natgillin/translations-raw huggingface dataset:
Manufacturers shall report any serious incident as referred to in point (a) immediately after they have established a causal relationship between that incident and their device or that such causal relationship is reasonably possible, and not later than 15 days after they become aware of the incident.
Če proizvajalec izve za zaplet, o katerem bi morda bilo treba poročati, vendar ni prepričan, ali bi bilo treba o zapletu poročati, kljub temu predloži poročilo v roku, določenem v odstavkih 2 do 5.
Notwithstanding paragraph 3, in the event of a serious public health threat the report referred to in paragraph 1 shall be provided immediately, and not later than 2 days after the manufacturer becomes aware of that threat.
Razen v nujnih primerih, ko mora proizvajalec takoj sprejeti varnostni korektivni ukrep, proizvajalec nemudoma poroča o varnostnem korektivnem ukrepu iz točke (b) odstavka 1 še pred sprejetjem varnostnega korektivnega ukrepa.
Notwithstanding paragraph 3, in the event of death or an unanticipated serious deterioration in a person's state of health the report shall be provided immediately after the manufacturer has established or as soon as it suspects a causal relationship between the device and the serious incident but not later than 10 days after the date on which the manufacturer becomes aware of the serious incident.
Pri podobnih resnih zapletih, povezanih z istim pripomočkom ali vrsto pripomočka, pri katerih je bil ugotovljen osnovni vzrok ali je bil sprejet varnostni korektivni ukrep, ali kadar se zapleti pojavljajo skupaj in so dobro dokumentirani, lahko proizvajalec namesto posameznih poročil o resnih zapletih predloži redna zbirna poročila, če se je usklajevalni pristojni organ iz člena 84(9) po posvetovanju s pristojnimi organi iz točk (a) in (b) člena 87(8) s proizvajalcem dogovoril glede oblike, vsebine in pogostosti rednih zbirnih poročil.
Where necessary to ensure timely reporting, the manufacturer may submit an initial report that is incomplete followed up by a complete report.
Kadar je pristojni organ iz točk (a) in (b) člena 87(8) en sam, lahko proizvajalec redna zbirna poročila predloži na podlagi sporazuma s tem pristojnim organom.
If, after becoming aware of a potentially reportable incident, the manufacturer is uncertain about whether the incident is reportable, it shall nevertheless submit a report within the timeframe required in accordance with paragraphs 2 to 5.
Države članice sprejmejo ustrezne ukrepe, kot so namenske kampanje obveščanja, za spodbujanje zdravstvenih delavcev, uporabnikov in pacientov, da pristojnim organom poročajo o sumih na resne zaplete iz točke (a) odstavka 1.
Except in cases of urgency in which the manufacturer needs to undertake field safety corrective action immediately, the manufacturer shall, without undue delay, report the field safety corrective action referred to in point (b) of paragraph 1, in advance of the field safety corrective action being undertaken.
Pristojni organi centralno na nacionalni ravni evidentirajo poročila, ki jih prejmejo od zdravstvenih delavcev, uporabnikov in pacientov.
For similar serious incidents that occur with the same device or device type and for which the root cause has been identified or a field safety corrective action implemented or where the incidents are common and well documented, the manufacturer may provide periodic summary reports instead of individual serious incident reports, on condition that the coordinating competent authority referred to in Article 84(9), in consultation with the competent authorities referred to in points (a) and (b) of Article 87(8), has agreed with the manufacturer on the format, content and frequency of the periodic summary reporting.
Pristojni organ države članice v primeru, ko od zdravstvenih delavcev, uporabnikov ali pacientov prejme tako poročilo o sumu na resne zaplete iz točke (a) odstavka 1, sprejme potrebne ukrepe za zagotovitev, da je proizvajalec zadevnega pripomočka nemudoma obveščen o sumu na resni zaplet.
Where a single competent authority is referred to in points (a) and (b) of Article 87(8), the manufacturer may provide periodic summary reports following agreement with that competent authority.
Če proizvajalec zadevnega pripomočka meni, da gre pri zapletu za resni zaplet, potem v skladu z odstavki 1 do 5 tega člena pristojnemu organu države članice, v kateri se je ta resni zaplet pojavil, predloži poročilo o tem resnem zapletu in sprejme ustrezne nadaljnje ukrepe v skladu s členom 84.
The Member States shall take appropriate measures such as organising targeted information campaigns, to encourage and enable healthcare professionals, users and patients to report to the competent authorities suspected serious incidents referred to in point (a) of paragraph 1.
