natgillin/translations-raw huggingface dataset:
Certificates issued by notified bodies in accordance with Directive 98/79/EC from 25 May 2017 shall become void by 27 May 2024.
Kar zadeva pripomočke, za katere se uporabljajo postopki, določeni v členu 48(3) in (4), se uporablja odstavek 5 tega člena, pod pogojem, da so bila opravljena obvezna imenovanja v Koordinacijsko skupino za medicinske pripomočke, strokovne odbore in referenčne laboratorije EU.
By way of derogation from Article 5 of this Regulation, a device with a certificate that was issued in accordance with Directive 98/79/EC and which is valid by virtue of paragraph 2 of this Article may only be placed on the market or put into service provided that from the date of application of this Regulation it continues to comply with that Directive, and provided there are no significant changes in the design and intended purpose.
Z odstopanjem od člena 10 ter točk (a) in (b) člena 12(1) Direktive 98/79/ES se za proizvajalce, pooblaščene predstavnike, uvoznike in priglašene organe, ki v obdobju, ki se začne na poznejši od datumov iz točke (d) člena 113(3) in konča 18 mesecev pozneje, ki izpolnjujejo zahteve iz člena 27(3), člena 28(1) in člena 51(5) te uredbe, šteje, da izpolnjujejo zahteve iz zakonov in drugih predpisov, ki so jih države članice sprejele v skladu s členom 10 ter točkama (a) in (b) člena 12(1) Direktive 98/79/ES, kakor je določeno v Sklepu 2010/227/EU.
Without prejudice to Chapter IV and paragraph 1 of this Article, the notified body that issued the certificate referred to in the first subparagraph shall continue to be responsible for the appropriate surveillance in respect of all applicable requirements relating to the devices it has certified.
Dokler Komisija v skladu s členom 24(2) ne imenuje subjektov izdajateljev UDI, se GS1 HIBCC in ICCBBA štejejo za imenovane subjekte izdajatelje.
Devices lawfully placed on the market pursuant to Directive 98/79/EC prior to 26 May 2022 and devices placed on the market 26 May 2022 by virtue of a certificate as referred to in paragraph 2 of this Article, may continue to be made available on the market or put into service until 27 May 2025.
Člen 111
By way of derogation from Directive 98/79/EC, devices which comply with this Regulation may be placed on the market before 26 May 2022.
Ocena
By way of derogation from Directive 98/79/EC, conformity assessment bodies which comply with this Regulation may be designated and notified prior to 26 May 2022.
Komisija do 27. maja 2027 oceni uporabo te uredbe in pripravi poročilo o oceni napredka pri doseganju ciljev te uredbe, vključno z oceno sredstev, potrebnih za izvajanje te uredbe.
Notified bodies which are designated and notified in accordance with this Regulation may carry out the conformity assessment procedures laid down in this Regulation and issue certificates in accordance with this Regulation prior to 26 May 2022.
Posebna pozornost se nameni sledljivosti pripomočkov prek UDI, ki jo v skladu s členom 24 hranijo gospodarski subjekti, zdravstvene ustanove in zdravstveni delavci.
As regards devices subject to the procedures laid down in Article 48(3) and (4), paragraph 5 of this Article applies provided that the necessary appointments to the MDCG and expert panels and of EU reference laboratories have been made.
Ocena vključuje tudi pregled delovanja člena 4.
By way of derogation from Article 10 and points (a) and (b) of Article 12(1) of Directive 98/79/EC, manufacturers, authorised representatives, importers and notified bodies which, during the period starting on the later of the dates referred to in point (f) of Article 113(3) and ending 18 months later, comply with Article 27(3) and Article 28(1) and Article 51(5) of this Regulation shall be considered to comply with the laws and regulations adopted by Member States in accordance with Article 10 and points (a) and (b) of Article 12(1) of Directive 98/79/EC as specified in Decision 2010/227/EU.
Člen 112
Authorisations granted by the competent authorities of the Member States in accordance with Article 9(12) of Directive 98/79/EC shall keep the validity indicated in the authorisation.
