natgillin/translations-raw huggingface dataset:
Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, p. 1).’.
30.).
ANNEXES
Preporuka Komisije 2011/696/EU od 18. listopada 2011. o definiciji nanomaterijala (SL L 275, 20.10.2011., str.
I General safety and performance requirements
38.).
II Technical documentation
Direktiva 2014/30/EU Europskog parlamenta i Vijeća od 26. veljače 2014. o usklađivanju zakonodavstava država članica u odnosu na elektromagnetsku kompatibilnost (SL L 96, 29.3.2014., str.
III Technical documentation on post-market surveillance
79.).
IV EU declaration of conformity
Direktiva Vijeća 2013/59/Euratom od 5. prosinca 2013. o osnovnim sigurnosnim standardima za zaštitu od opasnosti koje potječu od izloženosti ionizirajućem zračenju, i o stavljanju izvan snage direktiva 89/618/Euratom, 90/641/Euratom, 96/29/Euratom, 97/43/Euratom i 2003/122/Euratom (SL L 13, 17.1.2014., str.
V CE marking of conformity
1.).
VI Information to be submitted upon the registration of devices and economic operators in accordance with Articles 29(4) and 31; core data elements to be provided to the UDI database together with the UDI-DI in accordance with Articles 28 and 29;and the UDI system
Direktiva (EU) 2015/1535 Europskog parlamenta i Vijeća od 9. rujna 2015. o utvrđivanju postupka pružanja informacija u području tehničkih propisa i pravila o uslugama informacijskog društva (SL L 241, 17.9.2015., str.
VII Requirements to be met by notified bodies
1.).
VIII Classification rules
Uredba (EU) br.
IX Conformity assessment based on a quality management system and assessment of the technical documentation
1025/2012 Europskog parlamenta i Vijeća od 25. listopada 2012. o europskoj normizaciji, o izmjeni direktiva Vijeća 89/686/EEZ i 93/15/EEZ i direktiva 94/9/EZ, 94/25/EZ, 95/16/EZ, 97/23/EZ, 98/34/EZ, 2004/22/EZ, 2007/23/EZ, 2009/23/EZ i 2009/105/EZ Europskog parlamenta i Vijeća te o stavljanju izvan snage Odluke Vijeća 87/95/EEZ i Odluke br.
X Conformity assessment based on type examination
1673/2006/EZ Europskog parlamenta i Vijeća (SL L 316, 14.11.2012., str.
XI Conformity assessment based on product conformity verification
12.).
XII Certificates issued by a notified body
Direktiva 98/79/EZ Europskog parlamenta i Vijeća od 27. listopada 1998. o in vitro dijagnostičkim medicinskim proizvodima (SL L 331, 7.12.1998., str. 1.).
XIII Procedure for custom-made devices
Uredba (EZ) br. 765/2008 Europskog parlamenta i Vijeća od 9. srpnja 2008. o utvrđivanju zahtjeva za akreditaciju i za nadzor tržišta u odnosu na stavljanje proizvoda na tržište i o stavljanju izvan snage Uredbe (EEZ) br. 339/93 (SL L 218, 13.8.2008., str. 30.).
XIV Clinical evaluation and post-market clinical follow-up
Odluka br.
XV Clinical investigations
768/2008/EZ Europskog parlamenta i Vijeća od 9. srpnja 2008. o zajedničkom okviru za stavljanje na tržište proizvoda i o stavljanju izvan snage Odluke Vijeća 93/465/EEZ (SL L 218, 13.8.2008, str.
XVI List of groups of products without an intended medical purpose referred to in Article 1(2)
82.).
XVII Correlation table
Direktiva Vijeća 85/374/EEZ od 25. srpnja 1985. o usklađivanju zakona i drugih propisa država članica u vezi s odgovornošću za neispravne proizvode (SL L 210., 7.8.1985., str. 29.).
