natgillin/translations-raw huggingface dataset:
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 89(9), in consultation with the competent authorities referred to in point (a) of Article 92(8), has agreed with the manufacturer on the format, content and frequency of the periodic summary reporting.
Države članice sprejmejo potrebne ukrepe za zagotovitev, da njihov pristojni organ po možnosti skupaj s proizvajalcem in po potrebi z zadevnim priglašenim organom na nacionalni ravni 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 87.
Where a single competent authority is referred to in points (a) and (b) of Article 92(8), the manufacturer may provide periodic summary reports following agreement with that competent authority.
V okviru ocene iz odstavka 2 pristojni organ oceni tveganja, ki izhajajo iz sporočenega resnega zapleta, in oceni morebitne s tem povezane 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.
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.
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 competent authorities shall record centrally at national level reports they receive from healthcare professionals, users and patients.
Proizvajalci na zahtevo pristojnega nacionalnega organa predložijo vse dokumente, potrebne za oceno tveganja.
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.
Pristojni organ spremlja preiskavo resnega zapleta, ki jo opravlja proizvajalec.
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 89.
Pristojni organ lahko po potrebi poseže v preiskavo, ki jo opravlja proizvajalec, ali sproži neodvisno preiskavo.
Where the manufacturer of the device concerned considers that the incident is not a serious incident or is an expected undesirable side-effect, which will be covered by trend reporting in accordance with Article 88, it shall provide an explanatory statement.
Proizvajalec prek elektronskega sistema iz člena 92 pristojnemu organu predloži končno poročilo z ugotovitvami iz preiskave.
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 89.
Poročilo vsebuje sklepe in po potrebi navaja korektivne ukrepe, ki jih je treba sprejeti.
Article 88
Za pripomočke iz prvega pododstavka člena 1(8) in kadar se resni zaplet ali varnostni korektivni ukrep morda nanaša na snov, ki bi se, če bi se uporabljala ločeno, štela za zdravilo, ocenjevalni pristojni organ ali usklajevalni pristojni organ iz odstavka 9 tega člena o tem resnem zapletu ali varnostnem korektivnem ukrepu obvesti bodisi pristojni nacionalni organ bodisi EMA, odvisno od tega, kdo je izdal znanstveno mnenje o tej snovi na podlagi člena 52(9).
Trend reporting
Za pripomočke, ki jih zajema ta uredba v skladu s točko (g) člena 1(6) in kadar se resni zaplet ali varnostni korektivni ukrep morda nanaša na derivate človeških tkiv ali celic, ki se uporabljajo pri proizvodnji pripomočka, ter v primeru pripomočkov, za katere se uporablja ta uredba na podlagi člena 1(10), pristojni organ ali usklajevalni pristojni organ iz odstavka 9 tega člena obvesti pristojni organ za človeška tkiva in celice, s katerim se je posvetoval priglašeni organ v skladu s členom 52(10).
Manufacturers shall report, by means of the electronic system referred to in Article 92, any statistically significant increase in the frequency or severity of incidents that are not serious incidents or that are expected undesirable side-effects 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 risks to the health or safety of patients, users or other persons that are unacceptable when weighed against the intended benefits.
Po izvedbi ocenjevanja v skladu z odstavkom 3 tega člena ocenjevalni pristojni organ prek elektronskega sistema iz člena 92 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 povezanih dogodkih in rezultatu njegove ocene.
The significant increase shall be established in comparison to the foreseeable frequency or severity of such incidents in respect of the device, or category or group of devices, in question during a specific period as specified in the technical documentation and product information.
Proizvajalec zagotovi, da so uporabniki zadevnega pripomočka nemudoma obveščeni o sprejetem varnostnem korektivnem ukrepu na podlagi obvestila o varnostnem korektivnem ukrepu.
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 incidents, as well as the observation period, in the post-market surveillance plan referred to in Article 84.
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.
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.
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.
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.
Vsebina obvestila o varnostnem korektivnem ukrepu je enaka v vseh državah članicah, razen če razmere v posamezni državi članici upravičujejo drugačno vsebino.
Article 89
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.
Analysis of serious incidents and field safety corrective actions
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.
Following the reporting of a serious incident pursuant to Article 87(1), the manufacturer shall, without delay, perform the necessary investigations in relation to the serious incident and the devices concerned.
Proizvajalec vnese obvestilo o varnostnem korektivnem ukrepu v elektronski sistem iz člena 92, prek katerega je to obvestilo dostopno javnosti.
This shall include a risk assessment of the incident and field safety corrective action taking into account criteria as referred to in paragraph 3 of this Article as appropriate.
