natgillin/translations-raw huggingface dataset:
As Directive 93/42/EEC essentially provides that medical devices may be placed on the market and/or put into service only if they meet the requirements of the Directive (Article 2) and that the Member States must not create any obstacle to the placing on the market and/or the putting into service of devices which, in order to prove compliance with the requirements, have been the subject of an assessment of their conformity in accordance with the Directive (Article 4) and as Article 8 of the Directive requires the Member State concerned, where there is a risk to health or safety, to take measures ‘to withdraw such devices from the market or prohibit or restrict their being placed on the market or put into service’ and requires the Commission to verify whether such measures are justified, this Commission Decision relates to the measure taken by the French authorities to restrict the presence on the market of the device in question.
Budući da se Direktivom 93/42/EEZ predviđa da se medicinski proizvodi mogu staviti u promet i/ili u uporabu samo ako poštuju zahtjeve Direktive (članak 2.) i da države članice ne smiju stvarati nikakve prepreke stavljanju u promet ili stavljanju u uporabu proizvoda čija je sukladnost ocijenjena u skladu s Direktivom kako bi se dokazalo da poštuju zahtjeve (članak 4.) i s obzirom na to da se člankom 8. Direktive predmetnoj državi članici nalaže da, ako postoji rizik za zdravlje ili sigurnost, poduzme mjere da „povuče takve proizvode iz prometa ili zabrani ili ograniči njihovo stavljanje u promet ili stavljanje u uporabu” te Komisiji nalaže da ispita opravdanost tih mjera, ova Odluka Komisije odnosi se na mjeru francuskih tijela kojom se ograničava prisutnost predmetnog proizvoda na tržištu.
It is clear from the decision notified by the French authorities and from the consultations conducted with the interested parties that compliance with the essential requirements of the Directive concerning the risk/benefit ratio and minimising risk and the proper application of standards are being called into question.
Iz odluke koju su dostavila francuska tijela i savjetovanja sa zainteresiranim stranama proizlazi da se dovodi u pitanje poštovanje bitnih zahtjeva Direktive koji se odnose na omjer koristi i rizika i svođenje rizika na najmanju moguću mjeru te na ispravnu primjenu normi.
Failure to comply with essential requirements
Nepoštovanje bitnih zahtjeva
Essential requirements concerning the risk/benefit ratio
Bitni zahtjevi koji se odnose na omjer koristi i rizika
Section 1 of Annex I to Directive 93/42/EEC provides: ‘The devices must be designed and manufactured in such a way that, when used under the conditions and for the purposes intended, they will not compromise the clinical condition or the safety of patients, or the safety and health of users or, where applicable, other persons, provided that any risks which may be associated with their use constitute acceptable risks when weighed against the benefits to the patient and are compatible with a high level of protection of health and safety […]’.
U točki 1. Priloga I. Direktivi 93/42/EEZ utvrđeno je sljedeće: „Proizvodi moraju biti projektirani i proizvedeni tako da, korišteni u predviđenim uvjetima i za predviđenu namjenu, ne ugrožavaju kliničko stanje ni sigurnost pacijenata, ni sigurnost ni zdravlje korisnika ni, gdje je primjenjivo, drugih osoba, uz uvjet da svi rizici koji se eventualno povezuju s njihovom uporabom tvore prihvatljive rizike u usporedbi s korišću za pacijenta i uključuju visoku razinu zaštite zdravlja i sigurnosti […]”.
Section 6 of Annex I to the Directive provides: ‘Any undesirable side-effect must constitute an acceptable risk when weighed against the performances intended’.
U točki 6. Priloga I. toj direktivi utvrđeno je sljedeće: „Svaki štetni događaj mora predstavljati prihvatljivi rizik u usporedbi s namijenjenim učincima.”