Če proizvajalec zadevnega pripomočka meni, da pri zapletu ne gre za resni zaplet ali da gre za povečanje pričakovanih napačnih rezultatov, ki bo zajeto v poročilu o trendu v skladu s členom 83, potem predloži obrazložitev.
The competent authorities shall record centrally at national level reports they receive from healthcare professionals, users and patients.
Če se pristojni organ ne strinja z ugotovitvijo iz obrazložitve, lahko od proizvajalca zahteva, naj predloži poročilo v skladu z odstavki 1 do 5 tega člena in zagotovi sprejetje ustreznih nadaljnjih ukrepov v skladu s členom 84.
Where a competent authority of a Member State obtains such reports on suspected serious incidents referred to in point (a) of paragraph 1 from healthcare professionals, users or patients, it shall take the necessary steps to ensure that the manufacturer of the device concerned is informed of the suspected serious incident without delay.
Člen 83
Where the manufacturer of the device concerned considers that the incident is a serious incident, it shall provide a report in accordance with paragraphs 1 to 5 of this Article on that serious incident to the competent authority of the Member State in which that serious incident occurred and shall take the appropriate follow-up action in accordance with Article 84.
Poročanje o trendu
Where the manufacturer of the device concerned considers that the incident is not a serious incident or is to be treated as an increase in expected erroneous results, which will be covered by trend reporting in accordance with to Article 83, it shall provide an explanatory statement.
Proizvajalci prek elektronskega sistema iz člena 87 poročajo o vsakem statistično znatnem povečanju pogostosti ali resnosti zapletov, ki niso resni zapleti, ki bi lahko znatno vplivali na analizo koristi in tveganj iz oddelkov 1 in 5 Priloge I ter so privedli ali lahko privedejo do nesprejemljivih tveganj za zdravje ali varnost pacientov, uporabnikov ali drugih oseb, ali o vsakem znatnem povečanju pričakovanih napačnih rezultatov, določenem glede na ugotovljeno učinkovitost pripomočka, kot je navedeno v točkah (a) in (b) oddelka 9.1 Priloge I, in opredeljenem v tehnični dokumentaciji in informacijah o izdelku.
If the competent authority does not agree with the conclusion of the explanatory statement, it may require the manufacturer to provide a report in accordance with paragraphs 1 to 5 of this Article and require it to ensure that appropriate follow-up action is taken in accordance with Article 84.
Proizvajalec v načrtu nadzora po dajanju na trg iz člena 79 določi, kako se odzvati na zaplete iz prvega pododstavka, pa tudi metodologijo, ki se uporablja za ugotavljanje vsakega statistično pomembnega povečanja pogostosti ali resnosti teh dogodkov ali sprememb učinkovitosti, ter trajanje opazovanja.
Article 83
Pristojni organi lahko sami ocenijo poročila o trendih iz odstavka 1 in od proizvajalca zahtevajo, da sprejme ustrezne ukrepe v skladu s to uredbo za zagotovitev varovanja javnega zdravja in varnosti pacientov.
Trend reporting
Vsak pristojni organ obvesti Komisijo, druge pristojne organe in priglašeni organ, ki je izdal certifikat, o rezultatih take ocene in sprejetju takih ukrepov.
Manufacturers shall report by means of the electronic system referred to in Article 87 any statistically significant increase in the frequency or severity of incidents that are not serious incidents that could have a significant impact on the benefit-risk analysis referred to in Sections 1 and 5 of Annex I and which have led or may lead to unacceptable risks to the health or safety of patients, users or other persons or of any significant increase in expected erroneous results established in comparison to the stated performance of the device as referred to in points (a) and (b) of Section 9.1 of Annex I and specified in the technical documentation and product information.
Člen 84
The manufacturer shall specify how to manage the incidents referred to in the first subparagraph and the methodology used for determining any statistically significant increase in the frequency or severity of such events or change in performance, as well as the observation period, in the post-market surveillance plan referred to in Article 79.
Analiza resnih zapletov in varnostni korektivni ukrepi
The competent authorities may conduct their own assessments on the trend reports referred to in paragraph 1 and require the manufacturer to adopt appropriate measures in accordance with this Regulation in order to ensure the protection of public health and patient safety.
Po poročanju o resnem zapletu v skladu s členom 82(1) proizvajalec nemudoma izvede potrebne preiskave v zvezi z resnim zapletom in zadevnimi pripomočki.
Each competent authority shall inform the Commission, the other competent authorities and the notified body that issued the certificate, of the results of such assessment and of the adoption of such measures.
