natgillin/translations-raw huggingface dataset:
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.
Štoviše, u izvješću laboratorija NAMSA koje navodi proizvođač potvrđuje se da postoji rizik zbog prisutnosti olova u proizvodu, no smatra se niskim.
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.
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.
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.
Kada je riječ o koristima, prema uputama za uporabu proizvod je namijenjen „sprečavanju i smanjenju probavnih smetnji, olakšavanju probave i smanjenju opsega struka”.
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’.
Valja podsjetiti da u skladu s člankom 1. stavkom 2.
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.
Direktive medicinski proizvod podrazumijeva medicinsku namjenu.
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.
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.
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.
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.
Priloga I. u uobičajenim uvjetima uporabe proizvoda i ocjena neželjenih popratnih pojava i prihvatljivost omjera koristi/rizika iz odjeljka 5.
The fourth claim associated with preventing digestive problems is not mentioned in the conclusions of this clinical assessment report.
Priloga I., moraju temeljiti na kliničkim podacima.”
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.
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”.
The assessment of the clinical data therefore does not confirm that the device complies with the essential requirement relating to the risk/benefit ratio.
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.
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.
Četvrta namjena koja se odnosi na sprečavanje probavnih smetnji nije navedena u zaključcima tog izvješća o kliničkoj ocjeni.
Essential requirements relating to minimising risk
Proizvođač stoga nije dostavio kliničke podatke kojima bi se potkrijepili svi navedeni korisni učinci, a posebno oni koji se odnose na sprečavanje probavnih smetnji.
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.
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.
Particular attention must be paid to the tissues exposed and to the duration and frequency of exposure’.
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.
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.
Bitni zahtjevi povezani sa svođenjem rizika na najmanju moguću mjeru
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 […]’.
U točki 7.2.
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.
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.
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.
Posebna pozornost mora se pridavati izloženim tkivima, te trajanju i učestalosti izloženosti.”
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.
U točki 7.5.
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.
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.
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.
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 […]”.
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.
Prilog I. Direktivi Vijeća 67/548/EEZ postao je dio 3.
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.
Priloga VI.
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.
Uredbi (EZ) br. 1272/2008 Europskog parlamenta i Vijeća.
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.
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.
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.
Osim toga, olovo je u skladu s dijelom 3.
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.
Priloga VI.
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 […]’.
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.
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’.
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.
These other raw materials are not known to contain lead and are therefore unlikely to pose the risks associated with the device in question.
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 manufacturer did not, however, try to find an alternative raw material uncontaminated with toxic substances (see its email of 30 March 2018).
Francuska i belgijska tijela utvrdila su znatne varijacije udjela olova u različitim serijama kapsula proizvoda.
It has therefore not reduced as far as possible the risk associated with the presence of lead in the device in this way.
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.
In view of this, the French authorities were able to conclude that the device did not comply with the essential requirements of the Directive with regard to minimising risk.
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.
Objections raised by the manufacturer concerning failure to comply with essential requirements
Udio od 15 ppm jednak je koncentraciji od 15 μg/g.
The manufacturer calls into question the use of Guideline ICH Q3D.
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.
It argues in particular that the Guideline is not applicable ratione materiae — it applies to medicinal products — and ratione temporis — it applies to new applications for authorisation to place medicinal products on the market as of June 2016 and to existing authorisations to place medicinal products on the market as of December 2017 — and that its application runs counter to the principles of legality and legal certainty.
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.
However, use of Guideline ICH Q3D is in keeping with Article 8(1) of the Directive, which requires a Member State to take certain interim measures if it notices that a medical device poses a risk to safety and/or health, and which does not limit the information which the Member State may draw on to show that such a risk exists.
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.
Moreover, for the reasons mentioned above (point (24), while being formally applicable to medicinal products, the Guideline is relevant in identifying the risk associated with the presence of lead in a medical device whose situation is similar to that of a medicinal product.
