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RESUMO
In odução: Os disposi i os médicos são ecnologias de saúde com um signi ica i o c escimen o a ní el mundial. Foi obje i o des e
abalho analisa os ale as sob e disposi i os médicos emi idos pela Agência Po uguesa do Medicamen o: INFARMED, I.P. du an e
2017, iden i ica as espe i as ações egula ó ias e suge i ecomendações.
Ma e ial e Mé odos: Todos os ale as e ações sob e disposi i os médicos publicamen e disponí eis no websi e do INFARMED, I.P.
o am iden i icados e analisados. Adicionalmen e, os ela ó ios da au o idade compe en e nacional sob e disposi i os médicos o am
compa ados com ela ó ios de ou os países da União Eu opeia como a Alemanha.
Resul ados: Iden i icou-se um o al de 32 ale as de segu ança de disposi i os médicos: 18 (56%) sem egis os de come cialização
em Po ugal, seis (19%) olun a iamen e e i ados do me cado, como p odu os con a ei os, e oi o (25%) ca ego izados como ‘ou os’.
Em Po ugal e na Alemanha o am iden i icados 0,28 e 4,53 ela ó ios de au o idades compe en es po milhão de habi an es, espe i-
amen e. Di e sas ações egulamen a es o am omadas, como seis indicações ob iga ó ias pa a não adqui i ou u iliza disposi i os
médicos.
Discussão: Conside ando que a União Eu opeia é um me cado abe o no qual os cidadãos de êm igual acesso à u ilização de dis-
posi i os médicos, o sis ema Po uguês de ale as de segu ança sob e es es disposi i os pa ece e uma a i idade no mal. Os ale as
de segu ança iden i icados apa en am se ele an es, com Po ugal a egis a um núme o ligei amen e in e io de ale as quando
p opo cionalmen e compa ado com ou os me cados de maio olume de endas, o que e en ualmen e pode se explicado po uma
subno i icação des e ipo de p oblemas. São necessá ios es udos adicionais pa a con i ma es es esul ados p elimina es, sendo o
desen ol imen o de bases de dados sob e o uso de disposi i os médicos pelos doen es ecomendado de o ma a ge a emails e
ale as ele ónicos au omá icos.
Conclusão: Foi iden i icado um núme o limi ado de ale as de segu ança em disposi i os médicos em Po ugal, com escassas no i-
icações de con a ação ou alsi icação. A Agência Po uguesa de Medicamen os con ibui pa a o acesso dos cidadãos a disposi i os
médicos de qualidade, a a és da emissão de ale as de segu ança, ecomendações e e i ada ob iga ó ia de disposi i os médicos
Analysis o Medical De ice Ale s Issued by he
Po uguese Medicines Agency: Scoping he Pu pose o
New Regula o y Recommenda ions
Análise dos Ale as Sob e os Disposi i os Médicos
Emi idos pela Agência Po uguesa do Medicamen o:
Delineando o P opósi o de No as Recomendações
Regula ó ias
1. Resea ch Cen e o Biosciences and Heal h Technologies. Uni e sidade Lusó ona. Lisboa. Po ugal.
2. Depa amen o de Sócio-Fa mácia. Faculdade de Fa mácia. Uni e sidade de Lisboa. Lisboa. Po ugal.
 Au o co esponden e: Ca la Pi es. [email p o ec ed]
Recebido: 11 de janei o de 2020 - Acei e: 12 de maio de 2020 - Online issue published: 01 de ma ço de 2021
Copy igh © O dem dos Médicos 2021
Ca la PIRES1, Dinah DUARTE1, A onso CAVACO2
Ac a Med Po 2021 Ma ;34(3):201-208 ▪ h ps://doi.o g/10.20344/amp.13419
ABSTRACT
In oduc ion: Medical de ices a e heal hca e echnologies wi h a signi ican ly g owing ma ke wo ldwide. This s udy aims o analyze
medical de ice ale s issued by he Po uguese Medicines Agency, INFARMED, I.P. du ing 2017, as well as o iden i y he espec i e
egula o y ac ions and o sugges addi ional ecommenda ions.
Ma e ial and Me hods: All ale s on medical de ice ale s publicly a ailable in he websi e o INFARMED, I.P. we e iden i ied and
analyzed, including ac ions aken. Addi ionally, epo s on medical de ices om he Po uguese na ional compe en au ho i ies we e
compa ed wi h epo s om o he Eu opean Union membe s a es such as Ge many.
Resul s: A o al o 32 sa e y ale s we e iden i ied: 18 (56%) ela ed wi h de ices wi hou iden i ied eco ds o comme cializa ion in Po -
ugal, six (19%) ela ed wi h de ices olun a ily wi hd awn om he ma ke , such as coun e ei p oduc s, and eigh (25%) ca ego ized
as ‘o he ’. In bo h Po ugal and Ge many, 0.28 and 4.53 epo s o na ional compe en au ho i ies pe million inhabi an s we e iden i ied,
espec i ely. Di e se egula o y ac ions we e aken, such as six compulso y indica ions o no acqui e o use de ices.
Discussion: Conside ing ha he Eu opean Union is an open ma ke whe e ci izens should ha e equal access o medical de ices, he
Po uguese sys em o medical de ice sa e y ale s seems o be unc ioning no mally. The iden i ied sa e y ale s seemed ele an , wi h
Po ugal egis e ing a p opo ionally sligh ly lowe numbe o ale s when compa ed wi h highe sales olume ma ke s, which may be
explained by an unde epo ing o his ype o p oblems. Fu he s udies a e needed o con i m hese p elimina y esul s, al hough he
de elopmen o da abases comp ising da a on pa ien s using medical de ices is ecommended in o de o gene a e au oma ic email
and ex message ale s.
