels p o ided opinions o only
4 o 35 applica ions (12.0%), showing a dec eased a e
compa ed o he i s pe iod. This educ ion migh e lec
imp o ed sc eening e iciency o mo e app op ia e appli-
ca ion o exemp ion c i e ia by no i ied bodies.
Pe o mance E alua ion Consul a ion
P ocedu e (PECP)
The PECP mi o s he CECP bu is speci ic o high- isk
in i o diagnos ic de ices (Class D), such as es s o in-
ec ious diseases (e.g., HIV, hepa i is) o gene ic ma ke s
o se ious condi ions. In oduced unde he IVDR, his
p ocedu e ensu es ha c i ical diagnos ic de ices a e ac-
cu a e and eliable.
Ga eway C i e ia: The de ice mus i s quali y as a
Class D (EU 2022) in i o diagnos ic de ice acco ding
Figu e 2. The wo k low o CECP.
Pha macia 72: 1–9 7
o he classi ica ion ules ou lined in Annex VIII o he
IVDR (EU 2017b). Class D ep esen s he highes isk
ca ego y o IVDs, encompassing de ices ha de ec
li e- h ea ening condi ions, blood sc eening applica ions,
o companion diagnos ics ha di ec ly in luence c i ical
ea men decisions.
The PECP equi es ha manu ac u e s and no i ied
bodies sa is y bo h igge condi ions simul aneously. The
i s condi ion equi es he absence o Common Speci ica-
ions o he speci ic class D de ice unde e iew. The sec-
ond condi ion ocuses on he concep o “ i s ce i ica ion
o ha ype o de ice”.
Requi ed Documen a ion includes he Comple e Pe -
o mance E alua ion Repo add essing scien i ic alid-
i y, analy ical pe o mance, and clinical pe o mance.
IVDR-Enhanced Risk Managemen Documen a ion ep-
esen s a signi ican depa u e om adi ional ISO 14971
app oaches, equi ing comp ehensi e bene i - isk analysis
o all iden i ied isks.
By he end o 2024, acco ding o EMA annual epo ,
o al o 21 PECP we e pe o med by in i o diagnos ics
expe panel. (EMA 2024a)
Ad ice o manu ac u e s
In addi ion o manda o y consul a ions, expe panels
p o ide olun a y ad ice o high- isk de ice manu ac u -
e s, pa icula ly use ul o companies de eloping inno-
a i e echnologies o add essing unme medical needs
(EMA 2024b).
This p ocedu e was in oduced in 2023 as a pilo com-
ple ed in Decembe 2024. Based on he success ul ou -
come, he ad ice o manu ac u e s was ully implemen -
ed as o Feb ua y 2025. Imp o emen s o he p ocedu e
we e made conside ing he eedback ecei ed om bo h
expe s and manu ac u e s du ing he pilo .
The ad ice aims o assis manu ac u e s ea ly in de el-
opmen , be o e o mal con o mi y assessmen , o e ing
guidance on clinical s udy design, endpoin selec ion, and
p epa a ion o mee MDR equi emen s.
The pilo phase p io i ized ce ain ypes o medical de-
ices:
– De ices ha bene i a small g oup o pa ien s in he
ea men o diagnosis o a disease o condi ion,
such as de ices in ended o he ea men o a a e
condi ion, known as ‘o phan de ices’, and de ices
o paedia ic use;
– De ices add essing medical condi ions ha a e li e
h ea ening o cause pe manen impai men o a
body unc ion and o which cu en medical al e -
na i es a e insu icien o ca y signi ican isks;
– No el de ices wi h a possible majo clinical o
heal h impac .
In o al, 51 le e s o in e es we e ecei ed: 26 o he i s
phase, 16 o he second phase, and 9 o he hi d phase.
75% o applican s declai ed mee ing he SME de ini-
ion. The majo i y o he applica ions ecei ed we e o
de ices ha we e conside ed no el wi h a possible majo
clinical o heal h impac (c i e ion decla ed by 86% o ap-
plican s) ollowed by de ices add essing an unme medi-
cal need (c i e ion decla ed by 55% o applican s).
