FrancophonIA/Publications_Medical_Domain_UE huggingface dataset:
English: (4) Under Article 8(2) read in conjunction with Article 10(2) of Council Regulation (EEC) No 95/93, the failure by an air carrier to operate 80% of a series of slots which it has been allocated at a coordinated airport threatens the historic precedence for these slots.
Danish: (4) I henhold til artikel 8, stk. 2, sammenholdt med artikel 10, stk. 2, i Rådets forordning (EØF) nr. 95/93, trues et luftfartsselskabs hævdvundne rettigheder til de pågældende slots, hvis det ikke benytter mindst 80 % af en given slotserie, der er blevet tildelt det ved en koordineret lufthavn.
English: However, under the slots regulation, in order to guarantee allocation of the same slots in respect of the same season the following year, air carriers are obliged to use slots at least 80% of the time over the scheduling period for which they have been allocated.
Danish: I henhold til forordningen om lufthavnsslots er luftfartsselskaberne imidlertid forpligtet til at anvende slots mindst 80 % af tiden i løbet den fartplansæson, for hvilken de er blevet tildelt, for at være sikret tildelingen af samme slots for samme sæson i det efterfølgende år.
English: Returned slots which are subsequently reallocated to other air carriers would not be eligible for grandfathering for the air carrier operating them.
Danish: Hvis de returnerede slots efterfølgende omfordeles til andre luftfartsselskaber, og disse luftfartsselskaber benytter dem, vil de pågældende luftfartsselskaber ikke opnå hævdvundne rettigheder til disse slots.
English: The proposal does not have a budgetary impact for the EU institutions.
Danish: Forslaget har ingen budgetmæssige virkninger for EU-institutionerne.
English: In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives.
Danish: I overensstemmelse med proportionalitetsprincippet, jf. nævnte artikel, går denne forordning ikke videre, end hvad der er nødvendigt for at nå disse mål.
English: In this regard, the legislation, that is being amended, is adopted in full compliance with the principle of subsidiarity and any amendment thereto must be made through a Commission proposal.
Danish: I denne henseende er den lovgivning, der ændres, vedtaget i fuld overensstemmelse med nærhedsprincippet, og eventuelle ændringer heraf skal ske via et forslag fra Kommissionen.
English: According to the principle of subsidiarity, Union action may only be taken if the envisaged aims cannot be achieved by Member States alone.
Danish: I overensstemmelse med nærhedsprincippet må der kun handles på EU-plan, hvis de forventede mål ikke kan opfyldes af medlemsstaterne alene.
English: It was therefore considered to be appropriate to provide for an exception to the eight-week period referred to in Article 4 of Protocol No 1 on the role of national Parliaments in the European Union, annexed to the Treaty on European Union, to the Treaty on the Functioning of the European Union and to the Treaty establishing the European Atomic Energy Community.
Danish: Det blev derfor anset for hensigtsmæssigt at gøre en undtagelse fra den periode på otte uger, der er omhandlet i artikel 4 i protokol nr. 1 om de nationale parlamenters rolle i Den Europæiske Union, der er knyttet som bilag til traktaten om Den Europæiske Union, til traktaten om Den Europæiske Unions funktionsmåde og til traktaten om oprettelse af Det Europæiske Atomenergifællesskab.
English: Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 and Article 168(4)(c) thereof,
Danish: under henvisning til traktaten om Den Europæiske Unions funktionsmåde, særlig artikel 114 og artikel 168, stk. 4, litra c),
English: "(j) Article 59 shall apply from [insert date - date of entry into force of this Regulation]';
Danish: "j) artikel 59 anvendes fra den [indsæt dato - datoen for denne forordnings ikrafttræden]."
English: Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 114(3).
Danish: Disse gennemførelsesretsakter vedtages efter undersøgelsesproceduren i artikel 114, stk.
English: ‘(g) with regard to reusable devices that are required to bear the UDI carrier on the device itself, Article 27(4) shall apply to:
Danish: "g) for genanvendeligt udstyr, der skal være forsynet med UDI-bæreren på selve udstyret, finder artikel 27, stk. 4, anvendelse på:
English: Those deferrals safeguard the presence of a functioning regulatory framework on medical devices from 26 May 2020.
Danish: Disse udskydelser sikrer, at der fra den 26. maj 2020 findes en velfungerende lovramme for medicinsk udstyr.
English: This proposal is not accompanied by a separate impact assessment, as an impact assessment for Regulation (EU) 2017/745 has already been undertaken.
Danish: Dette forslag ledsages ikke af en særskilt konsekvensanalyse, da der allerede er blevet foretaget en konsekvensanalyse i forbindelse med forordning (EU) 2017/745.
English: (12) The adoption of this Regulation takes place under exceptional circumstances arising from the COVID-19 outbreak and the associated public health crisis.
Danish: (12) Vedtagelsen af denne forordning finder sted under ekstraordinære omstændigheder som følge af covid-19-udbruddet og den dermed forbundne folkesundhedskrise.
English: Reasons for and objectives of the proposal
Danish: Forslagets begrundelse og formål
English: This proposal does not alter Regulation (EU) 2017/745 on substance and does not impose new obligations on the concerned parties.
Danish: Dette forslag indebærer ikke en indholdsmæssig ændring af forordning (EU) 2017/745 og pålægger ikke de berørte parter nye forpligtelser.
English: (13) In light of the overriding need to immediately address the public health crisis associated with the COVID-19 outbreak, this Regulation should enter into force as a matter of urgency,
Danish: (13) I lyset af det tvingende behov for straks at imødegå den folkesundhedskrise, der er forbundet med covid-19-udbruddet, bør denne forordning træde i kraft så hurtigt som muligt -
English: After consulting the European Economic and Social Committee,
Danish: efter høring af Det Europæiske Økonomiske og Sociale Udvalg,
English: Regulation (EU) 2017/745 also allows the Commission to extend, in exceptional cases, the validity of a national derogation for a limited period of time to the territory of the Union (‘Union-wide derogation').