Conclusion: A limi ed numbe o sa e y ale s on medical de ices was iden i ied in Po ugal, wi h ew epo ed cases o coun e ei o
alsi ied de ices. The Po uguese Medicines Agency con ibu es o he ci izens’ access o quali y medical de ices, by issuing sa e y
ale s, ecommenda ions and manda o y ma ke wi hd awals o unsui able o unsa e medical de ices.
Keywo ds: Equipmen and Supplies; Pa ien Sa e y/legisla ion & ju isp udence
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Re is a C ie n í ic a d a O de m do s M édi co s ww w.ac am ed ic a po u gu es a.c om
Pi es C, e al. Medical de ice ale s in Po ugal, Ac a Med Po 2021 Ma ;34(3):201-208
INTRODUCTION
The Po uguese Law-Dec ee 145/2009 is based on he
co esponding Eu opean Union (EU) di ec i e 93/42/EEC.1
This Law-Dec ee de ines a medical de ice (MD) as “any
ins umen , appa a us, appliance, equipmen , ma e ial o
ano he a icle, whe he used alone o in combina ion, in-
cluding he so wa e necessa y o i s p ope applica ion
in ended by he manu ac u e , o be used o human be-
ings o he pu pose o diagnosing, p e en ing, con olling,
ea ing o a enua ing a disease; diagnosing, con olling,
ea ing, a enua ing o compensa ing o a lesion o a de i-
ciency; s udying, subs i u ing o al e ing he ana omy o one
physiologic p ocess; and bi h con ol.”
MDs a e classi ied as (i) MDs o class I o low- isk de-
ices (e.g., diape s, incon inence pads, elas ic s ockings,
walking aids, e c.); (ii) MDs wi h a medium isk belong o
classes IIa (e.g., hyd ophilic gauze, u ina y ca he e s, sy-
inges, e c.) o IIb (e.g., insulin pens, diaph agms, con ac
lenses), wi h a likely highe isk in IIb when compa ed wi h
IIa; and (iii) MDs o class III o MDs o high isk (e.g., con-
doms wi h spe micides, in au e ine de ice ha does no
elease p oges ogens, e c.). This classi ica ion is based on
isk c i e ia, such as he ime, deg ee o loca ion o con ac
be ween a MD and he human body, since some MDs a e
mo e in asi e han o he s o a e mean o ch onic use.2
Conside ing he egula ion 2017/746 o he Eu opean Pa -
liamen and o he Council o he 5 h Ap il 2017 on in i o
diagnos ic medical de ices (p elimina y poin 10): “all es s
ha p o ide in o ma ion on he p edisposi ion o a medical
condi ion o a disease, such as gene ic es s, and es s ha
p o ide in o ma ion o p edic ea men esponse o eac-
ions, such as companion diagnos ics, a e in i o diagnos-
ic MDs”.3
Addi ionally, MDs mus ha e a con o mi é eu opéenne
(CE) ma k, which is a con o mi y sign p o ing he de ice
is complian wi h he ele an di ec i es. De ices wi h his
ma k may be ma ke ed in any EU coun y.1-4 The con o mi y
assessmen p ocedu es o MDs may be ca ied ou unde
he esponsibili y o he manu ac u e s o Class I de ices
(gene al ule). Class IIa de ices equi e he in e en ion o a
no i ied body (NB), i.e. bodies esponsible o he con o mi y
assessmen o MDs a e p oduc ion. NBs a e designa ed
by he EU membe s a es and each membe s a e shall
no i y he Commission, as well as he emaining membe
s a es abou he designa ed bodies. NBs may ask he man-
u ac u e o in o ma ion o da a o es ablishing/main ain-
ing he a es a ion o con o mi y o MDs. Classes IIb and III
necessa ily equi e he inspec ion by a NB conce ning he
design and manu ac u e o MDs. Class III p oduc s explici ly
equi e p io au ho iza ion ega ding con o mi y be o e be-
ing placed on he ma ke .1
In he EU, he ma ke o MDs comp ises a ound 27 000
companies: 95% small and medium-sized en e p ises, wi h
g ea inno a ion e o s: on a e age, a new pa en is issued
e e y 40 minu es and he p oduc li ecycle is app oxima ely
o 18 mon hs. These companies employ o e 675 000 wo k-
e s, pa icipa ing in a g owing ma ke (o e €110 billion).
The key end o MD indus ies on cos e iciency is based
on he compulso y c ea ion o alue o paye s and pa ien s,
which is in ended o ensu e ha use s o MDs bene i in
e ms o he p oduc ’s e icacy, sa e y, e iciency, and cos .
