natgillin/translations-raw huggingface dataset:
Where, within two months of receipt of the notification referred to in Article 95(4), objections are raised by a Member State against a measure taken by another Member State, or where the Commission considers the measure to be contrary to Union law, the Commission shall, after consulting the competent authorities concerned and, where necessary, the economic operators concerned, evaluate that national measure.
Člen 99
On the basis of the results of that evaluation, the Commission may decide, by means of implementing acts, whether or not the national measure is justified.
Dobra upravna praksa
Where the Commission considers the national measure to be justified as referred to in paragraph 1 of this Article, the second subparagraph of Article 95(7) shall apply.
V vseh ukrepih, ki jih sprejmejo pristojni organi držav članic na podlagi členov 95 do 98, se navedejo natančni razlogi za njihovo sprejetje.
If the Commission considers the national measure to be unjustified, the Member State concerned shall withdraw the measure.
Kadar je ukrep naslovljen na določen gospodarski subjekt, pristojni organ nemudoma uradno obvesti zadevni gospodarski subjekt o tem ukrepu ter hkrati seznani zadevni gospodarski subjekt s pravnimi sredstvi, ki so mu na voljo v skladu s pravom ali upravno prakso zadevne države članice, in z roki, ki se za ta pravna sredstva uporabljajo.
Where the Commission does not adopt a decision pursuant to paragraph 1 of this Article within eight months of receipt of the notification referred to in Article 95(4), the national measure shall be considered to be justified.
Če se ukrep splošno uporablja, se ustrezno objavi.
Where a Member State or the Commission considers that the risk to health and safety emanating from a device cannot be mitigated satisfactorily by means of measures taken by the Member State or Member States concerned, the Commission, at the request of a Member State or on its own initiative, may take, by means of implementing acts, the necessary and duly justified measures to ensure the protection of health and safety, including measures restricting or prohibiting the placing on the market and putting into service of the device concerned.
Razen kadar je potrebno takojšnje ukrepanje zaradi nesprejemljivega tveganja za zdravje ali varnost ljudi, se zadevnemu gospodarskemu subjektu zagotovi možnost, da pred sprejetjem kakršnega koli ukrepa svoje pripombe v ustreznem in jasno določenem roku predloži pristojnemu organu.
Article 97
Če je bil ukrep sprejet, ne da bi imel gospodarski subjekt možnost predložitve pripomb v skladu s prvim pododstavkom, se mu omogoči, da pripombe predloži čim prej, sprejeti ukrep pa se nato takoj pregleda.
Other non-compliance
Vsak sprejeti ukrep se takoj prekliče ali spremeni, ko gospodarski subjekt dokaže, da je sprejel učinkovite korektivne ukrepe in da je pripomoček skladen z zahtevami iz te uredbe.
Where, having performed an evaluation pursuant to Article 94, the competent authorities of a Member State find that a device does not comply with the requirements laid down in this Regulation but does not present an unacceptable risk to the health or safety of patients, users or other persons, or to other aspects of the protection of public health, they shall require the relevant economic operator to bring the non-compliance concerned to an end within a reasonable period that is clearly defined and communicated to the economic operator and that is proportionate to the non-compliance.
Kadar ukrep, sprejet na podlagi členov 95 do 98, zadeva pripomoček, pri katerem je v postopku ugotavljanja skladnosti sodeloval priglašeni organ, pristojni organi o sprejetem ukrepu prek elektronskega sistema iz člena 100 obvestijo ustrezni priglašeni organ in organ, pristojen za priglašeni organ.
Where the economic operator does not bring the non-compliance to an end within the period referred to in paragraph 1 of this Article, the Member State concerned shall, without delay, take all appropriate measures to restrict or prohibit the product being made available on the market or to ensure that it is recalled or withdrawn from the market.
Člen 100
That Member State shall inform the Commission and the other Member States, without delay, of those measures, by means of the electronic system referred to in Article 100.
Elektronski sistem za nadzor trga
In order to ensure the uniform application of this Article, the Commission may, by means of implementing acts, specify appropriate measures to be taken by competent authorities to address given types of non-compliance.
