natgillin/translations-raw huggingface dataset:
Done at Brussels, 22 November 2017.
Tai (2,18–35,49 %), Argentina (50,03 USA dollarit / m2), Brasiilia (3,34 USA dollarit / m2 – 6,42 USA dollarit 0 /m2), Lõuna-Korea (9,07–37,40 %), India (kuni 1,87 USA dollarit m2 kohta), Mehhiko (FOB-hinna kohustus mitte vähem kui 6,72 USA dollarit / m2 või tollimaksud 2,9 USA dollarit / m2 – 12,42 USA dollarit / m2) ja Pakistan (5,21–59,18 %).
For the Commission
Allikas: taotluse lisa 22, WTO veebisait lepingu punkti 16.4 kohaste eri riikide poolaasta aruannete kohta ja India rahandusministeeriumi publikatsioon.
The President
Vt komisjoni 16. märtsi 2011. aasta määruse (EL) nr 258/2011 (millega kehtestatakse ajutised dumpinguvastased tollimaksud Hiina Rahvavabariigist pärit keraamiliste plaatide impordi suhtes) (ELT L 70, 17.3.2011, lk 5) põhjendus 78.
OJ L 176, 30.6.2016, p. 21.
I LISA
Council Implementing Regulation (EU) No 917/2011 of 12 September 2011 imposing a definitive anti-dumping duty and collecting definitively the provisional duty imposed on imports of ceramic tiles originating in the People's Republic of China (OJ L 238, 15.9.2011, p. 1), as last amended by Commission Implementing Regulation (EU) 2015/782 of 19 May 2015 adding a company to the list of producers from the People's Republic of China listed in Annex I of Regulation (EU) No 917/2011 (OJ L 124, 20.5.2015, p. 9).
Koostööd tegevad Hiina tootjad, kes ei kuulu valimisse või kelle suhtes ei kohaldata individuaalset kohtlemist:
See Commission Implementing Regulation (EU) 2015/409 of 11 March 2015 amending Council Implementing Regulation (EU) No 917/2011 imposing a definitive anti-dumping duty and collecting definitely the provisional duty imposed on imports of ceramic tiles originating in the People's Republic of China (OJ L 67, 12.3.2015, p. 23).
Nimi
Notice of the impending expiry of certain anti-dumping measures (OJ C 425, 18.12.2015, p. 20).
TARICi lisakood
Notice of initiation of an expiry review of the anti-dumping measures applicable to imports of ceramic tiles originating in the People's Republic of China (OJ C 336, 13.9.2016, p. 5.).
II LISA
Judgment of the Court of 20 March 1985, Case C-264/82 Timex v Council and Commission, ECLI:EU:C:1985:119, at paragraph 24.
Artikli 1 lõikes 3 osutatud kehtival faktuurarvel peab olema faktuurarve väljastanud üksuse töötaja allkirjastatud avaldus järgmises vormis.
Decision of the President of the European Commission of 29 February 2012 on the function and terms of reference of the hearing officer in certain trade proceedings (OJ L 107, 19.4.2012, p. 5).
Faktuurarve väljastanud üksuse töötaja nimi ja ametikoht.
As explained in the recital (10) the names of the Union producers cannot be disclosed for confidentiality reasons.
Järgmine avaldus:
Please refer also to Judgement in Case C-687/13, point 67, request for a preliminary ruling from the Finanzgericht München — Germany, Fliesen-Zentrum Deutschland GmbH v Hauptzollamt Regensburg Fliesen-Zentrum, Judgment of the Court (Third Chamber) of 10 September 2015.
„Mina, allakirjutanu, tõendan, et käesoleva arvega hõlmatud Euroopa Liitu ekspordiks müüdavad keraamilised plaadid (kogus) on valmistanud (äriühingu nimi ja registreeritud asukoht) (TARICi lisakood) (asjaomane riik).