ANNEX I
Presuda Suda od 28. srpnja 2011. u Orifarm i Paranova, spojeni predmeti C-400/09 i C-207/10, ECLI:EU:C:2011:519.
GENERAL SAFETY AND PERFORMANCE REQUIREMENTS
Odluka Komisije 2010/227/EU od 19. travnja 2010. o Europskoj bazi podataka za medicinske proizvode (Eudamed) (SL L 102, 23.4.2010., str.
GENERAL REQUIREMENTS
45.).
Devices shall achieve the performance intended by their manufacturer and shall be designed and manufactured in such a way that, during normal conditions of use, they are suitable for their intended purpose.
Direktiva 95/46/EZ Europskog parlamenta i Vijeća od 24. listopada 1995. o zaštiti pojedinaca u vezi s obradom osobnih podataka i o slobodnom protoku takvih podataka (SL L 281, 23.11.1995., str. 31.).
They shall be safe and effective and shall 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, taking into account the generally acknowledged state of the art.
Uredba (EZ) br.
The requirement in this Annex to reduce risks as far as possible means the reduction of risks as far as possible without adversely affecting the benefit-risk ratio.
45/2001 Europskog parlamenta i Vijeća od 18. prosinca 2000. o zaštiti pojedinaca u vezi s obradom osobnih podataka u institucijama i tijelima Zajednice i o slobodnom kretanju takvih podataka (SL L 8, 12.1.2001., str.
Manufacturers shall establish, implement, document and maintain a risk management system.
1.).
Risk management shall be understood as a continuous iterative process throughout the entire lifecycle of a device, requiring regular systematic updating.
Direktiva 2010/63/EU Europskog parlamenta i Vijeća od 22. rujna 2010. o zaštiti životinja koje se koriste u znanstvene svrhe (SL L 276, 20.10.2010., str.
In carrying out risk management manufacturers shall:
33.).
identify and analyse the known and foreseeable hazards associated with each device;
SL L 123, 12.5.2016., str.
estimate and evaluate the risks associated with, and occurring during, the intended use and during reasonably foreseeable misuse;
1.
eliminate or control the risks referred to in point (c) in accordance with the requirements of Section 4;
Uredba (EU) br. 182/2011 Europskog parlamenta i Vijeća od 16. veljače 2011. o utvrđivanju pravila i općih načela u vezi s mehanizmima nadzora država članica nad izvršavanjem provedbenih ovlasti Komisije (SL L 55, 28.2.2011., str. 13.).
evaluate the impact of information from the production phase and, in particular, from the post-market surveillance system, on hazards and the frequency of occurrence thereof, on estimates of their associated risks, as well as on the overall risk, benefit-risk ratio and risk acceptability; and
Uredba Komisije (EU) br.
based on the evaluation of the impact of the information referred to in point (e), if necessary amend control measures in line with the requirements of Section 4.
207/2012 od 9. ožujka 2012. o elektronskim uputama za uporabu medicinskih proizvoda (SL L 72, 10.3.2012., str.
Risk control measures adopted by manufacturers for the design and manufacture of the devices shall conform to safety principles, taking account of the generally acknowledged state of the art.
28.).
To reduce risks, Manufacturers shall manage risks so that the residual risk associated with each hazard as well as the overall residual risk is judged acceptable.
Uredba Komisije (EU) br.
In selecting the most appropriate solutions, manufacturers shall, in the following order of priority:
722/2012 od 8. kolovoza 2012. o posebnim zahtjevima u vezi sa zahtjevima utvrđenim u direktivama Vijeća 90/385/EEZ i 93/42/EEZ s obzirom na aktivne medicinske proizvode za ugradnju i medicinske proizvode proizvedene korištenjem tkiva životinjskog podrijetla (SL L 212, 9.8.2012., str.
eliminate or reduce risks as far as possible through safe design and manufacture;
3.).
where appropriate, take adequate protection measures, including alarms if necessary, in relation to risks that cannot be eliminated; and
Direktiva Komisije 2003/12/EZ od 3. veljače 2003. o ponovnoj klasifikaciji implantata za dojke u okviru Direktive 93/42/EEZ u pogledu medicinskih proizvoda (SL L 28, 4.2.2003., str.
provide information for safety (warnings/precautions/contra-indications) and, where appropriate, training to users.