Danish: Forordning (EU) 2017/745 giver også Kommissionen mulighed for i undtagelsestilfælde at udvide gyldigheden af en national undtagelse i en begrænset periode til Unionens område ("EU-dækkende undtagelse").
English: Subsidiarity
Danish: Nærhedsprincippet
English: amending Regulation (EU) 2017/745 on medical devices as regards the dates of application of certain of its provisions
Danish: om ændring af forordning (EU) 2017/745 om medicinsk udstyr for så vidt angår datoerne for anvendelse af visse af dens bestemmelser
English: The proposal is based on Articles 114 and 168(4)(c) of the Treaty on the Functioning of the European Union (TFEU).
Danish: Retsgrundlaget for dette forslag er artikel 114 og artikel 168, stk. 4, litra c), i traktaten om Den Europæiske Unions funktionsmåde (TEUF).
English: After consulting the Committee of the Regions,
Danish: efter høring af Regionsudvalget,
English: Proportionality
Danish: Proportionalitetsprincippet
English: (3) Medical devices, such as medical gloves, surgical masks, equipment for intensive care and other medical equipment, play a crucial role in the context of the COVID-19 outbreak and the associated public health crisis to ensure the health and safety of Union citizens and to enable Member States to give patients urgently in need the necessary medical treatment.
Danish: (3) Medicinsk udstyr, såsom handsker til medicinsk brug, operationsmasker, udstyr til intensiv behandling og andet medicinsk udstyr, spiller en afgørende rolle i forbindelse med covid-19-udbruddet og den dermed forbundne folkesundhedskrise med henblik på at sikre EU-borgernes sundhed og sikkerhed og sætte medlemsstaterne i stand til hurtigt at give patienterne den nødvendige lægebehandling.
English: This Union action is necessary to achieve the objective of the proper implementation and application of Regulation (EU) 2017/745 by all involved parties, taking into account the magnitude of the current COVID-19 outbreak and the associated public health crisis.
Danish: Denne EU-foranstaltning er nødvendig for at nå målet om en korrekt gennemførelse og anvendelse af forordning (EU) 2017/745 blandt alle involverede parter under hensyntagen til omfanget af det nuværende covid-19-udbrud og den dermed forbundne folkesundhedskrise.
English: In addition, the proposed amendment seeks to ensure that the Commission is able to adopt, in exceptional cases, Union-wide derogations in response to national derogations at the earliest date possible in order to address potential shortages Union wide of vitally important medical devices in an effective manner.
Danish: Formålet med den foreslåede ændring er desuden at sikre, at Kommissionen i ekstraordinære tilfælde er i stand til at vedtage EU-dækkende undtagelser som reaktion på nationale undtagelser så hurtigt som muligt for at imødegå potentielle mangler på livsvigtigt medicinsk udstyr på EU-plan på en effektiv måde.
English: (10) Regulation (EU) 2017/745 should therefore be amended accordingly.
Danish: (10) Forordning (EU) 2017/745 bør derfor ændres.
English: [1: 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 (OJ L 117, 5.5.2017, p.
Danish: [1: Europa-Parlamentets og Rådets forordning (EU) 2017/745 af 5. april 2017 om medicinsk udstyr, om ændring af direktiv 2001/83/EF, forordning (EF) nr. 178/2002 og forordning (EF) nr. 1223/2009 og om ophævelse af Rådets direktiv 90/385/EØF og 93/42/EØF (EUT L 117 af 5.5.2017, s.
English: To attain the intended effect of amending Regulation (EU) 2017/745 as regards the dates of application of certain provisions, it is necessary for this Regulation to enter into force before 26 May 2020.
Danish: For at opnå den ønskede virkning af at ændre forordning (EU) 2017/745 for så vidt angår datoerne for anvendelse af visse bestemmelser er det nødvendigt, at denne forordning træder i kraft inden den 26. maj 2020.
English: Union intervention is required to ensure a high level of protection of health for patients and users, the smooth functioning of the internal market and avoid potential market disruption.
Danish: Der er behov for en EU-indsats for at sikre et højt sundhedsbeskyttelsesniveau for patienter og brugere og et velfungerende indre marked og undgå markedsforstyrrelser.
English: The COVID-19 crisis has created extraordinary circumstances that demand substantial additional resources, as well as an increased availability of vitally important medical devices, that could not reasonably have been anticipated at the time of adoption of Regulation (EU) 2017/745.
Danish: Covid-19-krisen har skabt ekstraordinære omstændigheder, som kræver betydelige ekstra ressourcer samt en øget tilgængelighed af livsvigtig medicinsk udstyr, som ikke med rimelighed kunne have været forudset på tidspunktet for vedtagelsen af forordning (EU) 2017/745.
English: At the same time, it is necessary to defer the date of repeal of Directives 90/385/EEC and 93/42/EEC.
Danish: Samtidig er det nødvendigt at udskyde datoen for ophævelse af direktiv 90/385/EØF og 93/42/EØF.
English: Taking into account the COVID-19 outbreak and the associated public health crisis, the Commission should be able to adopt Union-wide derogations in response to national derogations in order to address potential shortages Union wide of vitally important medical devices in an effective manner.
Danish: Under hensyntagen til covid-19-udbruddet og den dermed forbundne folkesundhedskrise bør Kommissionen være i stand til at vedtage EU-dækkende undtagelser som reaktion på nationale undtagelser for at imødegå potentielle mangler på livsvigtigt medicinsk udstyr på EU-plan på en effektiv måde.
English: (9) To ensure the continuous presence of a functioning and effective regulatory framework for medical devices it is necessary to also defer the application of the provision repealing Directives 90/385/EEC and 93/42/EEC.
