Regulatory Skeleton of Medical Devices in the European Union

  • Soundarya Reddy Kalva Individual
  • Sahitya Reddy Kalva
  • Haripriya

Abstract

‘Medical device’ means any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings, for one or more of the specific medical purpose(s).  Medical devices make an essential contribution to healthcare in the Europe for the benefit of European citizens. These products must undergo a conformity assessment to demonstrate that they meet legal requirements to ensure they are safe and perform as intended. The European Medicines Agency (EMA) is responsible for the scientific evaluation of a product through centralized marketing authorisation applications (MAA). In order to commercialize medical devices in the European Union, a (European Conformity) CE Mark certificate is needed.

Keywords: Medical Device, European Commission, MDR, Centralized Procedure, European Medicines Agency

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References

1. Europe. European Medicines Agency, Human regulatory, Medical devices: Overview. Europe [Internet]. EMA; 1995-2020 [cited 2023 Aug 13]. Available from:
https://www.ema.europa.eu/en/human-regulatory/overview/medical-devices
2. KOBRIDGE-Europe Medical Device Registration [Internet]. Korea: Medical Device Registration; 2020 [cited 2023 Aug 13]. Available from:
https://kobridgeconsulting.com/europe-medical-device-registration
3. EMERGO, by UL. Global: Europe CE Marking Regulatory Process for Medical Devices [Internet].EMERGO; 2019 [cited 2023 Aug 13]. Available from:
https://www.emergobyul.com/resources/europe-process chart#:~:text=In%20order%20to%20commercialize%20medical,they%20apply%20to%20your%20product
4. Max Stralin. CE check Support. Classification of Medical Devices and their Routes to CE Marking [Internet]. 2020 Jan [cited 2023 Aug 13]. Available from:
https://support.ce-check.eu/hc/en-us/articles/360008712879-Classification-Of-Medical-Devices-And-Their-Routes-To-CE-Marking
5. British Standards Institute. Ibim Tariah Technical Expert: BSI Americas Rebecca Pine, Medical Devices Consultant. Effective Post-market Surveillance: BSI/UK/440/ST/ 0614/en/HL [Internet]. [cited 2023 Aug 13]. Available from:
https://bsigroup.com
6. EUROPA, EUR-Lex-02017R0745-20170505EN. Regulation (EU) 2017/745 of the European Parliament and of the Council: EU [Internet]. eur-lex; 2020 Apr 24 [cited 2023 Aug 13]. Available from:
https://eur-lex.europa.eu/eli/reg/2017/745/2017-05-05
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How to Cite
Kalva, S. R., Sahitya Reddy Kalva, and Haripriya. “Regulatory Skeleton of Medical Devices in the European Union”. International Journal of Drug Regulatory Affairs, Vol. 11, no. 4, Dec. 2023, pp. 34-38, doi:10.22270/ijdra.v11i4.630.