U točki 7.1.
It follows that use of the Guideline appears to have a legal basis and be predictable.
Priloga I. Direktivi predviđeno je da se „posebna pozornost mora […] pridavati izboru korištenih materijala, posebno u odnosu na toksičnost […]”.
The manufacturer calls into question the method used to evaluate the risk.
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”.
It argues, in particular, that this method, based on the quantity of lead contained in the device, is not relevant in assessing compliance with the essential requirements which refer to substances released by a device and that it is not suitable for a device based on clay, which does not release its elements.
Te druge sirovine ne sadržavaju olovo i stoga ne mogu dovesti do rizika do kojih dovodi predmetni proizvod.
However, in the circumstances surrounding the present case, in the absence of an in vivo study making it possible to assess the quantity of lead actually released by the device, the method based on the quantity of the toxic substance contained in the device makes it possible to determine the quantity likely to be released into the body and thus to assess the risk posed by substances released by the device.
Međutim, proizvođač nije potražio alternativnu sirovinu koja nije kontaminirana toksičnim tvarima (vidjeti njegovu poruku e-pošte od 30. ožujka 2018.).
It should also be pointed out, first, that the fact that the device releases a certain amount of lead is not disputed (as shown by tests carried out by the manufacturer itself) and, second, that while the manufacturer considers the amount of lead released to be small, the method used by the manufacturer to reach this conclusion is disputable (see points 47 et seq. below).
Prema tome, on na taj način nije sveo na najmanju moguću mjeru rizik povezan s prisutnošću olova u proizvodu.
The manufacturer argues that even if Guideline ICH Q3D were used, the amount of lead released (which it assesses at 3,126 μg per day in its communication of 30 November 2016, and which is estimated at 3,96 μg per day in the report of February 2017 by the NAMSA laboratory) would be below the threshold mentioned in Guideline ICH Q3D (which is 5 μg per day).
S obzirom na to, francuska tijela mogla su zaključiti da proizvod ne poštuje bitne zahtjeve Direktive koji se odnose na svođenje rizika na najmanju moguću mjeru.
However, the method used by the manufacturer to determine the quantity of lead released by the device is disputable (see points 47 et seq. below) and therefore does not make it possible to tell whether the quantity determined using this method is so low that it does not pose a risk, taking into consideration Guideline ICH Q3D and other reference documents.
Prigovori koje je uložio proizvođač u pogledu nepoštovanja bitnih zahtjeva
The manufacturer argues that the (cardiovascular, neurological and nephrotoxic) risks identified by the French authorities were taken into account through the indications the instructions for use of the device, with the result that the device complies with the essential requirement of Section 1 of Annex I to the Directive.
Proizvođač dovodi u pitanje primjenu Smjernica ICH Q3D.
It also argues that excessive exposure to lead may be avoided through measures taken by the manufacturer such as indications in the instructions for use, with the result that a measure taken by the authorities which, among other things, prohibits the device from being placed on the market and requires it to be withdrawn from the market, runs counter to the principle of proportionality.
On osobito naglašava da se Smjernice ne mogu primijeniti ratione materiae (jer se primjenjuju na lijekove) i ratione temporis (jer se od lipnja 2016. primjenjuju na nove zahtjeve za odobrenje za stavljanje u promet lijekova, a od prosinca 2017. na postojeća odobrenja za stavljanje u promet lijekova) te da je njihova primjena u suprotnosti s načelima zakonitosti i pravne sigurnosti.
However, the indications added to the instructions for use by the manufacturer restricting use of the device with regard to certain patients (children, pregnant women and individuals with kidney disease) do not eliminate the risk of lead poisoning for the population as a whole.
Međutim, primjena Smjernica ICH Q3D temelji se na članku 8. stavku 1.
An in vivo study showing that the quantity of lead actually released by the device is lower than the threshold indicated in the Guideline would help to eliminate the risk of excessive exposure to lead.