Danish: (9) For at sikre, at der til stadighed findes et velfungerende og effektivt regelsæt for medicinsk udstyr, er det nødvendigt også at udskyde anvendelsen af bestemmelsen om ophævelse af direktiv 90/385/EØF og 93/42/EØF.
English: Regulation (EU) 2017/745 is amended as follows:
Danish: I forordning (EU) 2017/745 foretages følgende ændringer:
English: ][3: Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (OJ L 169, 12.7.1993, p.
Danish: ][3: Rådets direktiv 93/42/EØF af 14. juni 1993 om medicinsk udstyr (EFT L 169 af 12.7.1993, s.
English: In order to take account of the fact that the possibility to adopt Union-wide derogations must, for a transitional period, be given to the Commission in relation to national derogations from Directives 90/385/EEC and 93/42/EEC, certain amendments to the relevant provisions of Regulation (EU) 2017/745 are necessary.
Danish: For at tage hensyn til det forhold, at muligheden for at vedtage EU-dækkende undtagelser i en overgangsperiode skal gives til Kommissionen i tilknytning til nationale undtagelser fra direktiv 90/385/EØF og 93/42/EØF, er det nødvendigt at foretage visse ændringer af de relevante bestemmelser i forordning (EU) 2017/745.
English: Devices lawfully placed on the market pursuant to Directives 90/385/EEC and 93/42/EEC prior to 26 May 2021, and devices placed on the market from 26 May 2021 pursuant to paragraph 3 of this Article, may continue to be made available on the market or put into service until 26 May 2025.
Danish: Udstyr, der lovligt er bragt i omsætning i henhold til direktiv 90/385/EØF og 93/42/EØF før den 26. maj 2021, og udstyr, der er bragt i omsætning fra den 26. maj 2021, i henhold til denne artikels stk. 3, kan fortsat gøres tilgængeligt på markedet eller ibrugtages indtil den 26. maj 2025."
English: At the same time, Regulation (EU) 2017/745 sets high standards of quality and safety for medical devices in order to meet common safety concerns as regards such devices.
Danish: Forordning (EU) 2017/745 fastsætter samtidig høje standarder for medicinsk udstyrs kvalitet og sikkerhed for at imødegå fælles sikkerhedsbekymringer for så vidt angår sådant udstyr.
English: Regulation (EU) 2017/745 significantly reinforces key elements of the existing regulatory approach in Council Directive 90/385/EEC and Council Directive 93/42/EEC, such as the supervision of notified bodies, conformity assessment procedures, clinical investigations and clinical evaluation, vigilance and market surveillance, whilst introducing provisions ensuring transparency and traceability regarding medical devices, to improve health and safety.
Danish: Forordning (EU) 2017/745 styrker i væsentlig grad centrale elementer i den eksisterende reguleringstilgang i Rådets direktiv 90/385/EØF og Rådets direktiv 93/42/EØF, som f.eks. overvågning af bemyndigede organer, overensstemmelsesvurderingsprocedurer, kliniske afprøvninger og klinisk evaluering, sikkerhedsovervågning og markedsovervågning, samtidig med at der indføres bestemmelser, der sikrer gennemsigtighed og sporbarhed i forbindelse med medicinsk udstyr for at forbedre sundheden og sikkerheden.
English: ][2: Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices (OJ L 189, 20.7.1990, p.
Danish: ][2: Rådets direktiv 90/385/EØF af 20. juni 1990 om indbyrdes tilnærmelse af medlemsstaternes lovgivning om aktivt, implantabelt medicinsk udstyr (EFT L 189 af 20.7.1990, s.
English: (8) In order to cover any national derogations granted by the Member States in accordance with Directives 90/385/EEC or 93/42/EEC in the context of the COVID-19 outbreak before the entry into force of this Regulation, it is also necessary to provide for the possibility for the Member States to notify those national derogations and for the Commission to extend their validity to the territory of the Union.
Danish: (8) For at dække nationale undtagelser, der er givet af medlemsstaterne i henhold til direktiv 90/385/EØF eller 93/42/EØF i forbindelse med covid-19-udbruddet før denne forordnings ikrafttræden, er det også nødvendigt at give medlemsstaterne mulighed for at give meddelelse om disse nationale undtagelser og give Kommissionen mulighed for at udvide deres gyldighed til Unionens område.
English: Those extraordinary circumstances have a significant impact on various areas covered by Regulation (EU) 2017/745, such as the designation and work of notified bodies and the placing on the market and making available on the market of medical devices in the Union.
Danish: Disse ekstraordinære omstændigheder har betydelige konsekvenser for forskellige områder, der er omfattet af forordning (EU) 2017/745, såsom udpegelse af bemyndigede organer og deres arbejde samt omsætning og tilgængeliggørelse på markedet af medicinsk udstyr i Unionen.
English: It is for this reason appropriate that the relevant provision of Regulation (EU) 2017/745 applies at the earliest date possible and that the corresponding provisions of Directives 90/385/EEC and 93/42/EEC are repealed from that same date.
Danish: Den relevante bestemmelse i forordning (EU) 2017/745 bør derfor finde anvendelse hurtigst muligt, og de tilsvarende bestemmelser i direktiv 90/385/EØF og 93/42/EØF bør ophæves fra samme dato.
English: "- Article 11(13) of Directive 93/42/EEC and Article 9(9) of Directive 90/385/EEC which are repealed with effect from [insert date - date of entry into force of this Regulation]";
Danish: "- artikel 11, stk. 13, i direktiv 93/42/EØF og artikel 9, stk. 9, i direktiv 90/385/EØF, som ophæves med virkning fra den [indsæt dato - datoen for denne forordnings ikrafttræden]."
English: The proposed amendment aims to ensure that the intended purpose of Regulation (EU) 2017/745, that is, to establish a robust, transparent, predictable and sustainable regulatory framework for medical devices, which guarantees a high level of protection of public health and patient safety and the smooth functioning of the internal market for such devices, can be attained.