As regards the risks, it should be pointed out at the outset that the risk caused by the ingestion of lead is widely documented, in particular in the publications cited by the ‘Guideline for elemental impurities – Q3D’ drawn up by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), in the ‘Report on Carcinogens, fourteenth edition’ of the U.S. Department of Health and Human Services, in the ‘Scientific opinion on lead in food’ of the European Food Safety Authority (EFSA) and in the publications cited by Commission Regulation (EC) No 1881/2006.
Kada je riječ o riziku, treba prije svega reći da je rizik od unosa olova u velikoj mjeri dokumentiran, posebno u publikacijama navedenima u „Smjernicama o elementarnim nečistoćama – Q3D”, koje je sastavilo Međunarodno vijeće za usklađivanje tehničkih zahtjeva za lijekove za ljudsku uporabu (ICH), u „Izvješću o karcinogenim tvarima, četrnaesto izdanje” američkog Ministarstva zdravstva i socijalne skrbi, u „Znanstvenom mišljenju o olovu u hrani” Europske agencije za sigurnost hrane (EFSA) i u publikacijama iz Uredbe Komisije (EZ) br. 1881/2006.
In the present case, the device contains lead and is intended to be ingested.
U ovom slučaju proizvod sadržava olovo i namijenjen je prehrani ljudi.
It should also be noted that the public is exposed to lead by many routes (air, water, food), with the result that any additional exposure, such as that caused by use of the device, increases the risk associated with exposure to lead.
Nadalje, treba napomenuti da je stanovništvo izloženo olovu na mnogo načina (preko zraka, vode, hrane) te se svakim dodatnim izlaganjem, kao onim nastalim zbog uporabe predmetnog proizvoda, povećava rizik povezan s izloženošću olovu.
It establishes a permitted daily exposure for elements of toxicological concern.
U Smjernicama je određena dopuštena dnevna izloženost za elemente koji uzrokuju zabrinutost u pogledu toksičnosti.
For lead, the Guideline indicates that exposure to this element may cause neurological, reproductive, immune, cardiovascular and renal health effects; it establishes permitted daily exposure at 5 μg per day, irrespective of the route of administration.
Za olovo je navedeno da izloženost tom elementu može utjecati na neurološki, reproduktivni, imunološki i kardiovaskularni sustav te na bubrege; dopuštena dnevna izloženost određena je na 5 μg dnevno, neovisno o putu primjene.
The tests to which the French authorities refer show that the device contains levels of lead between 16 and 22,9 μg/g.
Prema analizama na koje se pozivaju francuska tijela udio olova u proizvodu iznosi od 16 do 22,9 μg/g.
A course of treatment involving six capsules of 335 mg per day (i.e. 2 g per day), as provided for in the instructions for use of the device, corresponds to an ingested amount of lead of between 32 and 46 μg per day, which is several times higher than the reference threshold of 5 μg per day.
Doza od šest kapsula od 335 mg dnevno (što znači 2 g dnevno), kako je navedeno u uputama za uporabu proizvoda, odgovara količini od 32 do 46 μg konzumiranog olova dnevno, čime se višestruko premašuje referentna granična vrijednost od 5 μg dnevno.
With regard to use of Guideline ICH Q3D, it should be pointed out that this Guideline, while it applies formally to medicinal products, concerns the presence of elements (including lead) which do not provide any therapeutic benefit (elemental impurities) and which raise toxicological concerns in products administered orally, amongst other routes.
U pogledu primjene Smjernica ICH Q3D treba istaknuti da se one, iako se službeno primjenjuju na lijekove, odnose na prisutnost elemenata (uključujući olovo) koji ne pridonose liječenju (elementarne nečistoće) i koji uzrokuju zabrinutost u pogledu toksičnosti proizvoda koji se unose, među ostalim, oralnim putem.
It may therefore be considered relevant in assessing the risk associated with using a medical device which contains lead as an impurity and which is administered orally.
Stoga se mogu smatrati relevantnima za procjenu rizika povezanog s uporabom medicinskog proizvoda koji sadržava olovo kao nečistoću i koji se unosi oralnim putem.
Finally, it should be pointed out that the manufacturer does not contest the fact that the device contains lead.
