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Recital 98

Recital 98

(98)Directives 90/385/EEC and 93/42/EEC should be repealed to ensure that only one set of rules applies to the placing of medical devices on the market and the related aspects covered by this Regulation. Manufacturers' obligations as regards the making available of documentation regarding devices they placed on the market and manufacturers' and Member States' obligations as regards vigilance activities for devices placed on the market pursuant to those Directives should however continue to apply. While it should be left to Member States to decide how to organise vigilance activities, it is desirable for them to have the possibility of reporting incidents related to devices placed on the market pursuant to the Directives using the same tools as those for reporting on devices placed on the market pursuant to this Regulation. It is furthermore appropriate, in order to ensure a smooth transition from the old regime to the new regime, to provide that Commission Regulation (EU) No 207/2012 28 and Commission Regulation (EU) No 722/2012 29 should remain in force and continue to apply unless and until repealed by implementing acts adopted by the Commission pursuant to this Regulation. Decision 2010/227/EU adopted in implementation of those Directives and Directive 98/79/EC should also remain in force and continue to apply until the date when Eudamed becomes fully functional. Conversely, no such maintenance in force is required for Commission Directives 2003/12/EC 30 and 2005/50/EC 31 and Commission Implementing Regulation (EU) No 920/2013 32 .

  1. 28 Commission Regulation (EU) No 207/2012 of 9 March 2012 on electronic instructions for use of medical devices ( OJ L 72, 10.3.2012, p. 28 ). ↩
  2. 32 Commission Implementing Regulation (EU) No 920/2013 of 24 September 2013 on the designation and the supervision of notified bodies under Council Directive 90/385/EEC on active implantable medical devices and Council Directive 93/42/EEC on medical devices ( OJ L 253, 25.9.2013, p. 8 ). ↩
  3. 29 Commission Regulation (EU) No 722/2012 of 8 August 2012 concerning particular requirements as regards the requirements laid down in Council Directives 90/385/EEC and 93/42/EEC with respect to active implantable medical devices and medical devices manufactured utilising tissues of animal origin ( OJ L 212, 9.8.2012, p. 3 ). ↩
  4. 31 Commission Directive 2005/50/EC of 11 August 2005 on the reclassification of hip, knee and shoulder joint replacements in the framework of Council Directive 93/42/EEC concerning medical devices ( OJ L 210, 12.8.2005, p. 41 ). ↩
  5. 30 Commission Directive 2003/12/EC of 3 February 2003 on the reclassification of breast implants in the framework of Directive 93/42/EEC concerning medical devices ( OJ L 28, 4.2.2003, p. 43 ). ↩
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