Danish: Den foreslåede ændring har til formål at sikre, at formålet med forordning (EU) 2017/745, dvs. at etablere et robust, gennemsigtigt, forudsigeligt og bæredygtigt regelsæt for medicinsk udstyr, som sikrer et højt niveau for beskyttelse af folkesundheden og patientsikkerheden samt et velfungerende indre marked for medicinsk udstyr, kan nås.
English: To ensure the continuous availability of medical devices on the Union market, including medical devices that are vitally important in the context of the COVID-19 outbreak and the associated public health crisis, it is also necessary to adapt certain transitional provisions of Regulation (EU) 2017/745 that would otherwise no longer apply as from the date of application of those provisions.
Danish: For at sikre, at der til stadighed er medicinsk udstyr til rådighed på EU-markedet, herunder medicinsk udstyr, der er af livsvigtig betydning i forbindelse med covid-19-udbruddet og den dermed forbundne folkesundhedskrise, er det også nødvendigt at tilpasse visse overgangsbestemmelser i forordning (EU) 2017/745, som ellers ikke længere ville finde anvendelse fra datoen for anvendelse af bestemmelserne.
English: EN 7 EN
Danish: DA 7 DA
English: (11) Since the objectives of this Regulation, namely to defer the application of certain provisions of Regulation (EU) 2017/745 and to allow for the extension of the validity of national derogations, authorised under Directives 90/385/EEC or 93/42/EEC, to the territory of the Union, cannot be sufficiently achieved by the Member States but can rather, by reason of its scale and effects, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union.
Danish: (11) Målene for denne forordning, nemlig at udskyde anvendelsen af visse bestemmelser i forordning (EU) 2017/745 og tillade udvidelse af gyldigheden af nationale undtagelser, der er tilladt i henhold til direktiv 90/385/EØF eller 93/42/EØF, til hele Unionens område, kan ikke i tilstrækkelig grad opfyldes af medlemsstaterne, men kan på grund af foranstaltningens omfang og virkninger bedre nås på EU-plan; Unionen kan derfor vedtage foranstaltninger i overensstemmelse med nærhedsprincippet, jf. artikel 5 i traktaten om Den Europæiske Union.
English: Taking into account the COVID-19 outbreak and the associated public health crisis, its epidemiological development, as well as the additional resources required in the Member States, health institutions, economic operators and other relevant parties, it is appropriate to defer the application of the relevant provisions of Regulation (EU) 2017/745 by one year.
Danish: Under hensyntagen til covid-19-udbruddet og den dermed forbundne folkesundhedskrise, sygdommen epidemiologiske udvikling samt de ekstra ressourcer, medlemsstaterne, sundhedsinstitutionerne, de økonomiske aktører og andre relevante parter har behov for, bør anvendelsen af de relevante bestemmelser i forordning (EU) 2017/745 udskydes med et år.
English: (7) Both Directives 90/385/EEC and 93/42/EEC, as well as Regulation (EU) 2017/745, empower national competent authorities, on a duly justified request, to authorise the placing on the market of medical devices for which the relevant conformity assessment procedures have not been carried out, but the use of which is in the interest of protection of health, or in the interest of public health or patient safety or health respectively (‘national derogation').
Danish: (7) Både direktiv 90/385/EØF og 93/42/EØF samt forordning (EU) 2017/745 bemyndiger de nationale kompetente myndigheder til efter en behørigt begrundet anmodning at tillade markedsføring af medicinsk udstyr, for hvilket der ikke er gennemført relevante overensstemmelsesvurderingsprocedurer, hvis hensyn til henholdsvis sundhedsbeskyttelse eller folkesundhedshensyn eller hensynet til patienters sikkerhed eller sundhed taler herfor ("national undtagelse").
English: (6) The application should be deferred for provisions of Regulation (EU) 2017/745 that would otherwise start to apply from 26 May 2020.
Danish: (6) Anvendelsen af de bestemmelser i forordning (EU) 2017/745, som ellers ville begynde at finde anvendelse fra den 26. maj 2020, bør derfor udskydes.
English: (2) The COVID-19 outbreak and the associated public health crisis presents an unprecedented challenge to the Member States and is a high burden for national authorities, health institutions, EU citizens, and economic operators.
Danish: (2) Covid-19-udbruddet og den dermed forbundne folkesundhedskrise udgør en hidtil uset udfordring for medlemsstaterne og udgør en stor byrde for de nationale myndigheder, sundhedsinstitutionerne, EU-borgerne og de økonomiske aktører.
English: ‘The Member State may inform the Commission and the other Member States of any authorisation granted in accordance with Article 9(9) of Directive 90/385/EEC or Article 11(13) of Directive 93/42/EEC before [insert date - date of entry into force of this Regulation].
Danish: "Medlemsstaten kan underrette Kommissionen og de øvrige medlemsstater om alle tilladelser, der er givet i overensstemmelse med artikel 9, stk. 9, i direktiv 90/385/EØF eller artikel 11, stk. 13, i direktiv 93/42/EØF inden den [indsæt dato - datoen for denne forordnings ikrafttræden]."
English: The COVID-19 outbreak and the associated public health crisis presents an unprecedented challenge to the Member States and is a high burden for national authorities, health institutions, EU citizens and economic operators.
Danish: Covid-19-udbruddet og den dermed forbundne folkesundhedskrise udgør en hidtil uset udfordring for medlemsstaterne og udgør en stor byrde for de nationale myndigheder, sundhedsinstitutionerne, EU-borgerne og de økonomiske aktører.
English: ‘(f) Article 27(4) shall apply to class IIa and class IIb devices from 26 May 2023 and to class I devices from 26 May 2025;',
Danish: "f) "artikel 27, stk. 4, finder anvendelse på udstyr i klasse IIa og IIb fra den 26. maj 2023 og på udstyr i klasse I fra den 26. maj 2025".