Direktive, kojim se propisuje da je država članica dužna poduzeti sve odgovarajuće privremene mjere ako utvrdi da medicinski proizvod predstavlja rizik za zdravlje i/ili sigurnost te se ne ograničavaju instrumenti kojima se država članica može poslužiti kako bi dokazala postojanje rizika.
Article 8(1) of Directive 93/42/EEC takes the proportionality principle into account by providing that where a risk to the health and/or safety of persons is ascertained, appropriate interim measures must be taken to withdraw the devices in question from the market or prohibit or restrict their being placed on the market.
Osim toga, zbog navedenih su se razloga (uvodna izjava 24.)
It follows in the present case that where the French authorities show that a risk of this kind exists, a measure consisting in suspending the placing on the market of the device and withdrawing the device from the distributors until it is brought into line with the regulations is in keeping with Article 8(1) of the Directive and with the principle of proportionality.
Smjernice, iako se službeno primjenjuju na lijekove, pokazale relevantnima za utvrđivanje rizika povezanog s olovom u medicinskom proizvodu koji je sličan lijeku.
In view of this, the objections raised by the manufacturer are not such as to call into question the French authorities' observation that the device does not comply with certain essential requirements of the Directive.
Iz toga proizlazi da je primjena Smjernica pravno utemeljena i predvidljiva.
Incorrect application of standards
Proizvođač dovodi u pitanje metodu procjene rizika.
It follows from Article 8(1) of Directive 93/42/EEC that the risk requiring the Member States to take measures may result from the incorrect application of the standards referred to in Article 5 of the Directive which the manufacturer claims to have applied.
Ističe da ta metoda, koja se temelji na količini olova u predmetnom proizvodu, nije relevantna za ocjenu sukladnosti s bitnim zahtjevima koji se odnose na tvari koje proizvod izlučuje te da nije prilagođena za ocjenjivanje proizvoda od gline, koji ne ispuštaju te elemente.
The manufacturer argues that the device was assessed and deemed compliant with certain harmonised standards concerning the biological evaluation of medical devices (in particular standards EN ISO 10993-1 2009/AC: 2010, EN ISO 10993-12 2012, EN ISO 10993-17 2009 and EN ISO 10993-18 2009), which correspond to certain essential requirements laid down in the Directive and a reference to which has been published in the Official Journal of the European Union, with the result that the device must be presumed to comply with the essential requirements in question.
Međutim, u danim okolnostima i u nedostatku studije in vivo kojom bi se procijenila stvarna količina olova koju proizvod izlučuje, predmetna metoda, koja se temelji na utvrđenoj količini toksične tvari sadržane u proizvodu, omogućuje utvrđivanje količine koja bi se mogla izlučiti u organizam i, prema tome, procjenu rizika od tvari koje proizvod ispušta.
These standards concerning the biological evaluation of medical devices provide in particular that the method used must reproduce the actual conditions of use of the medical device and that it may be necessary to conduct tests in addition to those described in the standards, as indicated by the provisions below.
Potrebno je napomenuti da se, s jedne strane, ne osporava da proizvod ispušta određenu količinu olova (što je utvrđeno prije svega testovima koje je proveo sam proizvođač), no s druge strane, iako proizvođač smatra da je razina ispuštanja niska, metoda kojom je došao do tog zaključka upitna je (vidjeti uvodnu izjavu 47. i dalje).
Standard EN ISO 10993-1 2010: biological evaluation of medical devices – evaluation and testing within a risk management process
Proizvođač ističe da bi i u slučaju primjene Smjernica ICH Q3D količina ispuštenog olova (koju on u svojem dopisu od 30. studenoga 2016. procjenjuje na 3,126 μg na dan, a koja je u izvješću laboratorija NAMSA iz veljače 2017. procijenjena na 3,96 μg na dan) bila niža od granične vrijednosti iz Smjernica ICH Q3D (koja iznosi 5 μg na dan).