IN THE CASE OF DEVICES in Slovenian translation

• v primeru pripomočkov
• v primeru priprav

Examples of using In the case of devices in English and their translations into Slovenian

In the case of devices referred to in Annex I, section 7.4, second subparagraph, the scientific opinion of the EMEA must be included in the documentation concerning the device.
V primeru pripomočkov iz tretjega odstavka oddelka 10 Priloge 1 je treba znanstveno mnenje EMEA vključiti v dokumentacijo o pripomočku.

In the case of devices referred to in Annex 1, Section 10a, the scientific opinion of the[Committee of Advanced Therapies] must be included in the documentation concerning the device.
V primeru pripomočkov iz oddelka 10a Priloge 1 je treba znanstveno mnenje[Odbora za napredne terapije] vključiti v dokumentacijo o pripomočku.

(f) In the case of devices placed on the market with a measuring function, a description of the methods used in order to ensure the accuracy as given in the specifications.
(d) v primeru pripomočkov z merilno funkcijo, danih na trg, opis uporabljenih metod, da se zagotovi natančnost, kot je določeno v specifikacijah;

In the case of devices referred to in the second subparagraph of Section 7.4 of Schedule I, the scientific opinion of the EMEA must be included in the documentation concerning the device.
V primeru pripomočkov iz tretjega odstavka oddelka 10 Priloge 1 je treba znanstveno mnenje EMEA vključiti v dokumentacijo o pripomočku.

In the case of devices for performance evaluation, the manufacturer shall follow the procedure referred to in Annex 8 and draw up the statement set out in that Annex before placing such devices on the market.
V primeru pripomočkov za ovrednotenje delovanja proizvajalec ravna po postopku iz Priloge VIII in sestavi izjavo, določeno v tej Prilogi, preden se ti pripomočki dajo na voljo.

(d) in the case of devices for performance evaluation intended to be used in the context of interventional clinical performance studies
Se v primeru pripomočkov za študijo učinkovitosti, ki so namenjeni uporabi v okviru intervencijskih ali drugih študij učinkovitosti,

In the case of devices placed on the market in sterile condition,
V primeru pripomočkov, danih na trg v sterilnem stanju,

In the case of devices referred to in Schedule 1, Section 7.4, second paragraph, the notified body shall, as regards the aspects referred to in that section, consult one of the authorities designated by the Member States in accordance with Directive 2001/83/EC or the EMEA before taking a decision.
V primeru pripomočkov iz drugega odstavka oddelka 10 Priloge 1 se priglašeni organ, v zvezi z vidiki iz tega oddelka, pred odločitvijo posvetuje z enim od pristojnih organov, ki jih določijo države članice v skladu z Direktivo 2001/83/ES, ali EMEA.

4.5 of Annex VIII in the case of devices of classes IIa
v oddelku 3.5 Priloge IX v primeru pripomočkov razredov IIa

In the case of implantable devices and class III devices, clinical investigations shall be performed, except if.
V primeru pripomočkov za vsaditev in pripomočkov razreda III se klinične raziskave opravijo, razen če.

In the case of custom-made devices, the manufacturer shall follow the procedure referred to in Annex VIII and draw up the statement set out in that Annex before placing each device on the market.
V primeru pripomočkov za ovrednotenje delovanja proizvajalec ravna po postopku iz Priloge VIII in sestavi izjavo, določeno v tej Prilogi, preden se ti pripomočki dajo na voljo.

In the case of medical devices, delays in registration of products are another serious concern.
V primeru medicinskih pripomočkov so resna težava tudi zamude pri registraciji proizvodov.

safeguards, and close and lock the doors of the switching devices in case of operating the electrical devices..
namestiti funkcionalne varnostne naprave in varovala, v primeru posega v električne naprave pa mora zapreti in zakleniti vrata stikalnih naprav..

(b) in the case of devices which need to be held with both hands,
(b) v primeru priprav, ki jih je treba držati z obema rokama,

(b) when in the case of devices that must be held with both hands,
(b) v primeru priprav, ki jih je treba držati z obema rokama,

Batch verification in the case of devices incorporating, as an integral part,
Preverjanje serij v primeru pripomočkov, ki vsebujejo zdravilno učinkovino,

In the case of devices placed on the market in a sterile condition,
V primeru pripomočkov, danih na trg v sterilnem stanju,

(c) Moreover, in the case of devices falling into class IIa
(c) Poleg tega revizijski postopek v primeru pripomočkov razreda IIa

(b) In the case of devices containing tissues,
V primeru pripomočkov, ki vsebujejo tkiva,

Batch verification in the case of devices incorporating a medicinal substance which,
Preverjanje serij v primeru pripomočkov, ki vsebujejo zdravilno učinkovino,