English: Those extraordinary circumstances have a significant impact on various areas covered by Regulation (EU) 2017/745 and therefore it is very likely that Member States, health institutions, economic operators and other relevant parties will not be in a position to ensure the proper implementation and application of that Regulation from 26 May 2020 as it provides for.
Danish: Disse ekstraordinære omstændigheder har betydelige konsekvenser for forskellige områder, der er omfattet af forordning (EU) 2017/745, og det er derfor meget sandsynligt, at medlemsstaterne, sundhedsinstitutionerne, de økonomiske aktører og andre relevante parter ikke vil være i stand til at sikre en korrekt gennemførelse og anvendelse af forordningen fra den 26. maj 2020, som den ellers skulle anvendes fra.
English: ‘Following a notification pursuant to paragraph 2 of this Article, the Commission, in exceptional cases relating to public health or patient safety or health, may, by means of implementing acts, extend for a limited period of time the validity of an authorisation granted by a Member State in accordance with paragraph 1 of this Article or, when granted before [insert date - date of entry into force of this Regulation], in accordance with Article 9(9) of Directive 90/385/EEC or Article 11(13) of Directive 93/42/EEC to the territory of the Union and set the conditions under which the device may be placed on the market or put into service.
Danish: "På grundlag af en underretning, jf. denne artikels stk. 2, kan Kommissionen i undtagelsestilfælde vedrørende folkesundheden eller patienters sikkerhed eller sundhed ved hjælp af gennemførelsesretsakter udvide gyldigheden af en tilladelse, der er udstedt af en medlemsstat i overensstemmelse med denne artikels stk. 1, eller, hvis tilladelsen er givet inden den [indsæt dato - datoen for denne forordnings ikrafttræden], i overensstemmelse med artikel 9, stk. 9, i direktiv 90/385/EØF eller artikel 11, stk. 13, i direktiv 93/42/EØF, til Unionens område i en begrænset periode og fastsætte de betingelser, hvorpå udstyret kan bringes i omsætning eller ibrugtages.
English: (4) Given the unprecedented magnitude of the current challenges, and taking into account the complexity of Regulation (EU) 2017/745, it is very likely that Member States, health institutions, economic operators and other relevant parties will not be in a position to ensure the proper implementation and application of that Regulation from 26 May 2020 as it provides for.
Danish: (4) Som følge af de nuværende udfordringers hidtil usete omfang og under hensyntagen til kompleksiteten af forordning (EU) 2017/745 er det derfor meget sandsynligt, at medlemsstaterne, sundhedsinstitutionerne, de økonomiske aktører og andre relevante parter ikke vil være i stand til at sikre en korrekt gennemførelse og anvendelse af forordningen fra den 26. maj 2020, som den ellers skulle anvendes fra.
English: (b) the following indent is added:
Danish: b) Følgende led tilføjes:
English: (v) the following point (j) is added:
Danish: v) Følgende tilføjes som litra j):
English: It primarily aims at providing, for exceptional reasons in the context of the current COVID-19 outbreak, a one-year deferral as regards the date of application of certain provisions of that Regulation.
Danish: Det sigter primært mod at fastsætte en etårig udskydelse med hensyn til datoen for anvendelse af visse bestemmelser i nævnte forordning med det nuværende covid-19-udbrud som en ekstraordinær begrundelse.
English: (5) In order to ensure the smooth functioning of the internal market, a high level of protection of public health and patient safety, to provide legal certainty, and to avoid potential market disruption, it is necessary to defer the application of certain provisions of Regulation (EU) 2017/745.
Danish: (5) For at sikre et velfungerende indre marked og et højt beskyttelsesniveau for folkesundheden og patientsikkerheden, sikre retssikkerhed og undgå potentielle markedsforstyrrelser er det nødvendigt at udskyde anvendelsen af visse bestemmelser i forordning (EU) 2017/745.
English: (b) in paragraph 2, the following subparagraph is added:
Danish: b) I stk. 2 tilføjes følgende afsnit:
English: By way of derogation from Article 52 of this Regulation or, for the period from [insert date - date of entry into force of this Regulation] to 25 May 2021, by way of derogation from Article 9(1) and (2) of Directive 90/385/EEC or from Article 11(1) to (6) of Directive 93/42/EEC, any competent authority may authorise, on a duly justified request, the placing on the market or putting into service within the territory of the Member State concerned, of a specific device for which the applicable procedures referred to in those Articles have not been carried out but use of which is in the interest of public health or patient safety or health.
Danish: Uanset artikel 52 i denne forordning og, for perioden fra den [indsæt dato - datoen for denne forordnings ikrafttræden] til den 25. maj 2021, uanset artikel 9, stk. 1 og 2, i direktiv 90/385/EØF og artikel 11, stk. 1-6, i direktiv 93/42/EØF kan en kompetent myndighed efter en behørigt begrundet anmodning give tilladelse til, at et specifikt udstyr, for hvilket de i nævnte artikler omhandlede gældende procedurer ikke er blevet fulgt, kan bringes i omsætning eller ibrugtages på den pågældende medlemsstats område, hvis folkesundhedshensyn eller patienters sikkerhed eller sundhed taler herfor."
English: (i) implantable devices and class III devices from 26 May 2023;
Danish: i) implantabelt udstyr og udstyr i klasse III fra den 26. maj 2023
English: (1) Regulation (EU) 2017/745 of the European Parliament and of the Council establishes a new regulatory framework to ensure the smooth functioning of the internal market as regards medical devices covered by that Regulation, taking as a base a high level of protection of health for patients and users, and taking into account the small- and medium-sized enterprises that are active in this sector.
