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

Medical Devices

Medical Devices Regulation

The new Regulation on medical devices

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Red: No longer valid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
Commission Implementing Regulation 2023/1194	COMMISSION IMPLEMENTING REGULATION (EU) 2023/1194 of 20 June 2023 amending Implementing Regulation (EU) 2022/2346 as regards the transitional provisions for certain products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745 of the European Parliament and of the Council	R	NA-	2023-06-20	--