To vključuje oceno tveganja v povezavi z zapletom in varnostne korektivne ukrepe ob upoštevanju meril iz odstavka 3 tega člena, kot je ustrezno.
Article 84
Proizvajalec med preiskavami iz prvega pododstavka sodeluje s pristojnimi organi in po potrebi z zadevnim priglašenim organom in ne izvede nobene raziskave, ki vključuje spremembo pripomočka ali vzorca zadevne serije na način, ki bi lahko vplival na poznejšo oceno vzrokov za zaplet, preden o takšnem ukrepanju obvesti pristojne organe.
Analysis of serious incidents and field safety corrective actions
Države članice sprejmejo potrebne ukrepe za zagotovitev, da njihov pristojni organ po možnosti skupaj s proizvajalcem in po potrebi z zadevnim priglašenim organom koristi in tveganj centralno oceni vse informacije o resnem zapletu, do katerega je prišlo na njihovem ozemlju, ali o varnostnem korektivnem ukrepu, ki je bil ali bo sprejet na njihovem ozemlju in o katerem so bile obveščene v skladu s členom 82.
Following the reporting of a serious incident pursuant to Article 82(1), the manufacturer shall, without delay, perform the necessary investigations in relation to the serious incident and the devices concerned.
V okviru ocene iz odstavka 2 pristojni organ oceni tveganja, ki izhajajo iz sporočenega resnega zapleta, in oceni morebitne varnostne korektivne ukrepe ter pri tem upošteva varovanje javnega zdravja in dejavnike, kot so vzročna povezava, verjetnost odkritja in ponovitve težave, pogostost uporabe pripomočka, verjetnost nastanka neposredne ali posredne škode, resnost te škode, klinična korist pripomočka, ciljni in morebitni uporabniki ter prizadeta populacija.
This shall include risk assessment of the incident and field safety corrective action taking into account the criteria as referred to in paragraph 3 of this Article as appropriate.
Pristojni organ prav tako oceni ustreznost varnostnega korektivnega ukrepa, ki ga je proizvajalec sprejel ali ga namerava sprejeti, in potrebo po kakršnem koli drugem korektivnem ukrepu, pri tem pa zlasti upošteva načelo inherentne varnosti iz Priloge I.
The manufacturer shall co-operate with the competent authorities and where relevant with the notified body concerned during the investigations referred to in the first subparagraph and shall not perform any investigation which involves altering the device or a sample of the batch concerned in a way which may affect any subsequent evaluation of the causes of the incident, prior to informing the competent authorities of such action.
Proizvajalci na zahtevo pristojnega nacionalnega organa predložijo vse dokumente, potrebne za oceno tveganja.
Member States shall take the necessary steps to ensure that any information regarding a serious incident that has occurred within their territory, or a field safety corrective action that has been or is to be undertaken within their territory, and that is brought to their knowledge in accordance with Article 82 is evaluated centrally at national level by their competent authority, if possible together with the manufacturer, and, where relevant, the notified body concerned.
Pristojni organ spremlja preiskavo resnega zapleta, ki jo opravlja proizvajalec.
In the context of the evaluation referred to in paragraph 2, the competent authority shall evaluate the risks arising from the reported serious incident and evaluate any field safety corrective actions, taking into account the protection of public health and criteria such as causality, detectability and probability of recurrence of the problem, frequency of use of the device, probability of occurrence of direct or indirect harm, the severity of that harm, the clinical benefit of the device, intended and potential users, and the population affected.
Pristojni organ lahko po potrebi poseže v preiskavo, ki jo opravlja proizvajalec, ali sproži neodvisno preiskavo.
The competent authority shall also evaluate the adequacy of the field safety corrective action envisaged or undertaken by the manufacturer and the need for, and kind of, any other corrective action, in particular taking into account the principle of inherent safety contained in Annex I.
Proizvajalec prek elektronskega sistema iz člena 87 pristojnemu organu predloži končno poročilo z ugotovitvami iz preiskave.
Upon request by the national competent authority, manufacturers shall provide for all documents necessary for the risk assessment.
Poročilo vsebuje sklepe in po potrebi navaja korektivne ukrepe, ki jih je treba sprejeti.
The competent authority shall monitor the manufacturer's investigation of a serious incident.
V primeru dopolnilne diagnostike ocenjevalni pristojni organ ali usklajevalni pristojni organ iz odstavka 9 tega člena obvesti bodisi ustrezni pristojni organ države članice, ki je odobrila zdravilo, bodisi EMA, kot je ustrezno, odvisno od tega, ali se je priglašeni organ v skladu s postopki iz oddelka 5.2 Priloge IX in oddelka 3.11 Priloge X posvetoval z navedenim nacionalnim pristojnim organom ali EMA.