Razveljavitev
Until the Commission has designated, pursuant to Article 24(2), issuing entities, GS1, HIBCC and ICCBBA shall be considered to be designated issuing entities.
Brez poseganja v člen 110(3) in (4) te uredbe ter brez poseganja v obveznosti, ki jih imajo na podlagi Direktive 98/79/ES države članice in proizvajalci glede vigilance ter proizvajalci glede omogočanja dostopnosti dokumentacije, se navedena direktiva razveljavi z učinkom od 26. maja 2022, razen:
Article 111
člena 11, točke (c) člena 12(1) ter člena 12(2) in (3) Direktive 98/79/EC in obveznosti v zvezi z vigilanco in študijami učinkovitosti, ki so določene v ustreznih prilogah, ki se razveljavijo z učinkom od poznejšega od datumov iz člena 113(2) in točke (f) člena 113(3) te uredbe, in
Evaluation
člena 10 ter točk (a) in (b) člena 12(1) Direktive 98/79/ES in obveznosti v zvezi z registracijo pripomočkov in gospodarskih subjektov ter priglasitvijo certifikatov, ki so določene v ustreznih prilogah, ki se razveljavijo z učinkom 18 mesecev od poznejšega od datumov iz člena 113(2) in točke (f) člena 113(3) te uredbe.
By 27 May 2027, the Commission shall assess the application of this Regulation and produce an evaluation report on the progress towards achievement of the objectives contained herein including an assessment of the resources required to implement this Regulation.
Kar zadeva pripomočke iz člena 110(3) in (4) te uredbe, se Direktiva 98/79/ES še naprej uporablja do 27. maja 2025, in sicer kolikor je potrebno za uporabo navedenih odstavkov.
Special attention shall be given to the traceability of devices through the storage, pursuant to Article 24, of the UDI by economic operators, health institutions and health professionals.
Sklep 2010/227/EU, sprejet za izvajanje direktiv 90/385/EGS, 93/42/EGS in 98/79/ES, se razveljavi z učinkom od poznejšega od datumov iz člena 113(2) in točke (f) člena 113(3) te uredbe.
The evaluation shall also include a review on the functioning of Article 4.
Sklicevanja na razveljavljeno direktivo se razumejo kot sklicevanja na to uredbo in se berejo v skladu s korelacijsko tabelo iz Priloge XV.
Article 112
Člen 113
Repeal
Začetek veljavnosti in datum začetka uporabe
Without prejudice to Articles 110 (3) and (4) of this Regulation, and without prejudice to the obligations of the Member States and manufacturers as regards vigilance and the obligations of manufacturers as regards the making available of documentation, under Directive 98/79/EC, that Directive is repealed with effect from 26 May 2022 with the exception of:
Ta uredba začne veljati dvajseti dan po objavi v Uradnem listu Evropske unije.
Article 11, point (c) of Article 12(1) and Article 12(2) and (3) of Directive 98/79/EC, and the obligations relating to vigilance and performance studies provided for in the corresponding Annexes, which are repealed with effect from the later of the dates referred to in Article 113(2) and point (f) of Article 113(3) of this Regulation; and
Uporablja se od 26. maja 2022.
Article 10 and points (a) and (b) of Article 12(1) of Directive 98/79/EC, and the obligations relating to registration of devices and economic operators, and certificate notifications provided for in the corresponding Annexes, which are repealed with effect from 18 months after the later of the dates referred to in Article 113(2) and point (f) of Article 113(3) of this Regulation.
Z odstopanjem od odstavka 2:
As regards the devices referred to in Article 110(3) and (4) of this Regulation, Directive 98/79/EC shall continue to apply until 27 May 2025 to the extent necessary for the application of those paragraphs.
se člen 27(3) in člen 51(5) uporabljata od 27. novembra 2023;
Decision 2010/227/EU adopted in implementation of Directives 90/385/EEC, 93/42/EEC and 98/79/EC shall be repealed with effect from the later of the dates referred to in Article 113(2) and point (f) of Article 113(3) of this Regulation.
se člen 97 uporablja od 26. maja 2018;
References to the repealed Directive shall be understood as references to this Regulation and shall be read in accordance with the correlation table laid down in Annex XV.
se člen 100 uporablja od 25. novembra 2020;
Article 113
se za pripomočke razreda D člen 24(4) začne uporabljati 26. maja 2023; se za pripomočke razreda B in C člen 24(4) začne uporabljati 26. maja 2025; se za pripomočke razreda A člen 24(4) začne uporabljati 26. maja 2027.