Fo ins ance, Aus alian impo e s a e speci ically o ien ed
o acqui e cos -e ec i e MDs, which can imp o e pa ien
heal h ou comes and educe heal hca e cos s due o he
inc easing numbe o an aging popula ion.5
The egula ions on MDs co e di e se aspec s o p od-
uc de elopmen and igilance sys ems, om design o
manu ac u e, clinical es ing, au ho iza ion and pos -ma ke
su eillance.6 Al hough pos -ma ke ing su eillance is es-
sen ial in he de ec ion o non-con o mi ies, quali y issues,
ad e se e en s, o he p esence o alsi ied de ices in he
ma ke ,7,8 a speci ic pos -ma ke su eillance sys em o
medical de ices was only de ined h ough a ecen /new
Eu opean Commission egula ion (EC 2017/745) on medi-
cal de ices in he EU (Chap e VII).9 The 520/2012 EC
Regula ion es ablished a speci ic pha maco igilance sys-
em o medicinal p oduc s,10 al hough a p e ious Council
Di ec i e (93/42/EEC) s a ed ha he p o ec ion o heal h
and he associa ed con ols should be mo e e ec i e by
means o medical de ice igilance sys ems, in eg a ed a
Communi y le el.1,9 In his sense, he Eu opean Da abase
on Medical De ices (EUDAMED) is he in o ma ion sys em
o exchanging legal in o ma ion ela ed o he applica ion o
EU Di ec i es on MDs.7,11,12
Acco ding o he publicly a ailable in o ma ion o he
EU, he o e all numbe o egis e ed ad e se MD e en s
has been s able o he las i e yea s, despi e he cons an
ma ke g ow h.12
In Po ugal, i he ollowing no i ica ions o inciden s and
sa e y co ec i e ac ions ela ed o MDs a e epo ed in he
o icial medicines s a is ics om INFARMED, I.P. (n = MDs
egis e ed/no i ied un il he end o he yea ): 1542 (n = 199
823) in 2014, 1479 (n = 207 443) in 2015, 1790 (n = 226
948) in 2016, 1645 (n = 244 138) in 2017 and 1741 (n = 277
834) in 2018.13
Conside ing he NCAR (Na ional Compe en Au ho i ies
Repo s) om 17 EU coun ies, a o al o 981 ele an e en s
wi h MDs we e no i ied in 2017.7,12 NCARs a e “in ended o
dissemina ion be ween Na ional Compe en Au ho i ies and
he Commission”; hei quali a i e in o ma ion is no public.
NCAR should be c ea ed in acco dance wi h a egula ed
o m/ empla e: “This o m should be comple ed by NCAR
pa icipan s only when exchanging sa e y in o ma ion abou
ele an measu es and/o ecommenda ions ela ing wi h
he p e en ion o ad e se inciden s conce ning medical de-
ices. This o m is designed o exchanging in o ma ion be-
ween NCAR pa icipan s; i should no be passed di ec ly
inadequados ou insegu os do me cado.
Pala as-cha e: Equipamen os e Sup imen os; Segu ança do Doen e/legislação & ju isp udência
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on o pa ien s, use s, hi d pe sons o he public.”. Among
he examples o inciden s and ield sa e y co ec i e ac ions
which he manu ac u e should epo a e “pa ien dies a e
he use o a de ib illa o and he e is an indica ion o a p ob-
lem wi h he de ib illa o ”, “loss o sensing a e a pacemake
has eached end o li e; elec i e eplacemen indica o did
no show up in due ime, al hough i should ha e acco ding
o de ice speci ica ion” o “an in usion pump s ops, due o
a mal unc ion o he pump, bu ails o gi e an app op ia e
ala m; he e is no pa ien inju y”, i.e. se e e (o po en ially
se e e) inciden s wi h MDs.14 In 2017, Ge many (popula-
ion = 82 521 653 inhabi an s), Uni ed Kingdom (popula-
ion = 65 884 142 inhabi an s), and F ance (popula ion =
66 809 816 inhabi an s) had he highes p e alence o such
se ious inciden s (981 (100%) NCARS exchanged be ween
17 Coun ies): 363 NCARs (37.0%), 190 NCARs (19.3%),
and 115 NCARs (11.7%), espec i ely, while only 3 NCARs
(0.3%) such inciden s we e speci ically epo ed in Po ugal
(popula ion = 10 309 573 inhabi an s). As o coun ies wi h
a simila popula ion size o Po ugal, 2017 da a (981 (100%)
NCARs exchanged be ween 17 coun ies), he numbe o
NCARs and inhabi an s: Czech Republic 4 NCARs (0.4%)
(popula ion = 10 578 820 inhabi an s), Aus ia ou NCARs
(0.4%) (popula ion = 8 772 865 inhabi an s), Belgium 40
NCARs (4.1%) (popula ion = 11 351 727 inhabi an s) and
Sweden 44 (4.1%) NCARs (4.5%) (popula ion = 9 995 153
inhabi an s).7,12,15
Besides egis e ing inciden s wi h MDs, na ional medi-
cines agencies (one in each EU coun y) a e esponsible
o o he unc ions, namely designa ion o MDs, inspec ion
o manu ac u e s o MDs, including he collec ion o MDs
samples, p oceedings o in ingemen (e.g. applica ion o
ines) o implemen ing and moni o ing he implemen a ion
o na ional and in e na ional egula ions on MDs, including
he publica ion o MD sa e y ale s.1 These a e di ec ed o
heal hca e p o essionals and pa ien s.16
Gi en ha MDs may be associa ed wi h se e e o po-
en ial se e e inciden s/e en s and pa ien s may unde -
use sa e y in o ma ion on MDs,7, 12-14 he aims o his s udy
we e: (i) o iden i y and ca ego ize all ale s on MDs issued
by he Po uguese Medicines Agency, INFARMED, I.P. du -
ing 2017 and published in i s o icial websi e, (ii) o compa e
he occu ence o Po uguese sa e y ale s wi h he a es in
o he EU coun ies and, (iii) o discuss measu es o mi iga e
he isks associa ed wi h sa e y conce ns on MDs, i.e., o
discuss possible new egula o y sa e y ecommenda ions,
which may be globally accep ed, knowing medicines agen-
cies and heal h au ho i ies ha e a collabo a i e amewo k
owa ds public heal h sa e y.