Komisija v sodelovanju z državami članicami vzpostavi in upravlja elektronski sistem za zbiranje in obdelavo naslednjih informacij:
Article 98
povzetkov rezultatov dejavnosti nadzora iz člena 93(4);
Preventive health protection measures
končnega poročila o inšpekcijskem pregledu iz člena 93(7);
Where a Member State, after having performed an evaluation which indicates a potential risk related to a device or a specific category or group of devices, considers that, in order to protect the health and safety of patients, users or other persons or other aspects of public health, the making available on the market or putting into service of a device or a specific category or group of devices should be prohibited, restricted or made subject to particular requirements or that such device or category or group of devices should be withdrawn from the market or recalled, it may take any necessary and justified measures.
informacij o pripomočkih, ki pomenijo nesprejemljivo tveganje za zdravje in varnost, kot je navedeno v členu 95(2), (4) in (6);
The Member State referred to in paragraph 1 shall immediately notify the Commission and all other Member States, giving the reasons for its decision, by means of the electronic system referred to in Article 100.
informacij o izdelkih, ki ne izpolnjujejo zahtev, kot je navedeno v členu 97(2);
The Commission, in consultation with the MDCG and, where necessary, the economic operators concerned, shall assess the national measures taken.
informacij o preventivnih ukrepih za varovanje zdravja, kot je navedeno v členu 98(2);
The Commission may decide, by means of implementing acts, whether the national measures are justified or not.
povzetkov rezultatov pregledov in ocen dejavnosti nadzora trga držav članic iz člena 93(8).
In the absence of a Commission decision within six months of their notification, the national measures shall be considered to be justified.
Informacije iz odstavka 1 tega člena se prek elektronskega sistema nemudoma pošljejo vsem zadevnim pristojnim organom in, kadar je ustrezno, priglašenemu organu, ki je izdal certifikat za zadevni pripomoček v skladu s členom 56, in so dostopne državam članicam in Komisiji.
Where the assessment referred to in paragraph 3 of this Article demonstrates that the making available on the market or putting into service of a device, specific category or group of devices should be prohibited, restricted or made subject to particular requirements or that such device or category or group of devices should be withdrawn from the market or recalled in all Member States in order to protect the health and safety of patients, users or other persons or other aspects of public health, the Commission may adopt implementing acts to take the necessary and duly justified measures.
Informacije, ki si jih izmenjajo države članice, se ne objavijo, če bi lahko objava škodila dejavnostim nadzora trga in sodelovanju med državami članicami.
Article 99
POGLAVJE VIII
Good administrative practice
SODELOVANJE MED DRŽAVAMI ČLANICAMI, KOORDINACIJSKA SKUPINA ZA MEDICINSKE PRIPOMOČKE, STROKOVNI LABORATORIJI IN STROKOVNI ODBORI TER REGISTRI PRIPOMOČKOV
Any measure adopted by the competent authorities of the Member States pursuant to Articles 95 to 98 shall state the exact grounds on which it is based.
Člen 101
Where such a measure is addressed to a specific economic operator, the competent authority shall notify without delay the economic operator concerned of that measure, and shall at the same time inform that economic operator of the remedies available under the law or the administrative practice of the Member State concerned and of the time limits to which such remedies are subject.
Pristojni organi
Where the measure is of general applicability, it shall be appropriately published.
Države članice imenujejo pristojni organ ali organe, odgovorne za izvajanje te uredbe.
Except in cases where immediate action is necessary for reasons of unacceptable risk to human health or safety, the economic operator concerned shall be given the opportunity to make submissions to the competent authority within an appropriate period of time that is clearly defined before any measure is adopted.
Zagotovijo jim pooblastila, sredstva, opremo in znanje, ki so potrebni za pravilno izvedbo njihov nalog v skladu s to uredbo.
Where action has been taken without the economic operator having had the opportunity to make submissions as referred to in the first subparagraph, it shall be given the opportunity to make submissions as soon as possible and the action taken shall be reviewed promptly thereafter.
Države članice Komisiji sporočijo nazive in kontaktne podatke pristojnih organov, ki objavi seznam pristojnih organov.
Any measure adopted shall be immediately withdrawn or amended upon the economic operator's demonstrating that it has taken effective corrective action and that the device is in compliance with the requirements of this Regulation.
Člen 102
Where a measure adopted pursuant to Articles 95 to 98 concerns a device for which a notified body has been involved in the conformity assessment, the competent authorities shall by means of the electronic system referred to in Article 100 inform the relevant notified body and the authority responsible for the notified body of the measure taken.
Sodelovanje
Article 100
Pristojni organi držav članic sodelujejo med seboj in s Komisijo.
Electronic system on market surveillance
Komisija organizira izmenjavo informacij, potrebnih za enotno uporabo te uredbe.