Pristojni organi v naslednjih primerih dejavno sodelujejo pri postopku, da bi uskladili svoje ocene iz odstavka 3:
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.
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;
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 87 is evaluated centrally at national level by their competent authority, if possible together with the manufacturer, and, where relevant, the notified body concerned.
kadar je vprašljiva ustreznost varnostnega korektivnega ukrepa, ki ga predlaga proizvajalec v več kot eni državi članici.
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 related 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 population affected.
Ta usklajeni postopek zajema:
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.
imenovanje usklajevalnega pristojnega organa za vsak primer posebej, kadar je to potrebno;
Upon request by the national competent authority, manufacturers shall provide all documents necessary for the risk assessment.
opredelitev usklajenega postopka ocenjevanja, vključno z nalogami in pristojnostmi usklajevalnega pristojnega organa in sodelovanjem drugih pristojnih organov.
The competent authority shall monitor the manufacturer's investigation of a serious incident.
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.
Where necessary, a competent authority may intervene in a manufacturer's investigation or initiate an independent investigation.
Usklajevalni pristojni organ prek elektronskega sistema iz člena 92 obvesti proizvajalca, druge pristojne organe in Komisijo, da je prevzel vlogo usklajevalnega organa.
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 92.
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.
The report shall set out conclusions and where relevant indicate corrective actions to be taken.
Usklajevalni pristojni organ in Komisija sta obveščena o rezultatu vsake take ocene in sprejetju takih ukrepov.
In the case of devices referred to in the first subparagraph of Article 1(8) and where the serious incident or field safety corrective action may be related to a substance which, if used separately, would be considered to be a medicinal product, the evaluating competent authority or the coordinating competent authority referred to in paragraph 9 of this Article shall, inform the national competent authority or the EMA, depending on which issued the scientific opinion on that substance under Article 52(9), of that serious incident or field safety corrective action.
Komisija zagotovi administrativno podporo usklajevalnemu pristojnemu organu pri izvajanju njegovih nalog v skladu s tem poglavjem.
In the case of devices covered by this Regulation in accordance with point (g) of Article 1(6) and where the serious incident or field safety corrective action may be related to the derivatives of tissues or cells of human origin utilised for the manufacture of the device, and in the case of devices falling under this Regulation pursuant to Article 1(10), the competent authority or the coordinating competent authority referred to in paragraph 9 of this Article shall inform the competent authority for human tissues and cells that was consulted by the notified body in accordance with Article 52(10).
Člen 90
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 92, 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 events and the outcome of its assessment.
Analiza podatkov o vigilanci
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.
Komisija v sodelovanju z državami članicami vzpostavi sisteme in postopke za dejavno spremljanje podatkov, ki so na voljo v elektronskem sistemu iz člena 92, da bi se tako določili trendi, vzorci ali zaznali signali v podatkih, ki bi lahko razkrili nova tveganja ali varnostne pomanjkljivosti.
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.
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.
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 it to make comments.
Člen 91
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.
Komisija lahko z izvedbenimi akti in po posvetovanju s Koordinacijsko skupino za medicinske pripomočke sprejme podrobne ureditve in postopkovne vidike, potrebne za izvajanje členov 85 do 90 in člena 92, v zvezi z:
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.
vrsto resnih zapletov in varnostnimi korektivnimi ukrepi v zvezi s specifičnimi pripomočki oziroma kategorijami ali skupinami pripomočkov;
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.
poročanjem o resnih zapletih in varnostnih korektivnih ukrepih ter obvestili o varnostnih korektivnih ukrepih in predložitvijo rednih zbirnih poročil, poročil o nadzoru po dajanju na trg, redno posodobljenih poročil o varnosti in poročil o trendih, ki jih proizvajalci predložijo v skladu s členi 85, 86, 87, 88 oziroma 89;
The manufacturer shall enter the field safety notice in the electronic system referred to in Article 92 through which that notice shall be accessible to the public.
standardnimi obrazci za elektronsko in neelektronsko poročanje, vključno z minimalnim sklopom podatkov za poročanje o domnevnih resnih zapletih s strani zdravstvenih delavcev, uporabnikov in pacientov;
The competent authorities shall actively participate in a procedure in order to coordinate their assessments referred to in paragraph 3 in the following cases:
roki za poročanje o varnostnih korektivnih ukrepih ter roki, ki jih morajo proizvajalci upoštevati pri predložitvi rednih zbirnih poročil in poročil o trendih, ob upoštevanju resnosti dogodka, o katerem je treba poročati v skladu s členom 87;
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;
harmoniziranimi obrazci za izmenjavo informacij med pristojnimi organi iz člena 89;
where the appropriateness of a field safety corrective action that is proposed by a manufacturer in more than one Member State is in question.
postopki za določitev usklajevalnega pristojnega organa; usklajenim postopkom ocenjevanja, vključno z nalogami in pristojnostmi usklajevalnega pristojnega organa in sodelovanjem drugih pristojnih organov v tem postopku.
