New standards

News in the area of guidelines and standards

Last update: Q3 2024

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Red: No longer valid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	--
Decision 2024/815	COMMISSION IMPLEMENTING DECISION (EU) 2024/815 of 6 March 2024 amending Implementing Decision (EU) 2021/1182 as regards harmonised standards for medical gloves for single use, biological evaluation of medical devices, sterilization of health care products, packaging for terminally sterilized medical devices and processing of health care products.	A	NA-	2024-03-06	--