MATERIAL AND METHODS
Desc ip i e s udy: sa e y ale s on MDs we e collec ed
h ough he web add ess o he Po uguese medicines
agency (INFARMED, I.P.): h p://www.INFARMED.p /web/
INFARMED/ale as/disposi i os-medicos du ing Janua y
2018. These ale s also co e inciden s wi h MDs ma ke ed
in he emaining EU coun ies. Thus, i is possible o ob ain
an indi ec indica o o all signi ican inciden s wi h MDs in
he EU.
Inclusion and exclusion c i e ia
All Po uguese na ional sa e y ale s on MDs published
by INFARMED, I.P. on he o icial websi e in 2017 (inclusion
c i e ia) we e analyzed because i was he mos ecen ly
a ailable in o ma ion when he p esen s udy was ca ied
ou . Exclusion c i e ia: publica ions desc ibing o he ypes
o sa e y issues.
Po uguese sa e y ale s on MDs
S udy da a we e ex ac ed and p ocessed as ollows:
(i) i s ly, sa e y ale s we e iden i ied i.e. all sa e y ale s
on MDs published in he o icial si e o INFARMED, I.P. be-
ween Janua y 1s 2017 and Decembe 31s 2017, (ii) sec-
ondly, hey we e egis e ed i.e. all online a ailable in o ma-
ion was collec ed in a wo d documen and he o iginal in o -
ma ion was a chi ed in digi al o ma ; and (iii) hi dly, hese
sa e y ale s we e analyzed as ollows: ype o equi ed ac-
ion aken by he na ional compe en au ho i y (NCA) (de-
ices ha a e olun a ily wi hd awn om he ma ke e sus
‘o he si ua ions’) o iden i ica ion o MDs ma ke ed in Po -
ugal e sus MDs no ma ke ed in Po ugal. In he g oup o
de ices olun a ily wi hd awn om he ma ke , coun e ei
o alsi ied de ices we e also quan i ied. The ‘o he si ua-
ions’ we e based on quali a i e classi ica ions a ibu ed by
he esea che s a e eading he ull con en o each iden i-
ied sa e y ale (please see ‘Po uguese sa e y ale s on
MDs’ in he sec ion o esul s). The p esen analysis was
double-checked by wo esea che s.
S udy a iables we e con enien ly selec ed based on
he publicly a ailable in o ma ion in he sa e y ale (pub-
lished ale ). O he a iables we e no a ailable in hese
published sa e y ale s (e.g. he se e i y o a possible inci-
den , class o de ice, possible yea o comme cializa ion in
Po ugal, he exis ence o Field Sa e y Ac ions).
Ac ions aken by he egula o y au ho i y
The ac ions aken by INFARMED, I.P. a e p esen ed in
Table 1.
Es ima ed p opo ions o NCARs pe million o inhabi -
an s
A sub-analysis abou NCARs was ca ied ou because
i seems hese epo s a e ela ed wi h se e e o po en ially
se e e sa e y e en s.7,12-14 Besides Po ugal, he selec ed
coun ies o his compa ison we e Ge many, Uni ed King-
dom and F ance because hey a e conside ed leading Eu-
opean economies wi h a much la ge popula ion and MDs
ma ke han Po ugal, hus po en ially app op ia e o de ec
eme ging sa e y issues. Mo eo e , he Czech Republic,
Aus ia, Belgium and Sweden we e e alua ed, since hey
p esen a simila popula ion size o Po ugal.15,17
Acco ding o he o icial epo s, he numbe o NCARs
sen by each coun y we e Po ugal (n = 3), Czechia (n
= 4), Aus ia (n = 7), Belgium (n = 40), Sweden (n = 44),
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Re is a C ie n í ic a d a O de m do s M édi co s ww w.ac am ed ic a po u gu es a.c om
Ge many (n = 363), Uni ed Kingdom (n = 190), and F ance
(n = 115).12
The numbe o NCARs pe million inhabi an s in each o
he e alua ed coun ies was calcula ed conside ing: (i) he
da a o Eu opean 2011 census and he demog aphic da a o
Eu os a (2017 da a) and (ii) he da a o 2017 NCAR; please
see he public epo s he e: h ps://ec.eu opa.eu/heal h/
md_sec o /ma ke -su eillance-and- igilance_en.12,15,17
RESULTS
Po uguese sa e y ale s on MDs
A o al o 32 (100%) sa e y ale s on MDs we e iden i ied
in he o icial websi e o INFARMED, I.P.. O e all, 18 ou o
32 (56%) de ices wi hou eco ds o comme cializa ion a
a na ional le el; eigh ou o 32 (25%) o he si ua ions and
six ou o 32 (19%) de ices olun a ily wi hd awn om he
ma ke (Table 1).
Ac ions aken by he egula o y au ho i y
The main ac ions aken by INFARMED, I.P. a e p esen -
ed in Table 1.