Source: The China Building Ceramics and Sanitary Ware Association (‘CBCSA’) (website: http://www.china-china.cn)
Kinnitan, et käesolevas arves esitatud teave on täielik ja õige.
The actual weights slightly differed from the ones used in the original investigation, established based on data from 2008.
(Kuupäev ja allkiri)“
See recital 121 of the Commission Regulation (EU) No 258/2011 of 16 March 2011 imposing a provisional anti-dumping duty on imports of ceramic tiles originating in the People's Republic of China (OJ L 70, 17.3.2011, p. 5).
Valimisse kaasatud liidu tootjate toodang moodustas üle 8,5 % liidu hinnangulisest kogutoodangust 2015. aastal.
During the original investigation (from 2007 to 31 March 2010), imports from the PRC averaged around 65 million m2 annually.
Esindatud olid äriühingud kõigist kolmest sektorist.
Thailand (2,18-35,49 %), Argentina (USD 50,03/m2), Brazil (USD 3,34/m2 to USD 6,42/m2), South Korea (9,07 % to 37,40 %), India (up to USD 1,87 per m2), Mexico (price commitment FOB no less than USD 6,72/m2, or duties USD 2,9/m2 to USD 12,42/m2), and Pakistan (5,21 %-59,18 %).
Kaks äriühingut olid suurte äriühingute kategooriast, kolm äriühingut olid keskmise suurusega äriühingute kategooriast ja neli äriühingut olid väikeste äriühingute kategooriast.
Source: Annex 22 of the request, WTO website for Semi-annual reports under Article 16.4 of the Agreement from the various countries, and Indian Ministry of Finance publication.
CCCMC vaidlustas võrdlusriigi metoodika normaalväärtuse kui sellise kindlaksmääramisel, väites, et Hiina WTOga ühinemise protokolli 15. jagu on alates 11. detsembrist 2016 aegunud.
See recital 78 of the Commission Regulation (EU) No 258/2011 of 16 March 2011 imposing a provisional anti-dumping duty on imports of ceramic tiles originating in the People's Republic of China (OJ L 70, 17.3.2011, p. 5).
Seega tuleks CCCMC arvates Hiina eksportivate tootjate puhul arvutada normaalväärtus nende enda omamaiste hindade ja/või kulude põhjal.
ANNEX I
Komisjon saatis neile võrdlusriigi küsimustiku 20. jaanuaril 2017. aastal.
Chinese cooperating producers not sampled or not granted individual treatment:
Indiast vastuseid ei saabunud.
Name
Nagu eespool märgitud, andsid endast teada üheksateist Hiina eksportivat tootjat või eksportivate tootjate rühma, kelle tootmisvõimsus moodustas üksnes 1,5 % kogu Hiina hinnangulisest tootmisvõimsusest 2015. aastal.
Taric additional code
Kolme valimisse kaasatud ja nende valdustesse tehtud kontrollkäikude ajal kontrollitud eksportiva tootja tootmisvõimsus moodustas ainult murdosa (nimelt 0,3 %) Hiina hinnangulisest tootmisvõimsusest.
ANNEX II
India keskmised impordihinnad (4,67 eurot/m2) olid läbivaatamisega seotud uurimisperioodil 8 % kõrgemad kui 2013. aasta hinnad.
A declaration signed by an official of the entity issuing the commercial invoice, in the following format, must appear on the valid commercial invoice referred to in Article 1(3):
Kokku langesid kõikide importivate riikide, v.a Hiina RV, impordihinnad vaatlusalusel perioodil 10 % ehk 5,26 eurole/m2.
The name and function of the official of the entity issuing the commercial invoice.
Suhteliselt suurte laovarude (väljendatuna protsendina toodangust) põhjuseks on tarbimise ja seega nõudluse vähenemine viimastel aastatel, pärast 2007. aastat toimunud kriisi ehitussektoris.
The following declaration:
Asjaolu, et keraamilised plaadid on tooted, mis sõltuvad müügi ajal valitsevatest suundumustest, põhjustas äriühingutele lisaraskusi oma varudele nõudluse leidmisel, et sel viisil laovarusid vähendada.