The Ci cula o y sys em hema ic panel ecei ed he
highes numbe o applica ions wi h 31% o applica ions,
ollowed by he O hopaedics, auma ology, ehabili a ion,
heuma ology hema ic panel (27%) hen Neu ology (14%).
Role o he Medical De ice Coo dina ion
G oup (MDCG)
The MDCG, es ablished unde he MDR (EU 2017a),
plays a i al ole in main aining ha moniza ion and con-
sis ency in he egula ion’s implemen a ion, including ex-
pe panel ac i i ies.
Comp ising Membe S a e ep esen a i es and chai ed
by he EC, he MDCG de elops guidelines and ecom-
menda ions aiding no i ied bodies, manu ac u e s, and
expe panels in in e p e ing and applying MDR equi e-
men s – p o iding guidance on clinical e alua ion o
high- isk de ices, cla i ies so wa e classi ica ion c i e ia
and e c. These guidelines a e c ucial o expe panels, en-
su ing s anda dized, compa able e alua ions ac oss he-
ma ic a eas.
O phan de ice s a us
Expe panels also suppo medical de ices o a e dis-
eases, a ec ing ewe han 12,000 annual cases in he EU
(~5 pe 10,000 people).
These “o phan de ices” a e c i ical o pa ien s wi h
unme medical needs, bu hei de elopmen aces high
cos s and challenges due o small po en ial use bases. The
MDR o e s incen i es like educed consul a ion ees and
accele a ed e alua ions, wi h expe panels p o iding spe-
cialized suppo h ough ad ice and clinical da a assess-
men .
Fo example, he endoc inology panel migh p o ide
an opinion ega ding he o phan s a us and p o ide sci-
en i ic ad ice on clinical de elopmen on a new a e me -
abolic diso de moni o ing de ice, sugges ing app op ia e
da a collec ion me hods o limi ed pa ien popula ions.
In e na ional compe i i eness
The in oduc ion o MDR signi ican ly impac ed he in-
e na ional compe i i eness o he Eu opean medical de-
ice ma ke , p esen ing bo h challenges and oppo uni ies
o Eu opean manu ac u e s compa ed o leading ma ke s
like he U.S. and Asia.
As he MDR imposes signi ican ly s ic e clinical
e alua ion, aceabili y, and pos -ma ke su eillance e-
qui emen s his almos doubles he ime needed his o i-
cally unde di ec i es, acco ding o Med ech epo 2024
(MT 2024). On he o he hand, FDA’s app o al p ocess
allows manu ac u e s o ma ke de ices much as e i
hey demons a e subs an ial equi alence o an al eady
app o ed de ice.
Simo a I e al.: T ans o ma ion o Eu opean Medical De ice Regula ion8
This delay leads o a empo a y decline in he speed
o new de ice launches in he EU, pu ing Eu opean
manu ac u e s a a disad an age agains U.S. compe i-
o s who can deli e inno a ions o ma ke as e . This
gap is pa icula ly sensi i e in as -e ol ing sec o s like
oncology and pe sonalized medicine, whe e imely ac-
cess o new echnologies can be c i ical o bo h pa ien s
and ma ke success.
Despi e hese challenges, he MDR also o e s signi -
ican ad an ages ha may s eng hen Eu opean manu-
ac u e s’ in e na ional compe i i eness long- e m. Fi s ,
uni o m sa e y and pe o mance equi emen s le el he
playing ield o all companies en e ing he EU ma ke ,
whe he Eu opean o in e na ional. The MDR’s high s an-
da ds may gi e Eu opean companies a compe i i e edge
in ma ke s aluing quali y o e speed.
Acco ding o MedTech Eu ope epo 2023 (MT 2023),
abou 15% o hese companies isk bank up cy o ma -
ke exi due o inabili y o mee new equi emen s. On
he o he hand, long- e m bene i s om enhanced us
and quali y may inc ease Eu opean de ice ma ke sha e
in p emium segmen s, like high- ech implan s and diag-
nos ic sys ems.