Naposljetku, treba napomenuti da proizvođač ne osporava prisutnost olova u proizvodu.
Nor does the manufacturer contest the fact that lead is released by the device, albeit to a minor extent.
Štoviše, proizvođač ne osporava činjenicu da proizvod ispušta olovo, iako smatra da je to ispuštanje na vrlo niskoj razini.
Moreover, the manufacturer indicates that the risks identified by the reports cited by the French authorities — namely cardiovascular, neurological and nephrotoxic effects of lead in humans — were taken into account through the indications in the instructions for use of the device, in such a way that the essential requirement of Section 1 of Annex I to the Directive has been met; the manufacturer therefore acknowledges that use of the device poses risks, albeit at an acceptable level.
Osim toga, proizvođač navodi da su rizici utvrđeni u izvješćima na koja upućuju francuska tijela – odnosno kardiovaskularni, neurološki i nefrotoksični učinci olova kod ljudi – uzeti u obzir u napomenama u uputama za uporabu proizvoda te je time osigurano poštovanje bitnih zahtjeva iz točke 1. Priloga I. Direktivi; on time priznaje da uporaba proizvoda predstavlja rizik, no smatra da je razina rizika prihvatljiva.
In addition, a report from the NAMSA laboratory cited by the manufacturer acknowledges that there is a risk associated with the presence of lead in the device, while describing this risk as low.
Štoviše, u izvješću laboratorija NAMSA koje navodi proizvođač potvrđuje se da postoji rizik zbog prisutnosti olova u proizvodu, no smatra se niskim.
It follows from the above that use of the device poses a risk to the health or safety of patients which the manufacturer is responsible for keeping within acceptable limits in relation to the benefits provided by the device.
Iz navedenog slijedi da uporaba proizvoda uključuje rizik za zdravlje ili sigurnost pacijenata koji proizvođač mora zadržati unutar prihvatljivih granica s obzirom na koristi proizvoda.
As regards the benefits, according to the instructions for use, the device is intended to ‘prevent digestive problems, reduce digestive discomfort, restore digestive comfort and reduce abdominal circumference’.
Kada je riječ o koristima, prema uputama za uporabu proizvod je namijenjen „sprečavanju i smanjenju probavnih smetnji, olakšavanju probave i smanjenju opsega struka”.
It should be pointed out that, in accordance with Article 1(2) of the Directive, a medical device is assumed to have a medical purpose.
Valja podsjetiti da u skladu s člankom 1. stavkom 2. Direktive medicinski proizvod podrazumijeva medicinsku namjenu.
In the present case, it would seem that among the four claims made in the instructions for use, only the one relating to ‘preventing digestive problems’ could possibly be described as being medical in nature.
U ovom slučaju čini se da se od četiri namjene navedene u uputama samo ona koja se odnosi na „sprečavanje probavnih smetnji” može eventualno smatrati medicinskom.
In the absence of details in the instructions for use or technical documentation and in view of the other claims and the advertising for the device focusing on obtaining a ‘flat stomach’, it is fair to assume that the digestive problems in question are nothing out of the ordinary.
U nedostatku pojašnjenja u uputama za uporabu ili tehničke dokumentacije te uzimajući u obzir druge namjene i oglašavanje proizvoda koje je usmjereno na postizanje „ravnog trbuha”, može se pretpostaviti da je riječ o probavnim smetnjama manjeg značaja.
All in all, the device appears to be of little benefit in medical terms.
Sve u svemu, korist proizvoda u medicinskom smislu nije značajna.
In view of this, the French authorities were able to conclude that the device does not comply with the essential requirements of the Directive with regard to the risk/benefit ratio.
S obzirom na to, francuska tijela mogla su zaključiti da proizvod ne poštuje bitne zahtjeve Direktive u pogledu odnosa rizika i koristi.
This conclusion is confirmed by the failure to comply with the essential requirement concerning clinical evaluation.
Taj je zaključak potvrđen u pogledu nepoštovanja bitnog zahtjeva o kliničkoj ocjeni.
