September 2022
Team-NB General Assembly
The association meeting is scheduled on October 5th
August 2022
MDCG guidance
The MDCG endorsed document advised actions such as hybrid audits, [...]
Draft Commission Implementing Regulation as regards reclassification of groups of certain active products without an intended medical purpose
Published for 4 weeks consultation (document accessible to https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/12972-Medical-devices-reclassification-of-products-without-an-intended-medical-purpose_en
FAQ document from Commission
The Commission published Frequently asked questions on medecines and medical [...]
July 2022
Position paper: Conformity assessment of multiplex assays
Team-NB-PositionPaper-ConfAssessment-Multiplexassays-V1 Thanks to the work of the IVD working group, [...]
June 2022
MDCG 2022-11 – Position Paper
The “Notice to manufacturers to ensure timely compliance with MDR [...]
Draft “Commission Implementing Decision on a standardisation request”
The draft published today in the “Notification system” of European [...]
May 2022
IVD in Swiss in absence of MRA
In the absence of an update of the MRA to [...]
List of references
Harmonised European standards in support of the Medical Devices Regulation [...]
Team-NB MD Sector Survey PressRelease
The annual Team-NB sector press release is available via the [...]