43.).
Manufacturers shall inform users of any residual risks.
Direktiva Komisije 2005/50/EZ od 11. kolovoza 2005. o ponovnoj kategorizaciji zglobnih proteza kuka, koljena i ramena u okviru Direktive Vijeća 93/42/EEZ o medicinskim proizvodima (SL L 210, 12.8.2005., str.
In eliminating or reducing risks related to use error, the manufacturer shall:
41.).
reduce as far as possible the risks related to the ergonomic features of the device and the environment in which the device is intended to be used (design for patient safety), and
Provedbena uredba Komisije (EU) br.
give consideration to the technical knowledge, experience, education, training and use environment, where applicable, and the medical and physical conditions of intended users (design for lay, professional, disabled or other users).
920/2013 od 24. rujna 2013. o imenovanju i nadziranju prijavljenih tijela na temelju Direktive Vijeća 90/385/EEZ o aktivnim medicinskim proizvodima za ugradnju i Direktive Vijeća 93/42/EEZ o medicinskim proizvodima (SLL 253, 25.9.2013., str.
The characteristics and performance of a device shall not be adversely affected to such a degree that the health or safety of the patient or the user and, where applicable, of other persons are compromised during the lifetime of the device, as indicated by the manufacturer, when the device is subjected to the stresses which can occur during normal conditions of use and has been properly maintained in accordance with the manufacturer's instructions.
8.).
Devices shall be designed, manufactured and packaged in such a way that their characteristics and performance during their intended use are not adversely affected during transport and storage, for example, through fluctuations of temperature and humidity, taking account of the instructions and information provided by the manufacturer.
SL C 358, 7.12.2013., str.
All known and foreseeable risks, and any undesirable side-effects, shall be minimised and be acceptable when weighed against the evaluated benefits to the patient and/or user arising from the achieved performance of the device during normal conditions of use.
10.
For the devices referred to in Annex XVI, the general safety requirements set out in Sections 1 and 8 shall be understood to mean that the device, when used under the conditions and for the purposes intended, does not present a risk at all or presents a risk that is no more than the maximum acceptable risk related to the product's use which is consistent with a high level of protection for the safety and health of persons.
Uredba (EZ) br. 726/2004 Europskog parlamenta i Vijeća od 31. ožujka 2004. o utvrđivanju postupaka odobravanja primjene i postupaka nadzora nad primjenom lijekova koji se rabe u humanoj i veterinarskoj medicini, te uspostavi Europske agencije za lijekove (SL L 136, 30.4.2004., str. 1.).
REQUIREMENTS REGARDING DESIGN AND MANUFACTURE
Direktiva 2006/42/EZ Europskog parlamenta i Vijeća od 17. svibnja 2006. o strojevima (SL L 157, 9.6.2006., str. 24.).
Chemical, physical and biological properties
Preporuka Komisije 2003/361/ΕZ od 6. svibnja 2003. o definiciji mikro, malih i srednjih poduzeća (SL L 124, 20.5.2003., str.
Devices shall be designed and manufactured in such a way as to ensure that the characteristics and performance requirements referred to in Chapter I are fulfilled.
36.).