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
Določbe iz prejšnjega stavka so:
It shall apply from 26 May 2022.
člen 26,
By way of derogation from paragraph 2:
člen 28,
Article 27(3) and Article 51(5) shall apply from 27 November 2023;
člen 29,
Articles 31 to 46 and Article 96 shall apply from 26 November 2017.
drugi stavek člena 36(2),
However, from that date until 26 May 2022 the obligations on notified bodies pursuant to Articles 31 to 46 shall apply only to those bodies which submit an application for designation in accordance with Article 34;
člen 38(10),
Article 97 shall apply from 26 May 2018;
člen 39(2),
Article 100 shall apply from 25 November 2020;
drugi pododstavek člena 40(12),
for class D devices, Article 24(4) shall apply from 26 May 2023.
točki (d) in (e) člena 42(7),
For class B and class C devices Article 24(4) shall apply from 26 May 2025.
člen 49(2),
For class A devices Article 24(4) shall apply from 26 May 2027;
člen 50(1),
without prejudice to the obligations on the Commission pursuant to Article 34 of Regulation (EU) 2017/745, where, due to circumstances that could not reasonably have been foreseen when drafting the plan referred to in Article 34(1) of that Regulation, Eudamed is not fully functional on 26 May 2022, the obligations and requirements that relate to Eudamed shall apply from the date corresponding to six months after the date of publication of the notice referred to in Article 34(3) of that Regulation.
členi 66 do 73,
The provisions referred to in the preceding sentence are:
odstavki 1 do 13 člena 74,
Article 26,
členi 75 do 77,
Article 28,
člen 81(2),
Article 29,
člena 82 in 83,
the second sentence of Article 36(2),
člen 84(5) in (7) ter tretji pododstavek člena 84(8),
Article 38(10),
člen 85,
Article 39(2),
člen 88(4), (7) in (8),
the second subparagraph of Article 40(12),
člen 90(2) in (4),
points (d) and (e) of Article 42(7),
zadnji stavek člena 92(2),
Article 49(2),
člen 94(4),
Article 50(1),
drugi stavek prvega pododstavka člena 110(3).
Articles 66 to 73,
Dokler Eudamed ne začne delovati v celoti, se za namene izpolnjevanja obveznosti iz določb, navedenih v prvem odstavku te točke, v zvezi z izmenjavo informacij, predvsem informacij v zvezi s kliničnimi raziskavami, poročanjem o vigilanci, registracijo pripomočkov in gospodarskih subjektov ter priglasitvami certifikatov, še naprej uporabljajo ustrezne določbe iz Direktive 98/79/ES.
paragraphs 1 to 13 of Article 74,
postopek, določen v členu 74, se uporablja od 26. maja 2027, brez poseganja v člen 74(14).
Articles 75 to 77,
člen 110(10) se uporablja od 26. maja 2019.
Article 81(2),
Ta uredba je v celoti zavezujoča in se neposredno uporablja v vseh državah članicah.
Articles 82 and 83,
V Strasbourgu, 5. aprila 2017
Article 84(5) and (7) and the third subparagraph of Article 84(8),
Za Evropski parlament
Article 85,
Predsednik
Article 88(4), (7) and (8),
Za Svet
Article 90(2) and (4),
Mnenje z dne 14. februarja 2013 (UL C 133, 9.5.2013, str.
the last sentence of Article 92(2),
52).
Article 94(4),
Stališče Evropskega parlamenta z dne 2. aprila 2014 (še ni objavljeno v Uradnem listu) in stališče Sveta v prvi obravnavi z dne 7. marca 2017 (še ni objavljeno v Uradnem listu).
the second sentence of the first subparagraph of Article 110(3).