Danish: (1) Ved Europa-Parlamentets og Rådets forordning (EU) 2017/745 blev der indført en ny lovgivningsmæssig ramme med henblik på at sikre et velfungerende indre marked for det medicinske udstyr, der er omfattet af nævnte forordning, med udgangspunkt i et højt sundhedsbeskyttelsesniveau for patienter og brugere og under hensyntagen til de små og mellemstore virksomheder, der er aktive i sektoren.
English: Regulation (EU) 2017/745 of the European Parliament and of the Council, adopted on 5 April 2017, establishes a new regulatory framework to ensure the smooth functioning of the internal market as regards medical devices covered by that Regulation, taking as a base a high level of protection of health for patients and users, and taking into account the small- and medium-sized enterprises that are active in this sector.
Danish: Ved Europa-Parlamentets og Rådets forordning (EU) 2017/745, der blev vedtaget den 5. april 2017, blev der indført en ny lovgivningsmæssig ramme med henblik på at sikre et velfungerende indre marked for det medicinske udstyr, der er omfattet af forordningen, med udgangspunkt i et højt sundhedsbeskyttelsesniveau for patienter og brugere og under hensyntagen til de små og mellemstore virksomheder, der er aktive i sektoren.
English: (5) in Article 113, '25 February 2020' is replaced by '25 February 2021';
Danish: 5) I artikel 113 ændres "25. februar 2020" til "25. februar 2021".
English: (ii) class IIa and class IIb devices from 26 May 2025;
Danish: ii) udstyr i klasse IIa og IIb fra den 26. maj 2025
English: In order to ensure the smooth functioning of the internal market, a high level of protection of public health and patient safety, to provide legal certainty, and to avoid potential market disruption, it is necessary to defer the application of certain provisions of Regulation (EU) 2017/745 by one year.
Danish: For at sikre et velfungerende indre marked og et højt beskyttelsesniveau for folkesundheden og patientsikkerheden, sikre retssikkerhed og undgå potentielle markedsforstyrrelser er det nødvendigt at udskyde anvendelsen af visse bestemmelser i forordning (EU) 2017/745 med et år.
English: (8) Article 123 is amended as follows:
Danish: 8) Artikel 123 ændres således:
English: (iii) class I devices from 26 May 2027;',
Danish: iii) udstyr i klasse I fra den 26. maj 2027".
English: (2) Article 17 is amended as follows:
Danish: 2) Artikel 17 ændres således:
English: (3) in Article 34(1), ‘25 March 2020' is replaced by '25 March 2021';
Danish: 3) I artikel 34, stk. 1, ændres "25. marts 2020" til "25. marts 2021".
English: (6) Article 120 is amended as follows:
Danish: 6) Artikel 120 ændres således:
English: (1) in Article 1(2), the second subparagraph is amended as follows:
Danish: 1) Artikel 1, stk. 2, andet afsnit, ændres således:
English: (9) in point (h) of point 5.1 of Annex IX,'26 May 2020' is replaced by '26 May 2021'.
Danish: 9) I bilag IX, punkt 5.1, litra h), ændres "26. maj 2020" til "26. maj 2021".
English: (4) Article 59 is amended as follows:
Danish: 4) Artikel 59 ændres således:
English: (a) paragraph 5 is amended as follows:
Danish: a) Stk. 5 ændres således:
English: (f) paragraph 11 is amended as follows:
Danish: f) Stk. 11 ændres således:
English: (7) in Article 122, the first paragraph is amended as follows:
Danish: 7) Artikel 122, stk. 1, ændres således:
English: [XX.YY.YY.YY] NO NO NO NO
Danish: [XX.YY.YY.YY] NEJ NEJ NEJ NEJ
English: 13 Regional and Urban Policy
Danish: 13 Regionalpolitik og bypolitik
English: Such eligible expenditure shall not exceed EUR 200 000.
Danish: Sådanne støtteberettigede udgifter må højst udgøre 200 000 EUR.
English: There was no consultation of external stakeholders.
Danish: Der har ikke været nogen høring af eksterne interesseparter.
English: SPECIFIC OBJECTIVE No 1…[17: As described in point 1.4.2.
Danish: SPECIFIKT MÅL NR. 1...[17: Som beskrevet i punkt 1.4.2.
English: In the meantime, the effects on our economies and societies become ever more serious.
Danish: I mellemtiden bliver konsekvenserne for vores økonomier og samfund mere og mere alvorlige.
English: These measures are complementary and additional to the legislative modifications proposed on 13 March 2020.
Danish: Disse foranstaltninger kompletterer og supplerer de lovgivningsmæssige ændringer, der blev foreslået den 13. marts 2020.
English: These current limited and targeted changes do not require a separate impact assessment.
Danish: Disse begrænsede og målrettede ændringer forudsætter ikke en særskilt konsekvensanalyse.
English: The first package of measures proposed by the Commission on 13 March 2020 introduced a number of important changes that allow for a more effective response in the current situation.
Danish: Med den første pakke af foranstaltninger, som Kommissionen foreslog den 13. marts 2020, blev der indført en række vigtige ændringer, der giver mulighed for en mere effektiv reaktion i den nuværende situation.
English: Equally, the Commission will display the same flexibility in assessing the compliance of Member States with their obligations.
Danish: Kommissionen vil ligeledes udvise samme fleksibilitet ved vurderingen af, om medlemsstaterne opfylder deres forpligtelser.
English: (3) However, the serious negative effects on EU economies and societies are becoming worse.
Danish: (3) De alvorlige negative konsekvenser for EU's økonomier og samfund bliver imidlertid værre og værre.
English: Furthermore, certain procedural requirements linked to audits and financial instruments will be simplified.
Danish: Desuden vil visse proceduremæssige krav i forbindelse med revisioner og finansielle instrumenter blive forenklet.
English: National authorities could also consider the possibility to select new operations or to launch new or additional calls for proposals if necessary.