Particular attention shall be paid to:
Uredba (EU) br.
the choice of materials and substances used, particularly as regards toxicity and, where relevant, flammability;
536/2014 Europskog parlamenta i Vijeća od 16. travnja 2014. o kliničkim ispitivanjima lijekova za primjenu kod ljudi te o stavljanju izvan snage Direktive 2001/20/EZ (SL L 158, 27.5.2014., str.
the compatibility between the materials and substances used and biological tissues, cells and body fluids, taking account of the intended purpose of the device and, where relevant, absorption, distribution, metabolism and excretion;
1.).
the compatibility between the different parts of a device which consists of more than one implantable part;
Uredba (EU) 2017/745 Europskog parlamenta i Vijeća od 5. travnja 2017. o medicinskim proizvodima, o izmjeni Direktive 2001/83/EZ, Uredbe (EZ) br.
the impact of processes on material properties;
178/2002 i Uredbe (EZ) br.
where appropriate, the results of biophysical or modelling research the validity of which has been demonstrated beforehand;
1223/2009 te o stavljanju izvan snage direktiva Vijeća 90/385/EEZ i 93/42/EEZ (SL L 117, 5.5.2017., str.
surface properties; and
Uredba (EU) 2017/745 Europskog parlamenta i Vijeća od 5. travnja 2017. o medicinskim proizvodima i o izmjeni Direktive 2001/83/EZ, Uredbe (EZ) br.
the confirmation that the device meets any defined chemical and/or physical specifications.
178/2002 i Uredbe (EZ) br.
Devices shall be designed, manufactured and packaged in such a way as to minimise the risk posed by contaminants and residues to patients, taking account of the intended purpose of the device, and to the persons involved in the transport, storage and use of the devices.
1223/2009 te o stavljanju izvan snage direktiva Vijeća 90/385/EEZ i 93/42/EEZ (SL L 117, 5.5.2017., str.
Particular attention shall be paid to tissues exposed to those contaminants and residues and to the duration and frequency of exposure.
1.).”
Devices shall be designed and manufactured in such a way that they can be used safely with the materials and substances, including gases, with which they enter into contact during their intended use; if the devices are intended to administer medicinal products they shall be designed and manufactured in such a way as to be compatible with the medicinal products concerned in accordance with the provisions and restrictions governing those medicinal products and that the performance of both the medicinal products and of the devices is maintained in accordance with their respective indications and intended use.
PRILOZI
Substances
I. Opći zahtjevi sigurnosti i učinkovitosti
Design and manufacture of devices
Tehnička dokumentacija
Devices shall be designed and manufactured in such a way as to reduce as far as possible the risks posed by substances or particles, including wear debris, degradation products and processing residues, that may be released from the device.
Tehnička dokumentacija o posttržišnom nadzoru
Devices, or those parts thereof or those materials used therein that:
EU izjava o sukladnosti
are invasive and come into direct contact with the human body,
V. Oznaka sukladnosti CE
(re)administer medicines, body liquids or other substances, including gases, to/from the body, or
Informacije koje se prilažu registraciji proizvoda i gospodarskih subjekata u skladu s člankom 29. stavkom 4. i člankom 31.; temeljni podatkovni elementi koje treba dostaviti u bazu podataka jedinstvene identifikacije proizvoda zajedno s UDI-DI-jem u skladu s člancima 28. i 29. te sustav jedinstvene identifikacije proizvoda
transport or store such medicines, body fluids or substances, including gases, to be (re)administered to the body,
Zahtjevi koje trebaju ispuniti prijavljena tijela
shall only contain the following substances in a concentration that is above 0,1 % weight by weight (w/w) where justified pursuant to Section 10.4.2:
Pravila razvrstavanja
substances which are carcinogenic, mutagenic or toxic to reproduction (‘CMR’), of category 1A or 1B, in accordance with Part 3 of Annex VI to Regulation (EC) No 1272/2008 of the European Parliament and of the Council [1], or
Ocjenjivanje sukladnosti na temelju sustava upravljanja kvalitetom i ocjenjivanja tehničke dokumentacije
substances having endocrine-disrupting properties for which there is scientific evidence of probable serious effects to human health and which are identified either in accordance with the procedure set out in Article 59 of Regulation (EC) No 1907/2006 of the European Parliament and of the Council [2] or, once a delegated act has been adopted by the Commission pursuant to the first subparagraph of Article 5(3) of Regulation (EU) No 528/2012 of the European Parliament and the Council [3], in accordance with the criteria that are relevant to human health amongst the criteria established therein.