Direktiva 98/79/ES Evropskega parlamenta in Sveta z dne 27. oktobra 1998 o in vitro diagnostičnih medicinskih pripomočkih (UL L 331, 7.12.1998, str.
Until Eudamed is fully functional the corresponding provisions of Directive 98/79/EC shall continue to apply for the purpose of meeting the obligations laid down in the provisions listed in the first paragraph of this point regarding exchange of information including, and in particular, information regarding performance studies, vigilance reporting, registration of devices and economic operators, and certificate notifications.
1).
The procedure set out in Article 74 shall, apply from 26 May 2027 without prejudice to Article 74(14).
Direktiva 2004/30/EU Evropskega parlamenta in Sveta z dne 26. februarja 2014 o harmonizaciji zakonodaj držav članic v zvezi z elektromagnetno združljivostjo (prenovitev) (UL L 96, 29.3.2014, str. 79).
Article 110(10) shall apply from 26 May 2019.
Direktiva Sveta 2013/59/Euratom z dne 5. decembra 2013 o določitvi temeljnih varnostnih standardov za varstvo pred nevarnostmi zaradi ionizirajočega sevanja in o razveljavitvi direktiv 89/618/Euratom, 90/641/Euratom, 96/29/Euratom, 97/43/Euratom in 2003/122/Euratom (UL L 13, 17.1.2014, str.
Opinion of 14 February 2013 (OJ C 133, 9.5.2013, p.
Uredba (ES) št. 765/2008 Evropskega Parlamenta in Sveta z dne 9. julija 2008 o določitvi zahtev za akreditacijo in nadzor trga v zvezi s trženjem proizvodov ter razveljavitvi Uredbe (EGS) št. 339/93 (UL L 218, 13.8.2008, str.
52).
30).
Position of the European Parliament of 2 April 2014 (not yet published in the Official Journal) and position of the Council at first reading of 7 March 2017 (not yet published in the Official Journal).
Sklep št. 768/2008/ES Evropskega parlamenta in Sveta z dne 9. julija 2008 o skupnem okviru za trženje proizvodov in razveljavitvi Sklepa Sveta 93/465/EGS (UL L 218, 13.8.2008, str.
Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices (OJ L 331, 7.12.1998, p.
82).
1).
Direktiva Sveta 85/374/EGS z dne 25. julija 1985 o približevanju zakonov in drugih predpisov držav članic v zvezi z odgovornostjo za proizvode z napako (UL L 210, 7.8.1985, str.
Directive 2014/30/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to electromagnetic compatibility (OJ L 96, 29.3.2014, p.
29).
79).
Sodba z dne 28. julija 2011 v združenih zadevah Orifarm in Paranova, C-400/09 in C-207/10, ECLI:EU:C:2011:519.
Council Directive 2013/59/Euratom of 5 December 2013 laying down basic safety standards for protection against the dangers arising from exposure to ionising radiation, and repealing Directives 89/618/Euratom, 90/641/Euratom, 96/29/Euratom, 97/43/Euratom and 2003/122/Euratom (OJ L 13, 17.1.2014, p.
Uredba (EU) 2017/745 Evropskega parlamenta in Sveta z dne 5. aprila 2017 o medicinskih pripomočkih, spremembi Direktive 2001/83/ES, Uredbe (ES) št. 178/2002 in Uredbe (ES) št. 1223/2009 ter razveljavitvi direktiv Sveta 90/385/EES in 93/42/EES (glej stran 1 tega Uradnega lista).
1).
Sklep Komisije 2010/227/EU z dne 19. aprila 2010 o evropski banki podatkov za medicinske pripomočke (UL L 102, 23.4.2010, str. 45).
Directive (EU) 2015/1535 of the European Parliament and of the Council of 9 September 2015 laying down a procedure for the provision of information in the field of technical regulations and of rules on Information Society services (OJ L 241, 17.9.2015, p.
Direktiva Evropskega parlamenta in Sveta 95/46/ES z dne 24. oktobra 1995 o varstvu posameznikov pri obdelavi osebnih podatkov in o prostem pretoku takih podatkov (UL L 281, 23.11.1995, str.