Rega ding, he de ices wi hou eco ds o comme ciali-
za ion a a na ional le el (18 in 32), INFARMED, I.P. has
ecommended no o pu chase o use he MD. These ale s
we e dissemina ed by NCAs om he Uni ed Kingdom, Ge -
many, Denma k, and Poland. Pa icula ly, one ale om he
18 ale s wi hou eco ds o comme cializa ion a na ional
le el was abou in i o diagnos ic medical de ices: a CE
ma king was no a ixed in eagen s o in i o diagnos ics
( hese eagen s we e wi hd awn om he ma ke by he
Ge man au ho i ies). Due he ee mo emen o goods in
he Eu opean Union, INFARMED, I.P. has speci ically ec-
ommended ha hese eagen s should no be pu chased o
used since, he e is no e idence o hei sa e y, quali y o
pe o mance.
The ‘o he si ua ions’ (eigh ale s) conce ned limi a ions
on he unc ioning o he MDs (e.g., so wa e o ins uc ion
upda es o o e come unc ion issues, such as he limi ed
capaci y o a ba e y; suspension o comme cializa ion and
e u n o all de ices o he manu ac u e ; o new ins uc ions
due o a quali y issue). The cases o coun e ei o alsi ied
de ices a e included in he g oup o ale s om de ices ol-
un a ily wi hd awn om he ma ke (six ale s).
Es ima ed p opo ions o NCARs pe million o inhabi -
an s
O e all, a leas h ee ou o 32 MDs sa e y ale s we e
ela ed o se ious inciden s, which is in line wi h he h ee
NCARs no i ied in Po ugal du ing 2017.12 A a e o 0.28
NCARS (i.e. epo s o ele an inciden s, such as se e e
o po en ially se e e inciden s) pe million inhabi an s in
Po ugal was calcula ed using 2011 census da a and/o o
0.29 NCARs pe million inhabi an s using 2017 Eu os a
da a.12,15,17 The EU coun ies wi h he highes p opo ion
o NCARs we e: Ge many wi h 4.53 NCARs pe million in-
habi an s, UK wi h 3.0 NCARs pe million inhabi an s, and
F ance wi h 1.77 NCARs pe million inhabi an s. Rega ding
he coun ies wi h a simila numbe o inhabi an s (popula-
ion size) o Po ugal: Czech Republic wi h 0.38 NCARs pe
million inhabi an s; Aus ia wi h 0.46 NCARs pe million in-
habi an s; Belgium wi h 3.52 NCARs pe million inhabi an s
and Sweden wi h 4.40 NCARs pe million inhabi an s.7,12,15
The Ge man, F ench, UK and Po uguese ma ke s ac-
coun ed o 26; 14.5; 9.8 and 1.2 billion eu os in sales o
MDs, espec i ely (2015 da a).18,19 Rega ding expo s and
impo s espec i ely o MDs (2017 da a), he s udied coun-
ies accoun ed o : Ge man (25 811 and 16 676 million o
eu os), F ance (6984 and 9785 million o eu os), Uni ed
Kingdom (5513 and 7334 million o eu os), Czechia (1053
and 974 million o eu os), Aus ia (1909 and 1930 million
o eu os), Belgium (12 071 and 9689 million o eu os) and
Sweden (1441 and 1595 million o eu os).20
DISCUSSION
O e all, he numbe o public ale s on MDs in he o -
icial websi e o INFARMED, I.P. (32 sa e y ale s in 2017)
is clea ly below he o al numbe o no i ica ions o inciden s
and sa e y co ec i e ac ions conce ning MDs in Po u-
gal (n = 1645 ou o 244 138 egis e ed MDs in 2017).13 In
his sense, i is likely ha INFARMED, I.P. has speci ically
published hese ale s based on sa e y and po en ial isk
c i e ia. Fo ins ance, he medicines agencies o he USA
and Aus alia [Food and D ug Adminis a ion (FDA) and he
The apeu ics Goods Adminis a ion (TGA), espec i ely]
ha e also only published 11 and a ound 20 sa e y commu-
nica ions abou MDs, espec i ely (2017 publica ions),21,22
which seems o be aligned wi h he numbe o sa e y ale s
on MDs published by INFARMED, I.P.. I seems MDs in-
dus y is sa ely ope a ing, conside ing he limi ed numbe o
Pi es C, e al. Medical de ice ale s in Po ugal, Ac a Med Po 2021 Ma ;34(3):201-208
Table 1 – Ac ions aken by he Po uguese na ional medicines agency a e a sa e y ale on MDs (n = 32; 100% sa e y ale s)*
Type o ac ion Desc ip ion
Recommenda ions n1 = 26 (81.2%) - con ac ing he e ail selle o ecei e a new sa e y ale 6.3% (2 in 32)
- con ac ing he dis ibu o s o ecei e a so wa e upda e 9.3% (3 in 32)
- ecommenda ions o no pu chase o use a ce ain MD, conce ning MDs wi hou eco ds o
comme cializa ion in Po ugal 56.3% (18 in 32)
- using he MD acco ding o he ins uc ions 9.3% (3 in 32)
Manda o y Decisions n2 = 6 (1.8%) - immedia ely suspend comme cializa ion and e u n all de ices o he manu ac u e and no
acqui e o use he MD 18.8% (6 in 32)
To al (n1 + n2) 32 (100%)
* The same MD can issue di e en sa e y ale s simul aneously
ARTIGO ORIGINAL
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205
sa e y ale s published on he websi es o medicines agen-
cies, such as INFARMED, I.P., FDA and TGA.21,22 Howe e ,
mo e s udies on he p esen opic a e ecommended. On
he o he hand, 981 NCARS we e exchanged be ween 17
EU Coun ies du ing 2017,12 al hough hese NCARs may be
abou he same ype o MDs.