Ocjenjivanje sukladnosti na temelju ispitivanja tipa
Justification regarding the presence of CMR and/or endocrine-disrupting substances
Ocjenjivanje sukladnosti na temelju provjere sukladnosti proizvoda
The justification for the presence of such substances shall be based upon:
Potvrde koje izdaje prijavljeno tijelo
an analysis and estimation of potential patient or user exposure to the substance;
Postupak za proizvode izrađene po narudžbi
an analysis of possible alternative substances, materials or designs, including, where available, information about independent research, peer-reviewed studies, scientific opinions from relevant scientific committees and an analysis of the availability of such alternatives;
Klinička procjena i posttržišno kliničko praćenje
argumentation as to why possible substance and/ or material substitutes, if available, or design changes, if feasible, are inappropriate in relation to maintaining the functionality, performance and the benefit-risk ratios of the product; including taking into account if the intended use of such devices includes treatment of children or treatment of pregnant or breastfeeding women or treatment of other patient groups considered particularly vulnerable to such substances and/or materials; and
Klinička ispitivanja
where applicable and available, the latest relevant scientific committee guidelines in accordance with Sections 10.4.3. and 10.4.4.
Popis skupina proizvoda bez medicinske namjene iz članka 1. stavka 2.
Guidelines on phthalates
Korelacijska tablica
For the purposes of Section 10.4., the Commission shall, as soon as possible and by 26 May 2018, provide the relevant scientific committee with a mandate to prepare guidelines that shall be ready before 26 May 2020.
PRILOG I.
The mandate for the committee shall encompass at least a benefit-risk assessment of the presence of phthalates which belong to either of the groups of substances referred to in points (a) and (b) of Section 10.4.1.
OPĆI ZAHTJEVI SIGURNOSTI I UČINKOVITOSTI
The benefit-risk assessment shall take into account the intended purpose and context of the use of the device, as well as any available alternative substances and alternative materials, designs or medical treatments.
OPĆI ZAHTJEVI
When deemed appropriate on the basis of the latest scientific evidence, but at least every five years, the guidelines shall be updated.
Proizvodi postižu učinkovitost koju im je namijenio njihov proizvođač te su projektirani i proizvedeni tako da u uobičajenim uvjetima uporabe odgovaraju svojoj namjeni.
Guidelines on other CMR and endocrine-disrupting substances
Sigurni su i učinkoviti te ne ugrožavaju kliničko stanje ili sigurnost pacijenata ili sigurnost i zdravlje korisnika ili, ako je to primjenjivo, drugih osoba, uz uvjet da svi rizici koji se mogu povezati s njihovom uporabom predstavljaju prihvatljive rizike u usporedbi s koristima za pacijenta te su kompatibilni s visokom razinom zaštite zdravlja i sigurnosti, uzimajući u obzir općepriznata najnovija dostignuća.
Subsequently, the Commission shall mandate the relevant scientific committee to prepare guidelines as referred to in Section 10.4.3. also for other substances referred to in points (a) and (b) of Section 10.4.1., where appropriate.
Zahtjev za svođenje rizika na najmanju moguću mjeru sadržan u ovom Prilogu odnosi se na svođenje rizika na najmanju moguću mjeru bez nepoželjnog utjecaja na omjer koristi i rizika.
Labelling
Proizvođači uspostavljaju, provode, dokumentiraju i održavaju sustav upravljanja rizicima.
Where devices, parts thereof or materials used therein as referred to in Section 10.4.1. contain substances referred to in points (a) or (b) of Section 10.4.1. in a concentration above 0,1 % weight by weight (w/w), the presence of those substances shall be labelled on the device itself and/or on the packaging for each unit or, where appropriate, on the sales packaging, with the list of such substances.
Upravljanje rizicima smatra se trajnim iterativnim procesom kojim je obuhvaćen cijeli životni vijek proizvoda i koji zahtijeva redovito sustavno ažuriranje.