Section 6a of Annex I to Directive 93/42/EEC provides: ‘Demonstration of conformity with the essential requirements must include a clinical evaluation in accordance with Annex X’.
U točki 6.a Priloga I. Direktivi 93/42/EEZ utvrđeno je sljedeće: „Dokaz o sukladnosti s bitnim zahtjevima mora sadržavati kliničku ocjenu u skladu s Prilogom X”.
Section 1.1 of Annex X (clinical evaluation) to the Directive provides: ‘As a general rule, confirmation of conformity with the requirements concerning the characteristics and performances referred to in Sections 1 and 3 of Annex I, under the normal conditions of use of the device, and the evaluation of the side-effects and of the acceptability of the benefit/risk ratio referred to in Section 6 of Annex I, must be based on clinical data’.
U točki 1.1. Priloga X. (klinička ocjena) Direktive utvrđeno je sljedeće: „Općenito je pravilo da se potvrda o sukladnosti s obzirom na zahtjeve vezano uz svojstva i učinkovitost iz odjeljaka 1. i 2. Priloga I. u uobičajenim uvjetima uporabe proizvoda i ocjena neželjenih popratnih pojava i prihvatljivost omjera koristi/rizika iz odjeljka 5. Priloga I., moraju temeljiti na kliničkim podacima.”
In the present case, as regards the benefits, the device is intended to ‘prevent digestive problems, reduce digestive discomfort, restore digestive comfort and reduce abdominal circumference’, as indicated above.
U ovom slučaju, kao što je prethodno navedeno, kada je riječ o koristima, proizvod je namijenjen „sprečavanju i smanjenju probavnih smetnji, olakšavanju probave i smanjenju opsega struka”.
However, the conclusions of the clinical evaluation report prepared by the NAMSA laboratory at the manufacturer's request, and based on all the data available, state that three clinical claims were examined ( ‘reduces digestive discomfort, helps to reduce the circumference of the waist, allows digestive comfort to be rapidly improved’) and that only the two claims associated with reducing digestive discomfort and reducing the circumference of the waist are considered to be backed up by clinical data.
Međutim, u zaključcima izvješća o kliničkoj ocjeni koje je sastavio laboratorij NAMSA na zahtjev proizvođača i na temelju svih raspoloživih podataka, navodi se da su ispitane tri kliničke namjene ( „smanjuje probavne smetnje, pomaže u smanjenju opsega struka, omogućuje brzo poboljšanje probave”) i da su kliničkim podacima potkrijepljene samo dvije namjene, one koje se odnose na smanjenje probavnih smetnji i smanjenje opsega struka.
The fourth claim associated with preventing digestive problems is not mentioned in the conclusions of this clinical assessment report.
Četvrta namjena koja se odnosi na sprečavanje probavnih smetnji nije navedena u zaključcima tog izvješća o kliničkoj ocjeni.
The manufacturer therefore did not provide clinical data to support the existence of all the beneficial effects claimed and in particular the existence of a beneficial effect in terms of preventing digestive problems.
Proizvođač stoga nije dostavio kliničke podatke kojima bi se potkrijepili svi navedeni korisni učinci, a posebno oni koji se odnose na sprečavanje probavnih smetnji.
The assessment of the clinical data therefore does not confirm that the device complies with the essential requirement relating to the risk/benefit ratio.
Iz toga slijedi da ocjena kliničkih podataka ne potvrđuje je li proizvod u skladu s bitnim zahtjevom koji se odnosi na omjer koristi i rizika.
In view of this, it was possible to conclude that the device does not comply with the essential requirement relating to the clinical evaluation, in connection with the essential requirement relating to the risk/benefit ratio.
S obzirom na prethodno navedeno, moglo se zaključiti da proizvod nije u skladu s bitnim zahtjevom koji se odnosi na kliničku ocjenu, u vezi s bitnim zahtjevom koji se odnosi na omjer koristi i rizika.
