Medical Writing Medical Devices Medical Device Regulation: A necessary step towards more patient and user safety
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Volume 26, Issue 2 - Medical Devices

Medical Device Regulation: A necessary step towards more patient and user safety

Abstract

Abstract

The new Medical Device Regulation (MDR) has recently been approved, and after a transition period of 5 years, all medical devices will be approved and marketed according to these new regulations. This article compares the main changes of the MDR to the still-valid Active Implantable Medical Device Directive (AIMD) and Medical Device Directive (MDD). Some changes will have a great impact on the way that devices are marketed, but many others are unpredictable and may disrupt the medical device market. Until manufacturers and authorities adapt to the changes, the transition years will pose difficulties for all stakeholders
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References

  1. The Global Harminization Task Force. 2017 [cited 2017 Jan 20]. Available from: http://www.ghtf.org/ (accessed on 20 January 2017)
  2. European Commision. Medical Devices, Specific Areas of Development. 2017 [cited 2017 Jan 20]. Available from: http://ec.europa.eu/growth/sectors/medical-devices/specific-areas-development_de
  3. EMERGO. The Future of Eudamed – Bigger, Better, Riskier. 2017 [cited 2017 Mar 17]. Available from: https://www.emergogroup.com/de/blog/ 2016/02/die-zukunft-von-eudamedbesser-groesser-riskanter
  4. Eur-Lex. 2017 [cited 2017 Jan 20]. Available from: http://eur-lex.europa.eu

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