‘I, the undersigned, certify that the (volume) of ceramic tiles sold for export to the European Union covered by this invoice was manufactured by (company name and registered seat) (TARIC additional code) in (country concerned).
Shandong Yadi Ceramics Co.
I declare that the information provided in this invoice is complete and correct.
Ltd.
(Date and signature)’
Hiina metalli-, mineraali- ja kemikaaliimportijate ja -eksportijate kaubanduskoda (The Chinese Chamber of Commerce of Metals, Minerals & Chemicals Importers and Exporters, CCCMC) taotles ärakuulamist.
The sampled Union producers accounted for over 8,5 % of total estimated Union production in 2015.
Läbivaatamisega seotud uurimisperiood
Companies from all of the three sectors were represented: Two companies were from the segment of large companies, three companies were from the segment of medium-sized companies and four companies were from the segment of small companies.
Allikas: kontrollitud vastused küsimustikule
The three Chinese exporting producers sampled and verified during an on-spot verification visit represented a fraction (namely 0,3 %) of the estimated Chinese production.
Ltd.
The relatively high stocks expressed as a percentage of production remains the consequence of the drop of the consumption and thus of the demand in the past years, following the crisis in the construction sector after 2007.
Enping Huiying Ceramics Industry Co.
Jean-Claude Juncker
Ltd.
The drop in consumption after 2007 was caused by a contraction in domestic consumption following the Eurozone crisis and the significant ensuing recession of the construction sector.
Foshan Bailifeng Building Materials Co.
The CCCMC claimed that because of important differences in types of ceramic tiles, there was no competitiverelationship between different types of ceramic tiles, and therefore, prices of one type of ceramic tiles could not exercise pressure on prices of another type of tiles.
Ltd.
It argued that the Commission should have carried out the simulations per product type and not on aggregated basis, as it was the case for the undercutting calculations.
Foshan Bragi Ceramic Co.
Shandong Yadi Ceramics Co Ltd
Ltd.
‘I, the undersigned, certify that the (volume) of ceramic tiles sold for export to the European Union covered by this invoice was manufactured by (company name and registered seat) (TARIC additional code) in (country concerned).
Foshan City Fangyuan Ceramic Co.
The Commission individually examined each of these confidentiality requests for merit thereof.
Foshan Gaoming Shuncheng Ceramic Co.
It established that there was indeed evidence of a significant possibility of retaliation in each case and accepted that the names of these companies should not be disclosed.
Ltd.
The Chinese Chamber of Commerce of Metals, Minerals & Chemicals Importers & Exporters (the ‘CCCMC’) requested a hearing.
Foshan Gaoming Yaju Ceramics Co.
The hearing took place on 6 December 2016.
Ltd.
The limited number of matching product types was explained by the rather complex definition of the product types involving seven characteristics and 672 possible combinations (including, but not limited to, porcelain/non-porcelain, seven types of working surfaces, presence of single/double or no glazing).
Foshan Guanzhu Ceramics Co.
As it is a requirement to take into account 100 % of export sales during dumping calculations, for matching purposes, some adjustments had to be made.
Ltd.
For that reason, the Commission had not performed such a calculation.
Foshan Huashengchang Ceramic Co.
Instead, the Commission duly carried out the undercutting analysis per sampled exporting producer.
Ltd.
The total Union production increased by 10 % in the period considered.
Foshan Jiajun Ceramics Co.
It amounted to 1,24 billion m2 in the RIP.
Ltd.
Second, the Commission looked at price effects.
Foshan Mingzhao Technology Development Co.
It simulated what would be the effect if the entry of low-priced Chinese imports to the Union market would drive down the price of the product concerned, as sold by the Union industry.
Ltd.
RIP Number of employees
Foshan Nanhai Jingye Ceramics Co.
Source: verified questionnaire replies 2013
Ltd.
Dongguan He Mei Ceramics Co.