Po uguese sa e y ale s on MDs and ac ions aken by
he egula o y au ho i y
Conce ning he 32 sa e y ale s iden i ied in he o icial
websi e o INFARMED, I.P., mo e han hal o hese ale s
we e ela ed wi h de ices wi hou iden i ied eco ds o com-
me cializa ion a a na ional le el. This can be conside ed
e y encou aging ega ding he dissemina ion o sa e y in-
o ma ion, since people and p oduc s can ci cula e wi hin
he EU and ci izens li ing in Po ugal may be using an MD
no ma ke ed in his e i o y. Al e na i ely, i may be an indi-
ca o o lowe usage o MDs wi hin he Po uguese popula-
ion due o a mo e limi ed budge (i.e. economic es ic ions),
en o cemen o na ow c i e ia o selec /buy MDs a hospi al
le el o di e en popula ion heal h needs. In e es ingly, only
one ale abou an in i o MDs no ma ke ed in Po ugal
was de ec ed. This may e lec he lowe p opo ion o in
i o MDs in ela ion o he global numbe o ma ke ed MDs.
Fo ins ance, he o al heal hca e expendi u e in Eu ope is
as ollows: 76.9% inpa ien & ou pa ien ca e, o he ; 15.9%
pha maceu icals & o he medical non-du ables and 7.2%
medical echnology (6.5% medical de ices, including imag-
ing and 0.7% in i o diagnos ics) (2017 da a).20
The ypes o ac ions aken by he na ional medicines
agency ( ecommenda ions o manda o y decisions) we e
dependen on he se e i y o he ale . This was he case o
he six manda o y decisions ela ed wi h quali y issues, e.g.,
coun e ei de ices ecei ing ma ke suspension and ecall
o de aul MDs, which we e in ol ed in he h ee inciden s.
Rele an in o ma ion is lacking on he ale s o s udied MDs,
such as he se e i y o a possible inciden , class o a de ice,
possible yea o comme cializa ion, he exis ence o ield
sa e y ac ions, e c. These could be ela ed wi h con iden ial-
i y issues and/o he in o ma ion o ma . Na ional medicines
agencies a e legally equi ed o p esen his in o ma ion in
a s uc u ed way (NCAR), and some egula o y in o ma-
ion should emain con iden ial (see Annex VII o MEDDEV
2.12/1 e .8).14
Aside om he ale s on he EU websi es, na ional medi-
cines agencies and he compulso y MDs inciden epo ing
sys em (Eudamed),12 compu e -based sys ems in eg a ed
in o MDs o in apps o pa ien s may con ibu e o inc ease
he sa e use o MDs. Fo ins ance, elec onic means (e.g.,
au oma ed emails), o so wa e pla o ms, which a e based
on indi idual da a and sui able algo i hms and a e p o-
g ammed o simula e he use o MDs. O he applica ions
a e cu en ly unde de elopmen o assis he selec ion o
he sa es de ice o a ce ain pa ien .23,24
Ac ions o inc ease he awa eness o heal hca e p o es-
sionals and pa ien s a e also needed. Mo eo e , di e ences
in he p opo ions o no i ied sa e y ale s be ween coun ies
could be jus i iable by a po en ial unde epo ing o cases,
al hough he e is no da a o con i m his assump ion. Use s
o MDs should be mo i a ed o p o ide ac i e eedback on
how o imp o e MDs and how o an icipa e possible inci-
den s. E en hough end-use s a e heo e ically unable o
acqui e MDs (a leas om he high- isk ca ego ies), since
hese MDs a e acqui ed/pu chased by hospi als, pa ien s
should emain in o med on he con en o MDs ale s, es-
pecially i consume s ca y one MDs inside he body (o
di ec ly con ac ing wi h he body). Only MDs coded by IN-
FARMED, I.P. and included in he espec i e da abase may
be pu chased by he Na ional Heal h Se ice (SNS) in Po -
ugal.25 In his sense, a unique ID code o each MD in he
EU ma ke would be an impo an s ep o ensu e aceabili y
and o es ablish causali y in bo h posi i e and nega i e pa-
ien ou comes.26
Es ima ed p opo ions o NCARs pe million o inhabi -
an s
The es ima ed p opo ion o NCARs pe million inhabi -
an s in Po ugal is below he alues egis e ed by he o he
e alua ed EU coun e pa s, including he analyzed coun-
ies wi h simila popula ion sizes o Po ugal (i.e. Czech
Republic, Aus ia, Belgium and Sweden).12 This si ua ion
may be explained by he ac ha Po ugal and he Czech
Republic a e among he coun ies wi h he lowes numbe
o sales o MDs, hus being mo e likely o p esen a small
numbe o NCARs pe million inhabi an s.15,18-20 Addi ion-
ally, his seems o be a low p opo ion o epo s looking a
he Ge man ma ke , which is app oxima ely 23 imes mo e
aluable han he Po uguese one; howe e , Ge many eg-
is e ed a a e o MD sa e y ale s only 16 imes highe han
Po ugal.18-20 Finally, a leas some MDs sa e y p oblems
may no ha e been no i ied by use s/pa ien s o heal hca e
p o essionals (i.e., unde epo ing o sa e y p oblems o
MDs) and he numbe o inspec ions o iden i y alsi ied o
unsa e MDs may be limi ed in ou coun y. In his sense, ig-
ilance and inspec ions sys em on he sa e y o MDs should
be s eng hened by he na ional medicines agency, since
moni o ing sa e y o MD is pa amoun .