Essential requirements relating to minimising risk
Bitni zahtjevi povezani sa svođenjem rizika na najmanju moguću mjeru
Section 7.2 of Annex I to Directive 93/42/EEC provides: ‘The devices must be designed, manufactured and packed in such a way as to minimise the risk posed by contaminants and residues to the persons involved in the transport, storage and use of the devices and to the patients, taking account of the intended purpose of the product. Particular attention must be paid to the tissues exposed and to the duration and frequency of exposure’.
U točki 7.2.
Section 7.5 of Annex I to the Directive provides: ‘The devices must be designed and manufactured in such a way as to reduce to a minimum the risks posed by substances leaking from the device. Special attention shall be given to substances which are carcinogenic, mutagenic or toxic to reproduction, in accordance with Annex I to Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances […]’.
Priloga I. Direktivi 93/42/EEZ utvrđeno je sljedeće: „Proizvodi moraju biti projektirani, proizvedeni i zapakirani tako da opasnost od kontaminacije i ostataka po osobe uključene u prijevoz, skladištenje i uporabu proizvoda kao i pacijenta bude na najmanjoj mjeri vodeći računa o namjeni proizvoda. Posebna pozornost mora se pridavati izloženim tkivima, te trajanju i učestalosti izloženosti.” U točki 7.5. Priloga I. toj direktivi utvrđeno je sljedeće: „Proizvodi moraju biti projektirani i proizvedeni tako da se dovedu na najmanju moguću mjeru rizici od tvari koje izlaze iz proizvoda. Posebna se pažnja pridaje tvarima koje su kancerogene, mutagene ili toksične za reprodukciju u skladu s Prilogom I. Direktivi Vijeća 67/548/EEZ od 27. lipnja 1967. o usklađivanju zakona i drugih propisa vezano uz razvrstavanje, pakiranje i označavanje opasnih tvari […]”.
Annex I to Council Directive 67/548/EEC has become Part 3 of Annex VI to Regulation (EC) No 1272/2008 of the European Parliament and of the Council.
Prilog I. Direktivi Vijeća 67/548/EEZ postao je dio 3. Priloga VI. Uredbi (EZ) br. 1272/2008 Europskog parlamenta i Vijeća.
It follows from the above that use of the device poses a risk to the health or safety of patients (points 20-26), which it is the manufacturer's responsibility to reduce to a minimum.
Iz navedenog slijedi da uporaba proizvoda uključuje rizik za zdravlje ili za sigurnost pacijenata (uvodne izjave od 20. do 26.) koji proizvođač mora svesti na najmanju moguću mjeru.
Moreover, lead is described as a substance toxic to reproduction in Part 3 of Annex VI to Regulation (EC) No 1272/2008; it is also considered to be a ‘substance of very high concern’ by the European Chemicals Agency (ECHA), which justifies special attention being paid to it.
Osim toga, olovo je u skladu s dijelom 3. Priloga VI. Uredbi (EZ) br. 1272/2008 razvrstano u reproduktivno toksične tvari, a Europska agencija za kemikalije (ECHA) također smatra da je ono „posebno zabrinjavajuća tvar”; iz navedenog slijedi da je olovu potrebno posvetiti posebnu pozornost.
For the manufacturer of a medical device, the above-mentioned essential requirements may involve choosing batches of raw materials posing the least risk in terms of the toxic substances which they contain, i.e. verifying the concentration of a harmful substance in the batches of the raw material and selecting the batches showing a concentration which is compatible with the state of the art. In the present case, the raw material which forms part of the composition of the device, namely clay, contains harmful substances, in particular lead, in concentrations which may vary as it is a raw material of natural origin.
Na temelju navedenih bitnih zahtjeva proizvođač određenog medicinskog proizvoda mogao bi odabrati serije sirovina koje predstavljaju najmanji rizik u pogledu toksičnih tvari koje sadržavaju, tj. mogao bi provjeriti koncentraciju štetne tvari u serijama sirovina i odabrati serije u kojima je koncentracija tih tvari u skladu s najnovijim spoznajama. U ovom slučaju sirovina koja ulazi u sastav proizvoda, tj. glina, sadržava štetne tvari, konkretno olovo, u različitim koncentracijama jer je riječ o sirovini prirodnog podrijetla.