That coordinated procedure shall cover the following:
Člen 92
designation of a coordinating competent authority on a case by case basis, when required;
Elektronski sistem za vigilanco in nadzor po dajanju na trg
defining the coordinated assessment process, including the tasks and responsibilities of the coordinating competent authority and the involvement of other competent authorities.
Komisija v sodelovanju z državami članicami vzpostavi in upravlja elektronski sistem za zbiranje in obdelavo naslednjih informacij:
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.
poročila proizvajalcev o resnih zapletih in varnostnih korektivnih ukrepih iz člena 87(1) in člena 89(5);
The coordinating competent authority shall, through the electronic system referred to in Article 92, inform the manufacturer, the other competent authorities and the Commission that it has assumed the role of coordinating authority.
redna zbirna poročila proizvajalcev iz člena 87(9);
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.
poročila proizvajalcev o trendih iz člena 88;
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.
redno posodobljena poročila o varnosti iz člena 86;
The Commission shall provide administrative support to the coordinating competent authority in the accomplishment of its tasks under this Chapter.
obvestila proizvajalcev o varnostnih korektivnih ukrepih iz člena 89(8);
Article 90
informacije, ki se izmenjujejo med pristojnimi organi držav članic ter med njimi in Komisijo v skladu s členom 89(7) in (9).
Analysis of vigilance data
Ta elektronski sistem vključuje ustrezne povezave do podatkovne zbirke UDI.
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 92, in order to identify trends, patterns or signals in the data that may reveal new risks or safety concerns.
Pristojni organi držav članic in Komisija imajo prek elektronskega sistema dostop do informacij iz odstavka 1 tega člena.
Where a previously unknown risk is identified or the frequency of an anticipated risk significantly and adversely changes the benefit-risk determination, the competent authority or, where appropriate, the coordinating competent authority shall inform the manufacturer, or where applicable the authorised representative, which shall then take the necessary corrective actions.
Do njih imajo dostop tudi priglašeni organi, kolikor se te informacije nanašajo na pripomočke, za katere so v skladu s členom 53 izdali certifikat.
Article 91
Komisija zagotovi, da imajo zdravstveni delavci in javnost ustrezno raven dostopa do elektronskega sistema iz odstavka 1.
The Commission may, by means of implementing acts, and after consultation of the MDCG, adopt the detailed arrangements and procedural aspects necessary for the implementation of Articles 85 to 90 and 92 as regards the following:
Komisija lahko pristojnim organom tretjih držav ali mednarodnim organizacijam na podlagi sporazumov z njimi odobri ustrezno raven dostopa do elektronskega sistema iz odstavka 1.
the typology of serious incidents and field safety corrective actions in relation to specific devices, or categories or groups of devices;
Navedeni sporazumi temeljijo na vzajemnosti ter zagotavljajo isto raven zaupnosti in varstva podatkov, kot se zahteva v Uniji.
the reporting of serious incidents and field safety corrective actions and field safety notices, and the provision of periodic summary reports, post-market surveillance reports, PSURs and trend reports by manufacturers as referred to in Articles 85, 86, 87, 88 and 89 respectively;
Poročila o resnih zapletih iz točke (a) člena 87(1) se po prejemu samodejno posredujejo prek elektronskega sistema iz odstavka 1 tega člena pristojnemu organu države članice, v kateri se je zaplet zgodil.
standard structured forms for electronic and non-electronic reporting, including a minimum data set for reporting of suspected serious incidents by healthcare professionals, users and patients;
Poročila o trendih iz člena 88(1) se po prejemu samodejno posredujejo prek elektronskega sistema iz odstavka 1 tega člena pristojnim organom države članice, v kateri so se zapleti zgodili.
timelines for the reporting of field safety corrective actions, and for the provision by manufacturers of periodic summary reports and trend reports, taking into account the severity of the incident to be reported as referred to in Article 87;
Poročila o varnostnih korektivnih ukrepih iz točke (b) člena 87(1) se po prejemu samodejno posredujejo prek elektronskega sistema iz odstavka 1 tega člena pristojnim organom naslednjih držav članic:
harmonised forms for the exchange of information between competent authorities as referred to in Article 89;
držav članic, v katerih se sprejema ali bo sprejet varnostni korektivni ukrep;