Commission Delegated Directive 2014/15/EU of 18 October 2013 amending, for the purposes of adapting to technical progress, the Annex IV to Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for lead, cadmium and hexavalent chromium in reused spare parts, recovered from medical devices placed on the market before 22 July 2014 and used in category 8 equipment placed on the market before 22 July 2021, provided that reuse takes place in auditable closed-loop business-to-business return systems, and that the reuse of parts is notified to the consumer
Proposed act with possible EEA relevance
Act under scrutiny by EEA EFTA
Draft Joint Committee Decision (JCD) under consideration
Entry into force of Joint Committee Decision (JCD) pending
Incorporated into the EEA Agreement and in force
Incorporated into the EEA Agreement but no longer in force
Legal status
EU legal act incorporated into the EEA Agreement by a Joint Committee Decision (JCD) Area (EEA Agreement)
II Technical Regulations, Standards, Testing and Certification
II.XV Dangerous Substances
Joint committee decision (JCD)
122/2014 In force in the EEA
Yes Legal documents
Commission Delegated Directive 2014/15/EU of 18 October 2013 amending, for the purposes of adapting to technical progress, the Annex IV to Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for lead, cadmium and hexavalent chromium in reused spare parts, recovered from medical devices placed on the market before 22 July 2014 and used in category 8 equipment placed on the market before 22 July 2021, provided that reuse takes place in auditable closed-loop business-to-business return systems, and that the reuse of parts is notified to the consumer
Framseld tilskipun framkvæmdastjórnarinnar 2014/15/ESB frá 18. október 2013 um breytingu á IV. viðauka við tilskipun Evrópuþingsins og ráðsins 2011/65/ESB, að því er varðar undanþágu fyrir blý, kadmíum og sexgilt króm í endurnotuðum varahlutum úr lækningatækjum sem eru sett á markað fyrir 22. júlí 2014 og notuð í búnað í 8. flokki sem er settur á markað fyrir 22. júlí 2021, að því tilskildu að sú endurnotkun fari fram í endurskoðunarhæfu, lokuðu skilakerfi fyrir viðskipti á milli fyrirtækja og að endurnotkun hlutanna sé tilkynnt neytendum, í því skyni að laga viðaukann að tækniframförum
Delegierte Richtlinie 2014/15/EU der Kommission vom 18. Oktober 2013 zur Änderung — zwecks Anpassung an den technischen Fortschritt — des Anhangs IV der Richtlinie 2011/65/EU des Europäischen Parlaments und des Rates hinsichtlich einer Ausnahme für Blei, Cadmium und sechswertiges Chrom in wiederverwendeten Ersatzteilen, die aus vor dem 22. Juli 2014 in den Verkehr gebrachten medizinischen Geräten ausgebaut werden und in vor dem 22. Juli 2021 in den Verkehr gebrachten Geräten der Kategorie 8 verwendet werden, sofern die Wiederverwendung in einem überprüfbaren geschlossenen zwischenbetrieblichen System erfolgt und den Verbrauchern mitgeteilt wird, dass Teile wiederverwendet wurden
Delegert kommisjonsdirektiv 2014/15/EU av 18. oktober 2013 om endring, med sikte på tilpasning til den tekniske utvikling, av vedlegg IV til europaparlaments- og rådsdirektiv 2011/65/EU med hensyn til unntak for bruk av bly, kadmium og seksverdig krom i ombrukte reservedeler som er gjenvunnet fra medisinsk utstyr som bringes i omsetning før 22. juli 2014, og som brukes i utstyr i kategori 8 som bringes i omsetning før 22. juli 2021, forutsatt at ombruken finner sted i kontrollerbare, lukkede retursystemer mellom bedrifter, og at forbrukeren informeres om at delene er ombrukte
History
28.06.2014
Adopted JCD confirmed entry into force date
28.06.2014
Compliance date in the EEA
27.06.2014
Adoption of Joint Commitee Decision (JCD) incorporating the act into the EEA Agreement
15.04.2014
Draft Joint Commitee Decision (JCD) incorporating the act into the EEA Agreement sent to Commission
18.10.2013
Adoption date in the EU
29.01.2014
Compliance date in the EU
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