Danish: De nationale myndigheder kunne også overveje muligheden for at udvælge nye operationer eller iværksætte nye eller supplerende indkaldelser af forslag, hvis det er nødvendigt.
English: This has created an exceptional situation which needs to be addressed with specific measures.
Danish: Dette har skabt en ekstraordinær situation, som bør imødegås med specifikke foranstaltninger.
English: "Article [25a]
Danish: "Artikel [25a]
English: from candidate countries[13: Candidate countries and, where applicable, potential candidate countries from the Western Balkans.]
Danish: fra kandidatlande[13: Kandidatlande og, efter omstændighederne, potentielle kandidatlande på Vestbalkan.]
English: (1) the following new Chapter is added in Title II of Part Two:
Danish: 1) Følgende nye kapitel tilføjes i anden del, afsnit II:
English: In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary to achieve those objectives.
Danish: I overensstemmelse med proportionalitetsprincippet, jf. nævnte artikel, går denne forordning ikke videre, end hvad der er nødvendigt for at nå disse mål.
English: from EFTA countries[12: EFTA: European Free Trade Association. ]
Danish: fra EFTAlande[12: EFTA: Den Europæiske Frihandelssammenslutning. ]
English: 4 Employment, Social affairs and Inclusion
Danish: 4 Beskæftigelse, sociale anliggender, arbejdsmarkedsforhold og inklusion
English: Financial impact in 2020 - 2025
Danish: Finansielle virkninger fra 2020 til 2025
English: [10: Details of management modes and references to the Financial Regulation may be found on the BudgWeb site: http://www.cc.cec/budg/man/budgmanag/budgmanag_en.html]
Danish: [10: Forklaringer vedrørende forvaltningsmetoder og henvisninger til finansforordningen findes på webstedet BudgWeb: http://www.cc.cec/budg/man/budgmanag/budgmanag_en.html]
English: Such operations may be selected even before the necessary programme amendment is approved by the Commission.
Danish: Sådanne operationer kan udvælges, selv før de nødvendige programændringer er godkendt af Kommissionen.
English: In order to contribute to an effective response to the current crisis, the scope of support from the ERDF was considerably expanded.
Danish: For at bidrage til en effektiv reaktion på den nuværende krise blev anvendelsesområdet for EFRU-støtten udvidet betydeligt.
English: The transmission of the summary report prepared by the Commission in 2020, in accordance with Article 53(1), may be postponed accordingly.
Danish: Fremsendelsen af den sammenfattende rapport udarbejdet af Kommissionen i 2020, jf. artikel 53, stk. 1, kan udsættes i overensstemmelse hermed.
English: The COVID-19 outbreak is also likely to have serious impacts on the implementation of ongoing operations.
Danish: Covid-19-udbruddet vil sandsynligvis også få alvorlige konsekvenser for gennemførelsen af igangværende operationer.
English: The Commission will carefully monitor the impact of the proposed modification on payment appropriations in 2020 taking into account both the implementation of the budget and revised Member States forecasts.
Danish: Kommissionen vil nøje overvåge virkningen af den foreslåede ændring for betalingsbevillingerne i 2020 under hensyntagen til både gennemførelsen af budgettet og de reviderede overslag fra medlemsstaterne.
English: The direct and indirect effects of the COVID-19 outbreak continue to increase in all Member States.
Danish: De direkte og indirekte konsekvenser af covid-19-udbruddet vokser fortsat i alle medlemsstaterne.
English: Based on an assessment of the application of this exceptional co-financing rate, the Commission may propose an extension of this measure.
Danish: På grundlag af en vurdering af anvendelsen af denne ekstraordinære medfinansieringssats kan Kommissionen foreslå en udvidelse af denne foranstaltning.
English: DG: EMPL, REGIO 2020 2021 2022 2023 2024 2025 TOTAL
Danish: GD: EMPL, REGIO 2020 2021 2022 2023 2024 2025 I ALT
English: Payments =5+ 6
Danish: Betalinger =5+ 6
English: The proposal will facilitate an acceleration of programme implementation and resulting in a frontloading of payment appropriations.
Danish: Forslaget vil gøre det lettere at fremskynde gennemførelsen af programmet, hvilket vil føre til en fremrykning af betalingsbevillinger.
English: It provides clarity on the eligibility of expenditure affected by the measures put in place as a response to the public health crisis.
Danish: Det giver klarhed over støtteberettigelsen af udgifter, der er berørt af de foranstaltninger, der er truffet som reaktion på folkesundhedskrisen.
English: Furthermore, transfer possibilities between categories of regions should also be exceptionally increased for Member States given the widespread impact of the public health crisis, while respecting Treaty objectives for cohesion policy.
Danish: Desuden bør mulighederne for overførsel mellem regionskategorier også styrkes ekstraordinært for medlemsstaterne i betragtning af folkesundhedskrisens omfattende konsekvenser, samtidig med at traktatens mål for samhørighedspolitikken respekteres.
English: "CHAPTER V
Danish: "KAPITEL V
English: The deadline for the submission of the annual implementation reports for the year 2019 should be postponed, as should be the transmission of the Commission's summary report based on those annual implementation reports.
Danish: Fristen for indgivelse af de årlige gennemførelsesrapporter for 2019 bør udskydes, og det samme gælder fremsendelse af Kommissionens sammenfattende rapport baseret på disse årlige gennemførelsesrapporter.
English: [8: ABM: activity-based management; ABB: activity-based budgeting.]
Danish: [8: ABM: Activity Based Management (aktivitetsbaseret ledelse) - ABB: Activity Based Budgeting (aktivitetsbaseret budgetlægning).]
English: (Reference amount) Commitments =4+ 6
Danish: (referencebeløb) Forpligtelser =4+ 6
English: A Regulation is the appropriate instrument to introduce the additional flexibilities needed to address these unprecedented circumstances.
