Update on EU regulatory developments Erik Hansson European - - PowerPoint PPT Presentation

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update on eu regulatory developments
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Update on EU regulatory developments Erik Hansson European - - PowerPoint PPT Presentation

Feb 24, 2023 325 likes •402 views

Update on EU regulatory developments Erik Hansson European Commission Health Technology and Cosmetics IMDRF 7 24-26 March 2015 Tokyo, JAPAN Revision of the EU Medical Devices Legislation -Background- Directive 90/385/EEC on active

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Update on EU regulatory developments

IMDRF – 7 24-26 March 2015 Tokyo, JAPAN

Erik Hansson European Commission Health Technology and Cosmetics

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Directive 90/385/EEC on active implantable medical devices Directive 93/42/EEC on medical devices Proposal for a Regulation on medical devices Directive 98/79/EC on in vitro diagnostic medical devices Proposal for a Regulation on in vitro diagnostic medical devices

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Revision of the EU Medical Devices Legislation

  • Background-
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  • European Parliament 1st reading vote : 2 April 2014
  • Council: discussions on the proposals ongoing - More

than 40 meetings of the Council Working Party under CY, IE, LT, EL, IT and LV Presidencies.

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Revision of the EU Medical Devices Legislation

  • State of play-
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Main issues subject to debate:

  • the pre-market control of high-risk medical devices;
  • the

designation, monitoring and functioning

  • f

notified bodies;

  • the reprocessing of single-use medical devices;
  • The regulation of certain products without a medical purpose

(aesthetic products);

  • CMR substances and endocrine disruptors;
  • the in-house exemption for high-risk IVDs;
  • counselling and informed consent in the case of genetic

tests;

  • New device identification and traceability requirements

and obligations of economic operators

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In the meantime…

  • The Commission and the Member States have been

implementing the Joint Plan for Immediate Action under the existing legislation in order to tighten up controls and improve patient safety.

  • A Staff Working Paper was published in June 2014
  • utlining the results of the Joint Plan for Immediate

Action, which had been achieved until then.

  • The Commission and the Member States are now

implementing a second step of measures agreed by Health Ministers.

  • The text of this Staff Working Document is available at http://ec.europa.eu/health/medical-devices/files/swd_pip_14_en.pdf -

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Thank you for your attention !

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Erik Hansson European Commission Health Technology and Cosmetics