The Commission, in collaboration with the Member States, shall set up and manage an electronic system to collate and process the following information:
Države članice ob podpori Komisije po potrebi sodelujejo v mednarodnih pobudah, da se zagotovi sodelovanje med regulativnimi organi na področju medicinskih pripomočkov.
summaries of the results of the surveillance activities referred to in Article 93(4);
Člen 103
the final inspection report referred to in Article 93(7);
Koordinacijska skupina za medicinske pripomočke
information in relation to devices presenting an unacceptable risk to health and safety as referred to in Article 95(2), (4) and (6);
Ustanovi se Koordinacijska skupina za medicinske pripomočke.
information in relation to non-compliance of products as referred to in Article 97(2);
Vsaka država članica za dobo treh let, ki se lahko obnovi, v Koordinacijsko skupino za medicinske pripomočke imenuje enega člana in enega namestnika, ki imata strokovno znanje na področju medicinskih pripomočkov, ter enega člana in enega namestnika, ki imata strokovno znanje na področju in vitro diagnostičnih medicinskih pripomočkov.
information in relation to the preventive health protection measures referred to in Article 98(2);
Država članica lahko imenuje tudi samo enega člana in enega namestnika, ki imata strokovno znanje na obeh področjih.
summaries of the results of the reviews and assessments of the market surveillance activities of the Member States referred to in 93(8).
Člani Koordinacijske skupine za medicinske pripomočke se izberejo na podlagi svoje usposobljenosti in izkušenj na področju medicinskih pripomočkov ter in vitro diagnostičnih medicinskih pripomočkov.
The information referred to in paragraph 1 of this Article shall be immediately transmitted through the electronic system to all competent authorities concerned and, where applicable, to the notified body that issued a certificate in accordance with Article 56 for the device concerned and be accessible to the Member States and to the Commission.
Zastopajo pristojne organe držav članic.
Information exchanged between Member States shall not be made public where to do so might impair market surveillance activities and co-operation between Member States.
Komisija objavi imena članov in organov, ki jih ti člani zastopajo.
CHAPTER VIII
Namestniki nadomeščajo člane in ob njihovi odsotnosti glasujejo namesto njih.
COOPERATION BETWEEN MEMBER STATES, MEDICAL DEVICE COORDINATION GROUP, EXPERT LABORATORIES, EXPERT PANELS AND DEVICE REGISTERS
Koordinacijska skupina za medicinske pripomočke se sestaja redno in po potrebi na zahtevo Komisije ali države članice.
Article 101
Sestankov se udeležijo bodisi člani, imenovani na podlagi njihove vloge in strokovnega znanja v zvezi s področjem medicinskih pripomočkov, bodisi člani, imenovani na podlagi njihovega strokovnega znanja na področju in vitro diagnostičnih medicinskih pripomočkov, bodisi člani, imenovani na podlagi njihovega strokovnega znanja na obeh področjih, ali njihovi namestniki, kakor je primerno.
Competent authorities
Koordinacijska skupina za medicinske pripomočke si po svojih najboljših močeh prizadeva doseči soglasje.
The Member States shall designate the competent authority or authorities responsible for the implementation of this Regulation.
Če takega soglasja ni mogoče doseči, Koordinacijska skupina za medicinske pripomočke odloča z večino svojih članov.
They shall entrust their authorities with the powers, resources, equipment and knowledge necessary for the proper performance of their tasks pursuant to this Regulation.
Člani, katerih stališča se razlikujejo od večinskega stališča, lahko zahtevajo, da se njihova stališča in razlogi zanje zabeležijo v stališču Koordinacijske skupine za medicinske pripomočke.
The Member States shall communicate the names and contact details of the competent authorities to the Commission which shall publish a list of competent authorities.
Koordinacijski skupini za medicinske pripomočke predseduje predstavnik Komisije.
Article 102
Predsedujoči ne sodeluje pri glasovanju v Koordinacijski skupini za medicinske pripomočke.
Cooperation
Koordinacijska skupina za medicinske pripomočke lahko za vsak primer posebej povabi strokovnjake ali druge tretje osebe, da se udeležijo sestankov, ali jih zaprosi, da pripravijo pisne prispevke.
The competent authorities of the Member States shall cooperate with each other and with the Commission.
Koordinacijska skupina za medicinske pripomočke lahko ustanovi stalne ali začasne podskupine.
The Commission shall provide for the organisation of exchanges of information necessary to enable this Regulation to be applied uniformly.
Kadar je to primerno, se organizacije, ki na ravni Unije zastopajo interese industrije medicinskih pripomočkov, zdravstvenih delavcev, laboratorijev, pacientov in potrošnikov, povabijo k sodelovanju v teh podskupinah kot opazovalci.
Member States shall, with the support of the Commission, participate, where appropriate, in initiatives developed at international level with the aim of ensuring cooperation between regulatory authorities in the field of medical devices.