The French authorities, like the Belgian authorities, have shown that there is a high degree of variation in the lead levels of different batches of capsules of the device.
Francuska i belgijska tijela utvrdila su znatne varijacije udjela olova u različitim serijama kapsula proizvoda.
The manufacturer had the option of checking the lead content of the different batches of clay prior to manufacture and of selecting only those batches whose low lead content would have guaranteed that the capsules manufactured from this raw material contained a concentration lower than the threshold in Guideline ICH Q3D.
Proizvođač je prije proizvodnje imao priliku provjeriti udio olova u različitim serijama gline i odabrati samo serije s niskim udjelom olova, čime bi se zajamčilo da će koncentracija olova u kapsulama proizvedenima iz te sirovine biti niža od graničnih vrijednosti određenih u Smjernicama ICH Q3D.
However, under the contract between the manufacturer and its supplier, the batches of raw material were tested to determine their lead concentration and the manufacturer accepted batches whose lead concentration did not exceed 15 ppm, which equates to 15 μg/g.
Prema ugovoru između proizvođača i njegova dobavljača serije sirovina testirane su na koncentraciju olova i proizvođač je prihvatio serije u kojima je koncentracija olova bila niža od 15 ppm. Udio od 15 ppm jednak je koncentraciji od 15 μg/g.
Given that a daily treatment of six capsules corresponds to 2 g, the quantity of lead ingested by patients could reach 30 μg per day, i.e. much more than the threshold of 5 μg per day.
Uzimajući u obzir da dnevna doza od 6 kapsula odgovara masi od 2 g, dnevna količina olova koju pacijenti unose može dostići 30 μg, odnosno znatno više od granične vrijednosti od 5 μg dnevno.
The manufacturer has therefore not reduced as far as possible the risk associated with the presence of lead in the device by selecting batches of raw material which would have made it possible to manufacture a device containing a level of lead below the threshold set by Guideline ICH Q3D.
Prema tome, proizvođač nije sveo na najmanju moguću mjeru rizik povezan s prisutnošću olova u proizvodu odabirom serija sirovina iz kojih bi se mogli proizvesti proizvodi s udjelom olova nižim od graničnih vrijednosti određenih u Smjernicama ICH Q3D.
The above-mentioned essential requirements may also lead the manufacturer of a device to select, from different raw materials, the one which poses the fewest risks as regards the toxic substances which it contains.
Na temelju navedenih bitnih zahtjeva proizvođač određenog proizvoda mogao bi među različitim sirovinama odabrati one koja predstavljaju najmanji rizik s obzirom na toksične tvari koje sadržavaju.
Indeed, Section 7.1 of Annex I to the Directive provides that ‘particular attention must be paid to the choice of materials used, particularly as regards toxicity […]’.
U točki 7.1. Priloga I. Direktivi predviđeno je da se „posebna pozornost mora […] pridavati izboru korištenih materijala, posebno u odnosu na toksičnost […]”.
In the present case, other raw materials — such as, for example, activated charcoal, simeticone or dimeticone — have properties similar to clay and are likely to achieve the medical purpose claimed by the manufacturer for its device, namely ‘to prevent digestive problems’.
U ovom slučaju i druge sirovine, primjerice aktivni ugljen, simetikon ili dimetikon, imaju slična svojstva kao glina i mogle bi se upotrijebiti za istu medicinsku namjenu koju proizvođač navodi za svoj proizvod, tj. za „sprečavanje probavnih smetnji”.
These other raw materials are not known to contain lead and are therefore unlikely to pose the risks associated with the device in question.
Te druge sirovine ne sadržavaju olovo i stoga ne mogu dovesti do rizika do kojih dovodi predmetni proizvod.