UK approved bodies for medical devices

“UK approved bodies listed under Medical Devices Regulations 2002 (UK MDR 2002)”

Fonte: www.gov.uk

aggiornato al 30 Luglio 2021

tipi di dispositivi medici per i quali l’organismo è autorizzato a rilasciare la certificazione UKCA:

• Medical Devices
  • Under Part II of the Medical Devices Regulation as they apply in Great Britain (SI 2002 NO 618, as amended) (UK MDR 2002)
  • Under Part II of the Medical Devices Regulation as they apply in Northern Ireland (SI 2002 NO 618, as amended) (UK MDR 2002) until 25 May 2021
• Active Implantable Medical Devices
  • Under Part III of the Medical Devices Regulation as they apply in Great Britain (SI 2002 NO 618, as amended) (UK MDR 2002)
  • Under Part III of the Medical Devices Regulation as they apply in Northern Ireland (SI 2002 NO 618, as amended) (UK MDR 2002) until 25 May 2021
• In-vitro Diagnostics Medical Devices
  • Under Part IV of the Medical Devices Regulation as they apply in Great Britain (SI 2002 NO 618, as amended) (UK MDR 2002)
  • Under Part IV of the Medical Devices Regulation as they apply in Northern Ireland (SI 2002 NO 618, as amended) (UK MDR 2002) until 25 May 2022

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