Foshan Nanhai Shengdige Decoration Material Co.
Dongpeng Ceramic (Qingyuan) Co.
Foshan Nanhai Xiaotang Jinzun Border Factory Co.
Eagle Brand Ceramics Industrial (Heyuan) Co.
Foshan Nanhai Yonghong Ceramic Co.
Enping City Huachang Ceramic Co.
Foshan Oceanland Ceramics Co.
Enping Huiying Ceramics Industry Co.
Foshan Oceano Ceramics Co.
Enping Yungo Ceramic Co.
Foshan Sanshui Hongyuan Ceramics Enterprise Co.
Foshan Aoling Jinggong Ceramics Co.
Foshan Sanshui Huiwanjia Ceramics Co.
Foshan Bailifeng Building Materials Co.
Foshan Sanshui New Pearl Construction Ceramics Industrial Co.
Foshan Bragi Ceramic Co.
Foshan Shiwan Eagle Brand Ceramic Co.
Foshan City Fangyuan Ceramic Co.
Foshan Shiwan Yulong Ceramics Co.
Foshan Gaoming Shuncheng Ceramic Co.
Foshan Summit Ceramics Co.
Foshan Gaoming Yaju Ceramics Co.
Foshan Tidiy Ceramics Co.
Foshan Guanzhu Ceramics Co.
Foshan VIGORBOOM Ceramic Co.
Foshan Huashengchang Ceramic Co.
Foshan Xingtai Ceramics Co.
Foshan Jiajun Ceramics Co.
Foshan Zhuyangyang Ceramics Co.
Foshan Mingzhao Technology Development Co.
Fujian Fuzhou Zhongxin Ceramics Co.
Foshan Nanhai Jingye Ceramics Co.
Fujian Jinjiang Lianxing Building Material Co.
Foshan Nanhai Shengdige Decoration Material Co.
Fujian Minqing Jiali Ceramics Co.
Foshan Nanhai Xiaotang Jinzun Border Factory Co.
Fujian Minqing Ruimei Ceramics Co.
Foshan Nanhai Yonghong Ceramic Co.
Fujian Minqing Shuangxing Ceramics Co.
Foshan Oceanland Ceramics Co.
Gaoyao Yushan Ceramics Industry Co.
Foshan Oceano Ceramics Co.
Guangdong Bode Fine Building Materials Co.
Foshan Sanshui Hongyuan Ceramics Enterprise Co.
Guangdong Foshan Redpearl Building Material Co.
Foshan Sanshui Huiwanjia Ceramics Co.
Guangdong Gold Medal Ceramics Co.
Foshan Sanshui New Pearl Construction Ceramics Industrial Co.
Guangdong Grifine Ceramics Co.
Foshan Shiwan Eagle Brand Ceramic Co.
Guangdong Homeway Ceramics Industry Co.
Foshan Shiwan Yulong Ceramics Co.
Guangdong Huiya Ceramics Co.
Foshan Summit Ceramics Co.
Guangdong Juimsi Ceramics Co.
Foshan Tidiy Ceramics Co.
Guangdong Kaiping Tilee's Building Materials Co.
Foshan VIGORBOOM Ceramic Co.
Guangdong Kingdom Ceramics Co.
Foshan Xingtai Ceramics Co.
Guangdong Monalisa Ceramics Co.
Foshan Zhuyangyang Ceramics Co.
Guangdong New Zhong Yuan Ceramics Co.
Fujian Fuzhou Zhongxin Ceramics Co.
Shunde Yuezhong Branch
Ltd
Guangdong Ouya Ceramics Co.
Fujian Jinjiang Lianxing Building Material Co.
Ltd.
Ltd
Guangdong Overland Ceramics Co.
Fujian Minqing Jiali Ceramics Co.
Ltd.
Ltd
Guangdong Qianghui (QHTC) Ceramics Co.
Fujian Minqing Ruimei Ceramics Co.
Ltd.