Regulation (EU) No 1025/2012 of 25 October 2012 of the European Parliament and of the Council on European standardisation, amending Council Directives 89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC, 2007/23/EC, 2009/23/EC and 2009/105/EC of the European Parliament and of the Council and repealing Council Decision 87/95/EEC and Decision No 1673/2006/EC of the European Parliament and of the Council (OJ L 316, 14.11.2012, p.
Uredba (ES) št. 45/2001 Evropskega parlamenta in Sveta z dne 18. decembra 2000 o varstvu posameznikov pri obdelavi osebnih podatkov v institucijah in organih Skupnosti in o prostem pretoku takih podatkov (UL L 8, 12.1.2001, str.
Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 (OJ L 218, 13.8.2008, p. 30).
Direktiva 2010/63/EU Evropskega parlamenta in Sveta z dne 22. septembra 2010 o zaščiti živali, ki se uporabljajo v znanstvene namene (UL L 276, 20.10.2010, str.
Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of products, and repealing Council Decision 93/465/EEC (OJ L 218, 13.8.2008, p.
33).
82).
UL L 123, 12.5.2016, str.
Council Directive 85/374/EEC of 25 July 1985 on the approximation of the laws, regulations and administrative provisions of the Member States concerning liability for defective products (OJ L 210, 7.8.1985, p.
1.
29).
Uredba (EU) št. 182/2011 Evropskega parlamenta in Sveta z dne 16. februarja 2011 o določitvi splošnih pravil in načel, na podlagi katerih države članice nadzirajo izvajanje izvedbenih pooblastil Komisije (UL L 55, 28.2.2011, str.
Judgment of 28 July 2011 in Orifarm and Paranova, joined cases C-400/09 and C-207/10, ECLI:EU:C:2011:519.
13).
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 (see page 1 of this Official Journal).
Direktiva Sveta 90/385/EGS z dne 20. junija 1990 o približevanju zakonodaje držav članic o aktivnih medicinskih pripomočkih za vsaditev (UL L 189, 20.7.1990, str.
Commission Decision 2010/227/EU of 19 April 2010 on the European Databank for Medical Devices (OJ L 102, 23.4.2010, p.
17).
45).
Direktiva Sveta 93/42/EGS z dne 14. junija 1993 o medicinskih pripomočkih (UL L 169, 12.7.1993, str.
31).
UL C 358, 7.12.2013, str.
Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data (OJ L 8, 12.1.2001, p.
10.
1).
Direktiva 2006/42/ES Evropskega parlamenta in Sveta z dne 17. maja 2006 o strojih (UL L 157, 9.6.2006, str.
Directive 2010/63/EU of the European Parliament and the Council of 22 September 2010 on the protection of animals used for scientific purposes (OJ L 276, 20.10.2010. p.
24).
33).
Direktiva 2011/24/EU Evropskega parlamenta in Sveta z dne 9. marca 2011 o uveljavljanju pravic pacientov pri čezmejnem zdravstvenem varstvu (UL L 88, 4.4.2011, str.
OJ L 123, 12.5.2016, p.
45).
1.
Priporočilo Komisije z dne 6. maja 2003 o opredelitvi mikro, malih in srednjih podjetij (UL L 124, 20.5.2003, str.
Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission's exercise of implementing powers (OJ L 55, 28.2.2011, p.
36).
13).
Direktiva 2001/83/ES Evropskega parlamenta in Sveta z dne 6. novembra 2001 o zakoniku Skupnosti o zdravilih za uporabo v humani medicini (UL L 311, 28.11.2001, str.
Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices (OJ L 189, 20.7.1990, p.
67).
17)
Uredba (EU) št. 536/2014 Evropskega parlamenta in Sveta z dne 16. aprila 2014 o kliničnem preskušanju zdravil za uporabo v humani medicini in razveljavitvi Direktive 2001/20/ES (UL L 158, 27.5.2014, str.
Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (OJ L 169, 12.7.1993, p.
1).
1)
PRILOGE
OJ C 358, 7.12.2013, p.
I Splošne zahteve glede varnosti in učinkovitosti
10.
II Tehnična dokumentacija
Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery (OJ L 157, 9.6.2006, p.