Where necessary, a competent authority may intervene in a manufacturer's investigation or initiate an independent investigation.
Po izvedbi ocenjevanja v skladu z odstavkom 3 tega člena ocenjevalni pristojni organ prek elektronskega sistema iz člena 87 nemudoma obvesti druge pristojne organe o korektivnih ukrepih, ki jih je proizvajalec sprejel ali jih namerava sprejeti ali so mu bili naloženi za čim večje zmanjšanje tveganja za ponovitev resnega zapleta, vključno z informacijami o povezanem resnem zapletu in rezultatu njegove ocene.
The manufacturer shall provide a final report to the competent authority setting out its findings from the investigation by means of the electronic system referred to in Article 87.
Proizvajalec zagotovi, da so uporabniki zadevnega pripomočka nemudoma obveščeni o sprejetem varnostnem korektivnem ukrepu na podlagi obvestila o varnostnem korektivnem ukrepu.
The report shall set out conclusions and where relevant indicate corrective actions to be taken.
Obvestilo o varnostnem korektivnem ukrepu se pripravi v uradnem jeziku ali jezikih Unije, ki jih določi država članica, v kateri se sprejme varnostni korektivni ukrep.
In the case of companion diagnostic, the evaluating competent authority or the coordinating competent authority referred to in paragraph 9 of this Article shall, depending on whether the relevant competent authority of the Member State that authorised the medicinal products or the EMA was consulted by the notified body in accordance with the procedures set out in Section 5.2 of Annex IX and Section 3.11 of Annex X, inform that national competent authority or the EMA, as appropriate.
Razen v nujnih primerih se vsebina osnutka obvestila o varnostnem korektivnem ukrepu predloži ocenjevalnemu pristojnemu organu ali, v primerih iz odstavka 9, usklajevalnemu pristojnemu organu, da se mu omogoči predložitev pripomb.
After carrying out the evaluation in accordance with paragraph 3 of this Article, the evaluating competent authority shall, through the electronic system referred to in Article 87, inform without delay the other competent authorities of the corrective action taken or envisaged by the manufacturer or required of it to minimise the risk of recurrence of the serious incident, including information on the underlying serious incidents and the outcome of its assessment.
Vsebina obvestila o varnostnem korektivnem ukrepu je enaka v vseh državah članicah, razen če razmere v posamezni državi članici upravičujejo drugačno vsebino.
The manufacturer shall ensure that information about the field safety corrective action taken is brought without delay to the attention of users of the device in question by means of a field safety notice.
Obvestilo o varnostnem korektivnem ukrepu omogoča pravilno identifikacijo zadevnega pripomočka oziroma zadevnih pripomočkov, zlasti z vključitvijo ustreznih UDI ter pravilno identifikacijo proizvajalca, zlasti z vključitvijo njegove enotne registrske številke, če je bila že dodeljena, ki je sprejel varnostni korektivni ukrep.
The field safety notice shall be edited in an official Union language or languages determined by the Member State in which the field safety corrective action is taken.
V obvestilu o varnostnem korektivnem ukrepu so na razumljiv način in brez podcenjevanja ravni tveganja pojasnjeni razlogi za varnostni korektivni ukrep, sprejet zaradi okvare pripomočka in s tem povezanih tveganj za pacienta, uporabnika ali druge osebe, ter jasno navedeni vsi ukrepi, ki jih morajo uporabniki sprejeti.
Except in cases of urgency, the content of the draft field safety notice shall be submitted to the evaluating competent authority or, in the cases referred to in paragraph 9, to the coordinating competent authority to allow them to make comments.
Proizvajalec vnese obvestilo o varnostnem korektivnem ukrepu v elektronski sistem iz člena 87, prek katerega je to obvestilo dostopno javnosti.
Unless duly justified by the situation of the individual Member State, the content of the field safety notice shall be consistent in all Member States.
Pristojni organi v naslednjih primerih dejavno sodelujejo pri postopku, da bi uskladili svoje ocene iz odstavka 3:
The field safety notice shall allow the correct identification of the device or devices involved, in particular by including the relevant UDIs, and the correct identification, in particular by including the SRN, if already issued, of the manufacturer that has undertaken the field safety corrective action.
v primeru zaskrbljenosti glede določenega resnega zapleta ali vrste resnih zapletov v zvezi z istim pripomočkom ali vrsto pripomočka istega proizvajalca v več kot eni državi članici;
The field safety notice shall explain, in a clear manner, without understating the level of risk, the reasons for the field safety corrective action with reference to the device malfunction and associated risks for patients, users or other persons and shall clearly indicate all the actions to be taken by users.
kadar je vprašljiva ustreznost varnostnega korektivnega ukrepa, ki ga predlaga proizvajalec v več kot eni državi članici.