Ltd
Guangdong Sihui Kedi Ceramics Co.
Fujian Minqing Shuangxing Ceramics Co.
Ltd.
Ltd
Guangdong Summit Ceramics Co.
Gaoyao Yushan Ceramics Industry Co.
Ltd.
Ltd
Guangdong Tianbi Ceramics Co.
Guangdong Bode Fine Building Materials Co.
Ltd.
Ltd
Guangdong Winto Ceramics Co.
Guangdong Foshan Redpearl Building Material Co.
Ltd.
Ltd
Guangdong Xinghui Ceramics Group Co.
Commission Implementing Regulation (EU) 2017/2183
Komisjoni rakendusmäärus (EL) 2017/2183,
approving non-minor amendments to the specification for a name entered in the register of protected designations of origin and protected geographical indications (‘Arancia del Gargano’ (PGI))
millega kiidetakse heaks oluline muudatus kaitstud päritolunimetuste ja kaitstud geograafiliste tähiste registrisse kantud nimetuse spetsifikaadis „Arancia del Gargano“ (KGT)
Having regard to Regulation (EU) No 1151/2012 of the European Parliament and of the Council of 21 November 2012 on quality schemes for agricultural products and foodstuffs [1], and in particular Article 52(2) thereof,
võttes arvesse Euroopa Parlamendi ja nõukogu 21. novembri 2012. aasta määrust (EL) nr 1151/2012 põllumajandustoodete ja toidu kvaliteedikavade kohta, [1] eriti selle artikli 52 lõiget 2,
Pursuant to the first subparagraph of Article 53(1) of Regulation (EU) No 1151/2012, the Commission examined Italy's application for the approval of amendments to the specification for the protected geographical indication ‘Arancia del Gargano’, registered under Commission Regulation (EC) No 1017/2007 [2].
Vastavalt määruse (EL) nr 1151/2012 artikli 53 lõike 1 esimesele lõigule vaatas komisjon läbi Itaalia taotluse saada heakskiit komisjoni määrusega (EÜ) nr 1017/2007 [2] registreeritud kaitstud geograafilise tähise „Arancia del Gargano“ spetsifikaadi muudatusele.
Since the amendments in question are not minor within the meaning of Article 53(2) of Regulation (EU) No 1151/2012, the Commission published the amendment application in the Official Journal of the European Union [3] as required by Article 50(2)(a) of that Regulation.
Kuna asjaomane muudatus ei ole väike määruse (EL) nr 1151/2012 artikli 53 lõike 2 tähenduses, avaldas komisjon kõnealuse määruse artikli 50 lõike 2 punkti a kohase muutmistaotluse Euroopa Liidu Teatajas [3].
As no statement of opposition under Article 51 of Regulation (EU) No 1151/2012 has been received by the Commission, the amendments to the specification should be approved,
Kuna komisjon ei ole saanud ühtegi määruse (EL) nr 1151/2012 artikli 51 kohast vastuväidet, tuleks spetsifikaadi muudatus heaks kiita,
The amendments to the specification published in the Official Journal of the European Union regarding the name ‘Arancia del Gargano’ (PGI) are hereby approved.
Euroopa Liidu Teatajas avaldatud nimetuse „Arancia del Gargano“ (KGT) spetsifikaadi muudatus kiidetakse heaks.
Commission Regulation (EC) No 1017/2007 of 30 August 2007 entering a designation in the register of protected designations of origin and protected geographical indications (Arancia del Gargano (PGI)) (OJ L 227, 31.8.2007, p. 27).
Komisjoni 30. augusti 2007. aasta määrus (EÜ) nr 1017/2007, millega registreeritakse kaitstud päritolunimetuste ja kaitstud geograafiliste tähiste registris nimetus „Arancia del Gargano“ (KGT) ( ELT L 227, 31.8.2007, lk 27).
OJ C 255, 5.8.2017, p. 19.
ELT C 255, 5.8.2017, lk 19.
