• 2022-12-27 08:46:16

This guidance is written for AR, manufacturers and other economic operators and provides clarification on relevant requirements under the Regulations.

• 2022-07-26 11:06:32

MDCG 2022-8 provides guidance regarding the applicability of IVDR requirements to "legacy devices" and "old" devices. The annex contains a non-exhaustive table illustrating IVDR requirements applicable or not applicable to “legacy devices”.

• 2022-06-29 02:11:11

MDCG 2022-5 is a guidance which provides elaboration of the borderline between medical devices and medicinal products, including relevant definitions and examples for these types of products, such as herbal products, substance-based devices and medical device and medicinal product combinations.

• 2021-06-29 11:30:23

On 25th June, Qualtech and ISS AG jointly hosted an enriching webinar session on the newly implemented Medical Device Regulation MDR (EU) 2017/745 (MDR) and the dynamic European medical device landscape. In this article, we are looking at the important points discussed.