New EU egula ion on MDs
Recen EU legisla ion on medical de ices has come
in o o ce ecen ly: he Regula ion 2017/745 o he Eu o-
pean Pa liamen and o he Council o 5 h Ap il 2017 (no ye
ansposed).9 The da a and/o analysis in he p esen s udy
ha e no eme ged om he applica ion o his new egula-
ion, conside ing his egula ion will only be ansposed o
applied by each o he Eu opean coun ies in he nex ew
yea s ( ansi ion pe iod). Impo an ly, i seems ha he old
concep s and de ini ions a e conside ed in his new egula-
ion; howe e , Regula ion 2017/745 is b oade , and among
o he s, i includes mo e designa ions ega ding medical
de ices and/o medical pu poses. Fo ins ance, implan s
and eagen s ha e been speci ically conside ed MDs, as
well as, addi ional medical pu poses ha e been speci i-
cally conside ed such as moni o ing an inju y o disabili y;
Pi es C, e al. Medical de ice ale s in Po ugal, Ac a Med Po 2021 Ma ;34(3):201-208

ARTIGO ORIGINAL
206
Re is a C ie n í ic a d a O de m do s M édi co s ww w.ac am ed ic a po u gu es a.c om
Pi es C, e al. Medical de ice ale s in Po ugal, Ac a Med Po 2021 Ma ;34(3):201-208
in es iga ion, eplacemen o modi ica ion o he ana omy
o a pa hological p ocess o s a e; o “p o iding in o ma ion
by means o in i o examina ion o specimens de i ed om
he human body, including o gan, blood and issue dona-
ions, and which does no achie e i s main in ended ac ion
by pha macological, immunological o me abolic means, in
o on he human body, bu which may be assis ed in i s
unc ion by such means”.8 Thus, as expec ed, he isk clas-
si ica ion was also upda ed, al hough MDs a e s ill classi-
ied in he same numbe o classes: I e.g., non-in asi e de-
ices no included in he o he classes such as non-in asi e
de ices in ended o be used as a mechanical ba ie , o
comp ession o o abso p ion o exuda es; IIa e.g., non-
in asi e de ices in ended o channelling o s o ing blood,
body luids, cells o issues, liquids o gases o he pu pose
o e en ual in usion, adminis a ion o in oduc ion in o he
body o in asi e de ices in ended o sho - e m use – and
no included in ano he class; IIb e.g., non-in asi e de ices
in ended o modi ying he biological o chemical compo-
si ion o human issues o cells, blood, o he body liquids
o o he liquids in ended o implan a ion o adminis a ion
in o he body o in asi e de ices in ended o long- e m
use – and no included in o he class; and III e.g., su gically
in asi e de ices in ended speci ically o con ol, diagnose,
moni o o co ec a de ec o he hea o he cen al ci -
cula o y sys em h ough di ec con ac wi h hose pa s o
he body, o o al o pa ial join eplacemen s. I seems
like class I MDs emain, espec i ely, classi ied as low- isk
de ices, IIa and IIb medium- isk de ices and class III high-
isk de ices in acco dance wi h a icle 51 and Annex VIII o
Regula ion 2017/745. Ano he ele an poin in his docu-
men is he p e ision o a speci ic pos -ma ke su eillance
sys em on MDs (Chap e VII), which s a es ha , “ o each
de ice, manu ac u e s shall plan, es ablish, documen , im-
plemen , main ain and upda e a pos -ma ke su eillance
sys em in a manne ha is p opo iona e o he isk class
and app op ia e o he ype o de ice” (a icle 83).9
Among he possible consequences o he applica ion
o Regula ion 2017/745 a e a highe numbe o egis e ed
MDs and sa e y ale s on MDs in he EU, since he scope o
applica ion o he new Regula ion is b oade . On he o he
hand, i is likely ha he use o MDs in he EU will end o be-
come sa e because mo e ypes o MDs and i s espec i e
applica ions a e co e ed by his new egula ion and manu-
ac u e s a e equi ed o de ine a pos -ma ke su eillance
sys em in acco dance wi h Chap e VII. 9
Addi ional egula o y ecommenda ions on MDs
The de elopmen o da abases comp ising pa ien da a
om MDs use is ecommended because i may ensu e he
gene a ion o au oma ic ale s, e.g., email and/o phone
wa nings. O he ypes o web-based applica ions may be
de eloped o ensu e sa e use o MDs in pa ien s. Among
o he s, new applica ions may be dissemina ed in he web-
si es o egula o y agencies, which a e commonly used o
dissemina e igilance in o ma ion. Social ne wo ks may be
used o dissemina e in o ma ion on sa e y o e icacy ale s
o MDs, al hough mo e s udies on he use o social ne -
wo ks as a way o dissemina ing sa e y in o ma ion on MDs
a e equi ed. Na ional medicines agencies may ecommend
ha na ional medicines agencies suppo /s eng hen he
publica ion o mo e dedica ed in o ma ion abou he sa e y
ale s o MDs in ended o pa ien s and consume s, since
he analyzed sa e y ale s and EU s a is ics only p o ide
limi ed in o ma ion. Fo ins ance, i was no possible o ind
speci ic in o ma ion abou he se e i y o inciden s, possible
causes, class o de ice, e c. This in o ma ion is pa icula ly
ele an o heal hca e p o essionals, and he gene al pub-
lic in o de o inc ease pa ien sa e y.27
As a as he egula o y ecommenda ions on MDs he e
p oposed a e conce ned, he scope o in e en ion o he
na ional medicines agencies may need o be ex ended and
ampli ied, o ins ance wi h he en o cemen o egula ion
2017/745.9 Mo eo e , p i a e o semi-public o ganiza ions
may be c ea ed in o de o supe ise he in e en ion o
medicines agencies, NB and/o manu ac u e s, namely wi h
compulso y en ollmen o pa ien s and p o ide s.