Koordinacijska skupina za medicinske pripomočke sprejme svoj poslovnik, v katerem se določijo zlasti postopki za:
Article 103
sprejetje mnenj ali priporočil ali drugih stališč, tudi v nujnih primerih;
Medical Device Coordination Group
določitev nalog članov poročevalcev in soporočevalcev;
A Medical Device Coordination Group (‘MDCG’) is hereby established.
izvajanje člena 107 v zvezi z nasprotjem interesov;
Each Member State shall appoint to the MDCG, for a three-year term which may be renewed, one member and one alternate each with expertise in the field of medical devices, and one member and one alternate with expertise in the field of in vitro diagnostic medical devices.
delovanje podskupin.
A Member State may choose to appoint only one member and one alternate, each with expertise in both fields.
Koordinacijska skupina za medicinske pripomočke opravlja naloge iz člena 105 te uredbe in člena 99 Uredbe (EU) 2017/746.
The members of the MDCG shall be chosen for their competence and experience in the field of medical devices and in vitro diagnostic medical devices.
Člen 104
They shall represent the competent authorities of the Member States.
Podpora Komisije
The names and affiliation of members shall be made public by the Commission.
Komisija podpira sodelovanje med pristojnimi nacionalnimi organi.
The alternates shall represent and vote for the members in their absence.
Organizira zlasti izmenjavo izkušenj med pristojnimi organi in zagotavlja tehnično, znanstveno in logistično podporo Koordinacijski skupini za medicinske pripomočke in njenim podskupinam.
The MDCG shall meet at regular intervals and, where the situation requires, upon request by the Commission or a Member State.
Organizira sestanke Koordinacijske skupine za medicinske pripomočke in njenih podskupin, sodeluje na navedenih sestankih in zagotavlja ustrezne nadaljnje ukrepe.
The meetings shall be attended either by the members appointed for their role and expertise in the field of medical devices, or by the members appointed for their expertise in the field of in vitro diagnostic medical devices, or by the members appointed for their expertise in both fields, or their alternates, as appropriate.
Člen 105
The MDCG shall use its best endeavours to reach consensus.
Naloge Koordinacijske skupine za medicinske pripomočke
If such consensus cannot be reached, the MDCG shall decide by a majority of its members.
Koordinacijska skupina za medicinske pripomočke v skladu s to uredbo opravlja naslednje naloge:
Members with diverging positions may request that their positions and the grounds on which they are based be recorded in the MDCG's position.
sodeluje pri oceni ustreznosti organov za ugotavljanje skladnosti, ki so vložili vlogo, in priglašenih organov v skladu z določbami, določenimi v poglavju IV;
The MDCG shall be chaired by a representative of the Commission.
svetuje Komisiji na njeno zahtevo v zvezi z zadevami, povezanimi s koordinacijsko skupino priglašenih organov, ustanovljene na podlagi člena 49;
The chair shall not take part in votes of the MDCG.
sodeluje pri razvoju smernic, katerih cilj je zagotoviti učinkovito in usklajeno izvajanje te uredbe, zlasti glede imenovanja in spremljanja priglašenih organov, izpolnjevanja splošnih zahtev glede varnosti in učinkovitosti ter izvedbe kliničnih ocen in raziskav s strani proizvajalcev, ocene s strani priglašenih organov in dejavnosti vigilance;
The MDCG may invite, on a case-by-case basis, experts and other third parties to attend meetings or provide written contributions.
sodeluje pri stalnem spremljanju tehničnega napredka in presoji, ali so splošne zahteve glede varnosti in učinkovitosti, ki jih določata ta uredba in Uredba (EU) 2017/746, ustrezne za zagotovitev varnosti in učinkovitosti pripomočkov, ter tako prispeva k ugotavljanju, ali obstaja potreba po spremembi Priloge I k tej uredbi;
The MDCG may establish standing or temporary sub-groups.
sodeluje pri razvoju standardov za pripomočke, skupnih specifikacij in znanstvenih smernic, vključno s smernicami za posamezni izdelek, za klinične raziskave nekaterih pripomočkov, zlasti pripomočkov za vsaditev in pripomočkov, razvrščenih v razred III;
Where appropriate, organisations representing the interests of the medical device industry, healthcare professionals, laboratories, patients and consumers at Union level shall be invited to such sub-groups in the capacity of observers.
