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New standards

News in the area of guidelines and standards

Last update: Q3 2023

Standardization is an ongoing process, trying to keep up with the 'state of art' of technology. As a result, standards are being updated and replaced in an increasing rate. Keeping up to date is a laborious task. Kiwa Dare monitors the changes and report them on this page for you. In this regular column, we'll try to keep you as much as possible up to date of changes and expected modifications.

Important Notices:

These pages contain the most commonly used standards and guidelines by Kiwa Dare. Standards not included in this overview can be applied on request. A complete overview of harmonized standards is included in the overview (if applicable).

bekijk de tabel Medical Devices Regulation

Electromagnetic Compatibility (EMC)

Medical Devices Regulation

Legenda:

In the column 'Status' the following codes are used:
  • A: Amendment
  • B: Basic standard
  • C: Correction
  • G: Generic standard
  • H: Harmonised standard
  • P: Product standard
  • D: Directive
  • R: Regulation
  • TR: Technical Reference
  • M: Manufacturer specific requirements

The validity of the standards/directives etc. is color coded:
  • Green: Valid
  • Orange: Will be changed or replaced soon
  • Red: No longer valid
  • Blue: Transition period
  • Yellow: Can be used as technical reference document
« back to Medical Devices Regulation

Identification Description Status Version Date of issue Remarks
European standards

Updated list of harmonised standards for Medical devices

 TR NA- 2017-11-17 --
Decision 2021/1182

Commission Implementing Decision (EU) 2021/1182 of 16 July 2021 on the harmonised standards for medical devices drafted in support of Regulation (EU) 2017/745 of the European Parliament and of the Council

 NA- 2021-07-16 --
Decision 2022/6

COMMISSION IMPLEMENTING DECISION (EU) 2022/6 of 4 January 2022 amending Implementing Decision (EU) 2021/1182 as regards harmonised standards for biological evaluation of medical devices, sterilisation of health care products, aseptic processing of health care products, quality management systems, symbols to be used with information to be supplied by the manufacturer, processing of health care products and home light therapy equipment.

 A NA- 2022-01-04 --
Decision 2022/757

COMMISSION IMPLEMENTING DECISION (EU) 2022/757 of 11 May 2022 amending Implementing Decision (EU) 2021/1182 as regards harmonised standards for quality management systems, sterilisation and application of risk management to medical devices

 A NA- 2022-05-11 --
Decision 2023/1410

COMMISSION IMPLEMENTING DECISION (EU) 2023/1410 of 4 July 2023 amending Implementing Decision (EU) 2021/1182 as regards harmonised standards for sterilization of health care products and biological evaluation of medical devices

 A NA- 2023-07-04 --

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