S udy limi a ions
The MDs om he sa e y ale s we e no checked agains
he Po uguese Code o he Medical De ice (CMD) and i s
espec i e Po uguese Nomencla u e o Medical De ices
(NPDM),28 because ei he CMDs o NPDMs we e no made
a ailable in he sa e y ale s published by INFARMED, I.P..
Howe e , b ands and/o p oduce names o MDs we e
p esen ed in he published sa e y ale s, and almos all o
hese b ands and/o p oduce s we e no mo e a ailable in
he CMD Po uguese da abase (h ps://www.in a med.p /
web/in a med/pesquisa-disposi i os)28 (e.g. PRIMEDIC
De iMoni o XD®, A asningsse EPI-SPINAL Pack®, Fenix
Face Resu acing Sys em® o Thomas Moni o Sys ems).
Simila ly, he exis ence o a possible combina ion o de-
ices and he Classes o he MDs o he sa e y ale s we e
no speci ically in es iga ed, which was due o he limi ed
in o ma ion on he published ale s. The websi es o o he
compe en medicines agencies (Eu opean o non-Eu ope-
an) we e no checked ega ding he sa e y ale s on MDs,
al hough compa a i e analyses on ele an inciden s based
on NCARS epo s we e no ca ied ou .12 Finally, speci ic
compa isons (e.g., be ween di e en MD classes o di e -
en se e i ies o e en s) o sa e y ollow-ups we e no spe-
ci ically ca ied ou .
CONCLUSION
The Po uguese Medicines Agency con ibu es o he
ci izens’ access o quali y medical de ices, by issuing sa e-
y ale s, ecommenda ions and manda o y ma ke wi h-
d awals o unsui able o unsa e MDs. Despi e he limi ed
numbe o sa e y ale s in Po ugal, cases o coun e ei o
alsi ied MDs ha e been iden i ied. These si ua ions we e
ollowed by co ec i e ac ions o ensu e public heal h. The
low numbe o sa e y ale s in Po ugal, compa ed o o he
EU coun ies may be explained by he ollowing po en ial
easons: (i) some MDs sa e y p oblems may ha e no been
ARTIGO ORIGINAL
R e i s a C i e n í i c a d a O d e m d o s M é d i c o s w w w.a c a m e d i c a p o u g u e s a . c o m
207
no i ied by use s/pa ien s o heal hca e p o essionals (i.e.,
unde epo ing o sa e y p oblems wi h MDs), (ii) limi ed
numbe o MDs ma ke ed in Po ugal p obably due o eco-
nomic es ic ions, (iii) he numbe o inspec ions o iden i y
alsi ied o unsa e MDs may be limi ed o (i ) MDs in he na-
ional ma ke may be less p one o sa e y p oblems, since
no all MDs ma ke ed in he EU a e a ailable in Po ugal.
Among o he s, ein o cing igilance and inspec ion sys-
ems ega ding he sa e y o MDs is ecommended and
new egula o y sa e y ecommenda ions may comp ise he
compulso y deli e y o elec onic ale s, such as emails o
ensu e he ecep ion o sa e y in o ma ion by all pa ien s.
Mo eo e , he de elopmen o apps o o he applica ions o
assis pa ien use, including op imiza ion o MDs in eal- ime
o he exis ence o a unique ID code in he EU o ensu e he
aceabili y o MDs. Fu he s udies a e equi ed o con i m
hese p elimina y esul s.
DISCLOSURE
A chap e on a simila opic was published in: Pi es C,
Dua e D. A egula o y and sa e y pe spec i e on medical
de ices. In: Mehdi Khos ow-Pou DB, edi o . Encyclopedia
o In o ma ion Science and Technology - Chap e 125. 5 h
ed. IGI Global; 2021:1815-26. doi: doi:10.4018/978-1-7998-
3479-3.ch125.
PROTECTION OF HUMANS AND ANIMALS
The au ho s decla e ha he p ocedu es we e ollowed
acco ding o he egula ions es ablished by he Clinical Re-
sea ch and E hics Commi ee and o he 2013 Helsinki Dec-
la a ion o he Wo ld Medical Associa ion.
DATA CONFIDENTIALITY
The au ho s decla e ha ing ollowed he p o ocols in
use a hei wo king cen e ega ding pa ien s’ da a publica-
ion.
CONFLICTS OF INTEREST
The au ho s epo no con lic s o in e es .
FUNDING SOURCES
Fundação pa a a Ciência e a Tecnologia (FCT) p ojec
UID/DTP/04567/2016.
Pi es C, e al. Medical de ice ale s in Po ugal, Ac a Med Po 2021 Ma ;34(3):201-208
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