If the intended use of such devices includes treatment of children or treatment of pregnant or breastfeeding women or treatment of other patient groups considered particularly vulnerable to such substances and/or materials, information on residual risks for those patient groups and, if applicable, on appropriate precautionary measures shall be given in the instructions for use.
Pri provedbi upravljanja rizicima proizvođači:
Devices shall be designed and manufactured in such a way as to reduce as far as possible the risks posed by the unintentional ingress of substances into the device taking into account the device and the nature of the environment in which it is intended to be used.
uspostavljaju i dokumentiraju plan upravljanja rizicima za svaki proizvod;
Devices shall be designed and manufactured in such a way as to reduce as far as possible the risks linked to the size and the properties of particles which are or can be released into the patient's or user's body, unless they come into contact with intact skin only.
identificiraju i analiziraju poznate i predvidljive opasnosti povezane sa svakim proizvodom;
Special attention shall be given to nanomaterials.
ocjenjuju i procjenjuju rizike koji se pojavljuju tijekom predviđene uporabe i tijekom razumno predvidljive pogrešne uporabe i koji su s njima povezani;
Infection and microbial contamination
uklanjaju ili kontroliraju rizike navedene u točki (c) u skladu sa zahtjevima iz odjeljka 4.;
Devices and their manufacturing processes shall be designed in such a way as to eliminate or to reduce as far as possible the risk of infection to patients, users and, where applicable, other persons.
procjenjuju utjecaj informacija proizašlih iz faze proizvodnje te, osobito, iz sustava posttržišnog nadzora, o opasnostima i njihovoj učestalosti pojavljivanja, o ocjenama njihovih pripadajućih rizika, kao i o cjelokupnom riziku, omjeru koristi i rizika te prihvatljivosti rizika; i
The design shall:
na temelju procjene utjecaja informacija iz točke (e), ako je potrebno, izmjenjuju mjere kontrole u skladu sa zahtjevima iz odjeljka 4.
reduce as far as possible and appropriate the risks from unintended cuts and pricks, such as needle stick injuries,
Mjere kontrole rizika koje proizvođači usvoje za projektiranje i proizvodnju proizvoda sukladne su s načelima sigurnosti, uzimajući u obzir općepriznata najnovija dostignuća.
allow easy and safe handling,
Radi smanjenja rizika, proizvođači upravljaju rizicima tako da se preostali rizik povezan sa svakom opasnošću, kao i cjelokupni preostali rizik ocijeni kao prihvatljiv.
reduce as far as possible any microbial leakage from the device and/or microbial exposure during use, and
Pri odabiru najprikladnijih rješenja proizvođači, prema sljedećem redoslijedu prvenstva:
prevent microbial contamination of the device or its content such as specimens or fluids.
uklanjaju ili svode rizike na najmanju moguću mjeru sigurnim projektiranjem i proizvodnjom;
Where necessary devices shall be designed to facilitate their safe cleaning, disinfection, and/or re-sterilisation.
prema potrebi poduzimaju odgovarajuće zaštitne mjere u vezi s rizicima koji se ne mogu ukloniti, uključujući alarme ako je potrebno; te
Devices labelled as having a specific microbial state shall be designed, manufactured and packaged to ensure that they remain in that state when placed on the market and remain so under the transport and storage conditions specified by the manufacturer.
pružaju informacije o sigurnosti (upozorenja / mjere opreza / kontraindikacije) te, prema potrebi, izobrazbu korisnicima.
Devices delivered in a sterile state shall be designed, manufactured and packaged in accordance with appropriate procedures, to ensure that they are sterile when placed on the market and that, unless the packaging which is intended to maintain their sterile condition is damaged, they remain sterile, under the transport and storage conditions specified by the manufacturer, until that packaging is opened at the point of use.
Proizvođači obavješćuju korisnike o svim preostalim rizicima.