Conclusion
MDR and i s associa ed expe panels ep esen a ans-
o ma i e momen in Eu opean medical de ice egula-
ion, add essing long-s anding gaps in p e ious di ec-
i es h ough s ic e sa e y, e icacy, and anspa ency
equi emen s. His o ical inciden s like he PIP implan
and DePuy p os hesis scandals se ed as a s ess es o
he exis ing legal p oposals, and ul ima ely e inced he
need o e o m, which he MDR success ully deli e s
ia enhanced clinical e alua ion, imp o ed aceabili-
y h ough UDI and EUDAMED, and he independen
ole o expe panels. These panels, wi h hei complex
s uc u e and specialized hema ic g oups, p o ide sci-
en i ic suppo o no i ied bodies and manu ac u e s,
ensu ing high- isk de ices mee he highes s anda ds
p e- and pos -ma ke . P ocedu es like he CECP and
PECP, combined wi h olun a y manu ac u e ad ice
and a e disease de ice suppo , demons a e he EU’s
commi men o pa ien p o ec ion while os e ing sec-
o inno a ion.
Howe e , he MDR also b ings challenges ha can-
no be o e looked. Fo manu ac u e s, highe cos s and
ex ended ce i ica ion imelines c ea e inancial and lo-
gis ical di icul ies, especially o SMEs, he backbone
o he Eu opean indus y. No i ied bodies, educed in
numbe and acing inc easing wo kloads, s uggle o p o-
cess g owing applica ion olumes, delaying new de ice
launches. Pa ien s and heal hca e p o essionals bene i
om enhanced sa e y and in o ma ion access, bu empo-
a y limi a ions on inno a i e echnologies may impac
ca e quali y in some a eas. The Eu opean ma ke gains
us and quali y ad an ages bu isks lagging in inno a-
ion speed agains ma ke s like he U.S. and Asia.
Long- e m MDR success will depend on se e al ac-
o s. Fi s , op imizing ce i ica ion p ocesses, including
expanding no i ied body and expe panel capaci y, will
be c i ical o educing delays. Second, suppo ing SMEs
h ough inancial incen i es o s eamlined p ocedu es
may p e en losing inno a i e po en ial. Thi d, in e na-
ional ecogni ion o MDR s anda ds could s eng hen
he EU’s global leade ship posi ion, a ac ing in es men s
and easing Eu opean de ice en y in o o he ma ke s. Fu-
u e e alua ions, like he EC’s planned 2026 a ge ed s udy
on MDR e ec s, will p o ide clea e long- e m impac in-
sigh s and help ine- une he sys em. In conclusion, he
MDR and expe panels ep esen an ambi ious, necessa y
leap o wa d in public heal h p o ec ion while laying he
ounda ion o sus ainable Eu opean medical de ice in-
dus y g ow h on a global scale.
Addi ional in o ma ion
Con lic o in e es
The au ho s ha e decla ed ha no compe ing in e es s exis .
E hical s a emen s
The au ho s decla ed ha no clinical ials we e used in he p es-
en s udy.
The au ho s decla ed ha no expe imen s on humans o hu-
man issues we e pe o med o he p esen s udy.
The au ho s decla ed ha no in o med consen was ob ained
om he humans, dono s o dono s’ ep esen a i es pa icipa -
ing in he s udy.
The au ho s decla ed ha no expe imen s on animals we e
pe o med o he p esen s udy.
The au ho s decla ed ha no comme cially a ailable immo -
alised human and animal cell lines we e used in he p esen s udy.
Use o AI
No use o AI was epo ed.
Funding
No unding was epo ed.
Au ho con ibu ions
All au ho s ha e ead and ag eed o he published e sion o he
manusc ip .
Au ho ORCIDs
Iana Simo a h ps://o cid.o g/0000-0002-3458-3684
Valen ina Pe ko a h ps://o cid.o g/0000-0002-6938-1054
Sa a Ognyano h ps://o cid.o g/0009-0007-5134-1445
Milen Dimi o h ps://o cid.o g/0000-0002-7744-0384
Da a a ailabili y
All o he da a ha suppo he indings o his s udy a e a ailable
in he main ex .
Pha macia 72: 1–9 9
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