Commission Implementing Regulation (EU) 2017/2184
Komisjoni rakendusmäärus (EL) 2017/2184,
Having regard to Reglation (EU) No 1308/2013 of the European Parliament and of the Council of 17 December 2013 establishing a common organisation of the markets in agricultural products and repealing Council Regulations (EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) No 1234/2007 [1], and in particular Article 183(b) thereof,
võttes arvesse Euroopa Parlamendi ja nõukogu 17. detsembri 2013. aasta määrust (EL) nr 1308/2013, millega kehtestatakse põllumajandustoodete ühine turukorraldus ning millega tunnistatakse kehtetuks nõukogu määrused (EMÜ) nr 922/72, (EMÜ) nr 234/79, (EÜ) nr 1037/2001 ja (EÜ) nr 1234/2007, [1] eriti selle artikli 183 punkti b,
Regulation (EC) No 1484/95 should therefore be amended accordingly.
Määrust (EÜ) nr 1484/95 tuleks vastavalt muuta.
Annex I to Regulation (EC) No 1484/95 is replaced by the text set out in the Annex to this Regulation.
Määruse (EÜ) nr 1484/95 I lisa asendatakse käesoleva määruse lisas esitatud tekstiga.
Done at Brussels, 22 November 2017.
Brüssel, 22. november 2017 Komisjoni nimel
OJ L 347, 20.12.2013, p. 671.
ELT L 150, 20.5.2014, lk 1.
ANNEX I
Toote kirjeldus
Description
(eurot / 100 kg)
Representative price
Artiklis 3 osutatud tagatis
Eggs, not in shell, dried
Riikide nomenklatuur on sätestatud komisjoni 27. novembri 2012. aasta määruses (EL) nr 1106/2012, millega rakendatakse Euroopa Parlamendi ja nõukogu määrust (EÜ) nr 471/2009 (mis käsitleb ühenduse statistikat väliskaubanduse kohta kolmandate riikidega) seoses riikide ja territooriumide nomenklatuuri ajakohastamisega (ELT L 328, 28.11.2012, lk 7).
Nomenclature of countries laid down by Commission Regulation (EU) No 1106/2012 of 27 November 2012 implementing Regulation (EC) No 471/2009 of the European Parliament and of the Council on Community statistics relating to external trade with non-member countries, as regards the update of the nomenclature of countries and territories (OJ L 328, 28.11.2012, p. 7).
peadirektor
The code “ZZ” represents “other origins”.
Komisjoni 28. juuni 1995. aasta määrus (EÜ) nr 1484/95, millega sätestatakse täiendavate imporditollimaksude süsteemi üksikasjalikud rakenduseeskirjad ja määratakse kindlaks kodulinnuliha- ja munasektori ning ovoalbumiini kohta täiendavad imporditollimaksud ning tunnistatakse kehtetuks määrus nr 163/67/EMÜ (EÜT L 145, 29.6.1995, lk 47).