pomaga pristojnim organom držav članic pri njihovih dejavnostih usklajevanja, zlasti na področju razvrstitve in določitve regulativnega statusa pripomočkov, kliničnih raziskav, vigilance in nadzora trga, vključno z razvojem in vzdrževanjem okvira za evropski program za nadzor trga, katerega cilj je zagotoviti učinkovitost in usklajevanje nadzora trga v Uniji v skladu s členom 93;
The MDCG shall establish its rules of procedure which shall, in particular, lay down procedures for the following:
svetuje, bodisi na lastno pobudo ali na zahtevo Komisije, pri oceni katerega koli vprašanja, povezanega z izvajanjem te uredbe;
the adoption of opinions or recommendations or other positions, including in cases of urgency;
sodeluje pri usklajevanju upravne prakse glede pripomočkov v državah članicah.
the delegation of tasks to reporting and co-reporting members;
Člen 106
the implementation of Article 107 regarding conflict of interests;
Zagotavljanje znanstvenega, tehničnega in kliničnega mnenja ter svetovanja
the functioning of sub-groups.
Komisija po posvetovanju s Koordinacijsko skupino za medicinske pripomočke z izvedbenimi akti določi, da se ob upoštevanju načel največje znanstvene usposobljenosti, nepristranskosti, neodvisnosti in preglednosti imenujejo strokovni odbori za vrednotenje klinične ocene na ustreznih medicinskih področjih iz odstavka 9 tega člena in zagotavljanje mnenj v skladu s členom 48(6) Uredbe (EU) 2017/746 o oceni učinkovitosti nekaterih in vitro diagnostičnih medicinskih pripomočkov in po potrebi za kategorije ali skupine pripomočkov ali za posebne nevarnosti, povezane s kategorijo ali skupinami pripomočkov.
The MDCG shall have the tasks laid down in Article 105 of this Regulation and Article 99 of Regulation (EU) 2017/746.
Ista načela se uporabijo, kadar se Komisija odloči za imenovanje strokovnih laboratorijev v skladu z odstavkom 7 tega člena.
Article 104
Strokovni odbori in strokovni laboratoriji se lahko imenujejo na področjih, na katerih je Komisija po posvetovanju s Koordinacijsko skupino za medicinske pripomočke ugotovila potrebo po zagotovitvi usklajenega znanstvenega, tehničnega in/ali kliničnega svetovanja ali laboratorijskega strokovnega znanja v zvezi z izvajanjem te uredbe.
Support by the Commission
Strokovni odbori in strokovni laboratoriji se lahko imenujejo stalno ali začasno.
The Commission shall support the functioning of the cooperation between national competent authorities.
Strokovne odbore sestavljajo svetovalci, ki jih imenuje Komisija na podlagi najnovejših kliničnih, znanstvenih ali tehničnih znanj in izkušenj na določenem področju in z geografsko porazdelitvijo, ki odraža raznolikost znanstvenih in kliničnih pristopov v Uniji.
It shall, in particular, provide for the organisation of exchanges of experience between the competent authorities and provide technical, scientific and logistic support to the MDCG and its sub-groups.
Komisija določi število članov v vsakem odboru v skladu s potrebami.
It shall organise the meetings of the MDCG and its sub-groups, participate in those meetings and ensure the appropriate follow-up.
Člani strokovnih odborov svoje naloge izvajajo nepristransko in objektivno.
Article 105
Ne zahtevajo ali sprejemajo navodil od priglašenih organov ali proizvajalcev.
Tasks of the MDCG
Vsak član predloži izjavo o interesih, ki je dostopna javnosti.
Under this Regulation, the MDCG shall have the following tasks:
Komisija vzpostavi sisteme in postopke za aktivno obvladovanje in preprečevanje morebitnih nasprotij interesov.
to contribute to the assessment of applicant conformity assessment bodies and notified bodies pursuant to the provisions set out in Chapter IV;
Strokovni odbori pri pripravi znanstvenih mnenj upoštevajo relevantne informacije, ki jih predložijo deležniki ter organizacije pacientov in zdravstveni delavci.
to advise the Commission, at its request, in matters concerning the coordination group of notified bodies as established pursuant to Article 49;
Komisija lahko po posvetovanju s Koordinacijsko skupino za medicinske pripomočke ter po objavi razpisa za prijavo interesa v Uradnem listu Evropske unije in na spletnem mestu Komisije imenuje svetovalce za strokovne odbore.
to contribute to the development of guidance aimed at ensuring effective and harmonised implementation of this Regulation, in particular regarding the designation and monitoring of notified bodies, application of the general safety and performance requirements and conduct of clinical evaluations and investigations by manufacturers, assessment by notified bodies and vigilance activities;
Glede na vrsto nalog in potrebo po posebnem strokovnem znanju se lahko svetovalci za strokovne odbore imenujejo za obdobje največ treh let z možnostjo ponovnega imenovanja.