Danish: En forordning er det rette instrument til at indføre den yderligere fleksibilitet, der er nødvendig for at håndtere disse hidtil usete omstændigheder.
English: However, the proposal follows extensive consultations with Member States and the European Parliament over recent weeks, and takes account of the more than 200 clarification and advice questions received from national authorities concerning their handling of crisis response measures through the Coronavirus Response Investment Initiative Task Force.
Danish: Forslaget følger imidlertid omfattende høringer af medlemsstaterne og Europa-Parlamentet i de seneste uger og tager hensyn til de mere end 200 præciseringer og rådgivningsspørgsmål, som er modtaget fra de nationale myndigheder i forbindelse med deres håndtering af kriseberedskabsforanstaltningerne via taskforcen for investeringsinitiativet som reaktion på coronavirusset.
English: They result from the close cooperation with Member States through the Coronavirus Response Investment Initiative Task Force where over 200 questions have already been addressed.
Danish: De er resultatet af et tæt samarbejde med medlemsstaterne gennem taskforcen for investeringsinitiativet som reaktion på coronavirusset, som allerede har behandlet over 200 spørgsmål.
English: Resources under the European territorial cooperation goal, the additional allocations to outermost regions as well as support to the Youth Employment Initiative and the Fund for European Aid to the most Deprived should not be affected by such transfers.
Danish: Midler under målet om europæisk territorialt samarbejde, de supplerende tildelinger til regionerne i den yderste periferi samt støtte til ungdomsbeskæftigelsesinitiativet og Den Europæiske Fond for Bistand til de Socialt Dårligst Stillede bør ikke berøres af sådanne overførsler.
English: The Commission will assess and may propose on that basis an extension of this measure.
Danish: Kommissionen vil foretage en vurdering og på grundlag heraf foreslå en udvidelse af denne foranstaltning.
English: Furthermore, it is also proposed to allow for additional flexibility at the closure of programmes to ensure that available resources are used to the largest extent (Article 1(3)).
Danish: Det foreslås endvidere at give mulighed for yderligere fleksibilitet ved afslutningen af programmerne for at sikre, at de disponible midler anvendes i videst muligt omfang (artikel 1, stk. 3).
English: DG: <…….>
Danish: GD: <…….>
English: The total annual breakdown of commitment appropriations for the European Regional Development Fund, the European Social Fund and the Cohesion Fund remains unchanged.
Danish: Den årlige fordeling af forpligtelsesbevillinger til Den Europæiske Fond for Regionaludvikling, Den Europæiske Socialfond og Samhørighedsfonden forbliver uændret.
English: By way of derogation from Article 125(3)(b), such operations may be selected for support by the ERDF or the ESF prior to the approval of the amended programme.
Danish: Uanset artikel 125, stk. 3, litra b), kan sådanne operationer udvælges til støtte fra EFRU eller ESF inden godkendelsen af det ændrede program.
English: In particular, Partnership Agreements should no longer be amended until the end of the programming period neither to reflect prior changes in operational programmes nor to introduce any other changes.
Danish: Navnlig bør partnerskabsaftaler indtil udgangen af programmeringsperioden ikke længere ændres, hverken for at afspejle tidligere ændringer i de operationelle programmer eller for at indføre andre ændringer.
English: Type[16: Outputs are products and services to be supplied (e.g.: number of student exchanges financed, number of km of roads built, etc.).]
Danish: Type[16: Resultater er de produkter og tjenesteydelser, der skal leveres (f.eks.: antal finansierede studenterudvekslinger, antal km bygget vej osv.).]
English: Proposal/initiative in effect from 1/7/2020 to 30/6/2021
Danish: Forslag/initiativ gældende fra 1.7.2020 til 30.6.2021
English: [4: OJ C 91 I, 20.3.2020, p.
Danish: [4: EUT C 91 I af 20.3.2020, s.
English: The crisis hampers growth in Member States, which in turn aggravates the serious liquidity shortages due to the sudden and important increase in public investments needed in their health care systems and other sectors of their economies.
Danish: Krisen hæmmer væksten i medlemsstaterne, hvilket igen forværrer de alvorlige likviditetsmangler, der skyldes den pludselige og betydelige stigning i de offentlige investeringer, der er nødvendige i medlemsstaternes sundhedssystemer og andre sektorer i deres økonomier.
English: There may be instances in which circumstances resulting from the COVID-19 outbreak qualify as a force majeure event under national law and thus constitute a valid justification for the incapacity to comply with an obligation.
Danish: Der kan være tilfælde, hvor omstændighederne som følge af covid-19-udbruddet kan betegnes som en force majeure-begivenhed i henhold til national ret og dermed udgøre en gyldig begrundelse for manglende overholdelse af en forpligtelse.
English: To accommodate Member States' needs to tackle the current specific challenges, Member States should be able to request a transfer from their allocations for the year 2020 between categories of regions.
Danish: For at imødekomme medlemsstaternes behov for at håndtere de aktuelle specifikke udfordringer bør medlemsstaterne kunne anmode om en overførsel fra deres tildelinger for 2020 mellem regionskategorier.
English: Additionally, it is proposed to exempt Member States from the need to comply with thematic concentration requirements, to enable a redirection of resources to the areas most impacted by the current crisis.
Danish: Desuden foreslås det at fritage medlemsstaterne fra at skulle overholde kravene om tematisk koncentration, for at gøre det muligt at omdirigere midler til de områder, der er hårdest ramt af den aktuelle krise.
English: Member States and regions will be able to mobilise more resources for scaling up and extending short-time work schemes, for support to SMEs working capital and for immediate expenditure in the healthcare sector.
Danish: Medlemsstaterne og regionerne vil kunne mobilisere flere midler til at opskalere og udvide ordninger for nedsat arbejdstid, til støtte til SMV'ers arbejdskapital og til akutte udgifter i sundhedssektoren.