The manufacturer shall enter the field safety notice in the electronic system referred to in Article 87 through which that notice shall be accessible to the public.
Ta usklajeni postopek zajema:
The competent authorities shall actively participate in a procedure in order to coordinate their assessments referred to in paragraph 3 in the following cases:
imenovanje usklajevalnega pristojnega organa za vsak primer posebej, kadar je to potrebno;
where there is concern regarding a particular serious incident or cluster of serious incidents relating to the same device or type of device of the same manufacturer in more than one Member State;
opredelitev usklajenega postopka ocenjevanja, vključno z nalogami in pristojnostmi usklajevalnega pristojnega organa in sodelovanjem drugih pristojnih organov.
where the appropriateness of a field safety corrective action that is proposed by a manufacturer in more than one Member State is in question.
Razen če ni drugače dogovorjeno med pristojnimi organi, se kot usklajevalni pristojni organ imenuje pristojni organ države članice, v kateri ima proizvajalec registrirani kraj poslovanja.
That coordinated procedure shall cover the following:
Usklajevalni pristojni organ prek elektronskega sistema iz člena 87 obvesti proizvajalca, druge pristojne organe in Komisijo, da je prevzel vlogo usklajevalnega organa.
designation of a coordinating competent authority on a case by case basis, when required;
Imenovanje usklajevalnega pristojnega organa ne vpliva na pravice drugih pristojnih organov, da izvedejo lastno oceno in sprejmejo ukrepe v skladu s to uredbo za zagotovitev varovanja javnega zdravja in varnosti pacientov.
defining the coordinated assessment process, including the tasks and responsibilities of the coordinating competent authority and the involvement of other competent authorities.
Usklajevalni pristojni organ in Komisija sta obveščena o rezultatu vsake take ocene in sprejetju takih ukrepov.
Unless otherwise agreed between the competent authorities, the coordinating competent authority shall be the competent authority of the Member State in which the manufacturer has its registered place of business.
Komisija usklajevalnemu pristojnemu organu zagotovi administrativno podporo pri izvajanju njegovih nalog v skladu s tem poglavjem.
The coordinating competent authority shall, through the electronic system referred to in Article 87, inform the manufacturer, the other competent authorities and the Commission that it has assumed the role of coordinating authority.
Člen 85
The designation of a coordinating competent authority shall not affect the rights of the other competent authorities to perform their own assessment and to adopt measures in accordance with this Regulation in order to ensure the protection of public health and patient safety.
Analiza podatkov o vigilanci
The coordinating competent authority and the Commission shall be kept informed of the outcome of any such assessment and the adoption of any such measures.
Komisija v sodelovanju z državami članicami vzpostavi sisteme in postopke za dejavno spremljanje podatkov, ki so na voljo v elektronskem sistemu iz člena 87, da bi se tako določili trendi, vzorci ali zaznali signali v podatkih, ki bi lahko razkrili nova tveganja ali varnostne pomanjkljivosti.
The Commission shall provide administrative support to the coordinating competent authority in the accomplishment of its tasks under this Chapter.
Kadar se ugotovi pred tem še neznano tveganje ali kadar pogostost predvidenega tveganja bistveno in neugodno spremeni določitev koristi in tveganja, pristojni organ ali po potrebi usklajevalni pristojni organ obvesti proizvajalca ali, kadar je to ustrezno, pooblaščenega predstavnika, ki nato sprejme potrebne korektivne ukrepe.
Analysis of vigilance data
Komisija lahko z izvedbenimi akti in po posvetovanju s Koordinacijsko skupino za medicinske pripomočke sprejme podrobne ureditve in postopkovne vidike, potrebne za izvajanje členov 80 do 85 in člena 87, v zvezi z:
The Commission shall, in collaboration with the Member States, put in place systems and processes to actively monitor the data available in the electronic system referred to in Article 87, in order to identify trends, patterns or signals in the data that may reveal new risks or safety concerns.
vrsto resnih zapletov in varnostnimi korektivnimi ukrepi v zvezi s specifičnimi pripomočki oziroma kategorijami ali skupinami pripomočkov;