Commission Implementing Regulation (EU) 2017/2185
Komisjoni rakendusmäärus (EL) 2017/2185,
of 23 November 2017
23. november 2017,
on the list of codes and corresponding types of devices for the purpose of specifying the scope of the designation as notified bodies in the field of medical devices under Regulation (EU) 2017/745 of the European Parliament and of the Council and in vitro diagnostic medical devices under Regulation (EU) 2017/746 of the European Parliament and of the Council
koodide ja neile vastavate seadmetüüpide loetelu kohta, mida kasutatakse, et täpsustada Euroopa Parlamendi ja nõukogu määruse (EL) 2017/745 kohasteks meditsiiniseadmete valdkonna teavitatud asutusteks ja Euroopa Parlamendi ja nõukogu määruse (EL) 2017/746 kohasteks in vitro diagnostika meditsiiniseadmete valdkonna teavitatud asutusteks määramise kohaldamisala
Having regard to 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 [1], and in particular Articles 39(10) and 42(13) thereof,
Euroopa Parlamendi ja nõukogu 5. aprilli 2017. aasta määrust (EL) 2017/745, milles käsitletakse meditsiiniseadmeid, millega muudetakse direktiivi 2001/83/EÜ, määrust (EÜ) nr 178/2002 ja määrust (EÜ) nr 1223/2009 ning millega tunnistatakse kehtetuks nõukogu direktiivid 90/385/EMÜ ja 93/42/EMÜ, [1] eriti selle artikli 39 lõiget 10 ja artikli 42 lõiget 13,
Having regard to Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU [2], and in particular Articles 35(10) and 38(13) thereof,
Euroopa Parlamendi ja nõukogu 5. aprilli 2017. aasta määrust (EL) 2017/746 in vitro diagnostikameditsiiniseadmete kohta ning millega tunnistatakse kehtetuks direktiiv 98/79/EÜ ja komisjoni otsus 2010/227/EL, [2] eriti selle artikli 35 lõiget 10 ja artikli 38 lõiget 13,
Conformity assessment of medical devices under Regulation (EU) 2017/745 and Regulation (EU) 2017/746 may require involvement of conformity assessment bodies.
Määruse (EL) 2017/745 ja määruse (EL) 2017/746 kohaseks meditsiiniseadmete vastavushindamiseks võib vaja olla kaasata vastavushindamisasutus.
Only conformity assessment bodies that have been designated under Regulation (EU) 2017/745 or Regulation (EU) 2017/746 may carry out such assessment and only for the activities related to the types of devices concerned.
Sellist vastavushindamist võivad teha üksnes määruse (EL) 2017/745 või määruse (EL) 2017/746 alusel määratud vastavushindamisasutused ning hinnata seejuures üksnes asjaomaste meditsiiniseadmetega seotud tegevust.
In order to enable specifying the scope of the designation of conformity assessment bodies notified under Regulation (EU) 2017/745 or Regulation (EU) 2017/746 it is necessary to draw up list of codes and corresponding types of devices.
Et oleks võimalik täpsustada määruse (EL) 2017/745 või määruse (EL) 2017/746 kohaste teavitatud vastavushindamisasutuste määramise kohaldamisala, on vaja koostada koodide ja neile vastavate seadmetüüpide loetelu.
The lists of codes and corresponding types of devices should take into account various device types which can be characterised by design and intended purpose, manufacturing processes and technologies used, such as sterilisation and the use of nanomaterials.
Koodide ja neile vastavate seadmetüüpide loeteludes tuleks arvesse võtta mitmesuguseid seadmetüüpe, mida iseloomustavad nende ehitus või ette nähtud eesmärk, kasutatavad tootmisprotsessid või -tehnoloogia, näiteks sterilisatsioon ja nanomaterjalide kasutamine.
The lists of codes should provide for a multi-dimensional typology of devices which ensures that conformity assessment bodies designated as notified bodies are fully competent for the devices they are required to assess.
Koodide loeteludes tuleks ette näha seadmete mitmekomponendiline tüpoloogia, millega tagatakse, et teavitavateks asutusteks määratud vastavushindamisasutustel on täielik pädevus nende seadmete osas, mille hindamist neilt nõutakse.
In accordance with Article 42(3) of Regulation (EU) 2017/745 and Article 38(3) of Regulation (EU) 2017/746, when notifying the Commission and the other Member States of the conformity assessment bodies they have designated Member States are to clearly specify, using the codes, the scope of the designation indicating the conformity assessment activities and the types of devices which the notified body is authorised to assess.
Vastavalt määruse (EL) 2017/745 artikli 42 lõikele 3 ja määruse (EL) 2017/746 artikli 38 lõikele 3 tuleb liikmesriikidel enda määratud vastavushindamisasutustest komisjonile ja muudele liikmesriikidele teatamisel selgelt ja koode kasutades täpsustada määramise kohaldamisala, nimetades vastavushindamise tegevused ja seadmetüübid, mida teavitatud asutusel on lubatud hinnata.