III Tehnična dokumentacija o nadzoru po dajanju na trg
24).
IV Izjava EU o skladnosti
Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patients' rights in cross-border healthcare (OJ L 88, 4.4.2011, p.
V Oznaka skladnosti CE
45).
VI Informacije, ki jih je treba predložiti ob registraciji pripomočkov in gospodarskih subjektov v skladu s členoma 26(3) in 28, ter osnovni elementi podatkov, ki jih je treba predložiti za podatkovno zbirko UDI skupaj z UDI-DI v skladu s členoma 25 in 26, in sistem UDI
Commission Recommendation of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises (OJ L 124, 20.5.2003, p.
VII Zahteve, ki jih morajo izpolnjevati priglašeni organi
36).
VIII Pravila za razvrščanje
Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, p.
IX Ugotavljanje skladnosti na podlagi sistema vodenja kakovosti in ocenjevanja tehnične dokumentacije
67).
X Ugotavljanje skladnosti na podlagi pregleda tipa
Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (OJ L 158, 27.5.2014, p.
XI Ugotavljanje skladnosti na podlagi zagotavljanja kakovosti proizvodnje
1).
XII Certifikati, ki jih izda priglašeni organ
ANNEXES
XIII Ocena učinkovitosti, študije učinkovitosti in spremljanje učinkovitosti po dajanju na trg
I General safety and performance requirements
XIV Intervencijske študije klinične učinkovitosti in nekaterih drugih študij učinkovitosti
II Technical documentation
XV Korelacijska tabela
III Technical documentation on post-market surveillance
PRILOGA I
IV EU declaration of conformity
SPLOŠNE ZAHTEVE GLEDE VARNOSTI IN UČINKOVITOSTI
V CE marking of conformity
SPLOŠNE ZAHTEVE
VI Information to be submitted upon the registration of devices and economic operators in accordance with Articles 26(3) and 28, core data elements to be provided to the UDI database together with the UDI-DI in accordance with Articles 25 and 26 and the UDI system
Učinkovitost pripomočkov je takšna, kot so jo predvideli njihovi proizvajalci, pripomočki pa so zasnovani in izdelani tako, da so pri običajnih pogojih uporabe ustrezni za svoj predvideni namen.
VII Requirements to be met by notified bodies
So varni in učinkoviti, ne ogrožajo kliničnega stanja ali varnosti pacientov ali varnosti in zdravja uporabnikov ali, kadar je to ustrezno, drugih oseb, pod pogojem, da so kakršna koli tveganja, ki bi lahko bila povezana z njihovo uporabo, sprejemljiva glede na koristi za pacienta in združljiva z visoko ravnjo varovanja zdravja in varnosti, ob upoštevanju splošno priznanega zadnjega stanja tehničnega razvoja.
VIII Classification rules
Z zahtevo iz te priloge, da se v čim večji možni meri zmanjša tveganje, je mišljeno, da se v čim večji možni meri zmanjša tveganje, ne da bi s tem bistveno poslabšali razmerje med koristmi in tveganji.
IX Conformity assessment based on a quality management system and on assessment of technical documentation
Proizvajalci določijo, izvajajo, dokumentirajo in vzdržujejo sistem obvladovanja tveganj.
X Conformity assessment based on type examination
Obvladovanje tveganj se razume kot neprekinjen in ponavljajoč se proces, ki se izvaja med celotno življenjsko dobo pripomočka in ga je treba redno sistematično posodabljati.
XI Conformity assessment based on production quality assurance
Proizvajalci pri izvajanju obvladovanja tveganj:
XII Certificates issued by a notified body
za vsak pripomoček sestavijo in dokumentirajo načrt za obvladovanje tveganj;
XIII Performance evaluation, performance studies and post-market performance follow-up
opredelijo in analizirajo znane ter predvidljive nevarnosti, povezane s posameznim pripomočkom;
XIV Interventional clinical performance studies and certain other performance studies
ocenijo in ovrednotijo tveganja, povezana s predvideno uporabo ali razumno predvidljivo nepravilno uporabo in se pojavijo med njo;