News

Publication of the expert names

The IVDR requires the European Commission to create expert panels to support the scientific assessment and advice in the field of vitro diagnostic medical devices. Amongst others, the panels of experts will provide an opinion on the notified bodies’ assessments of performance evaluation of certain in vitro diagnostic medical devices. The European Commission has published the names of the experts (voir le panel n° 12).

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Information for the Industry from Swiss Medtech

The countdown for the MDR is on

The Expert Group Market Access is looking for new members!

Interested? Find out more here.

MDR Readiness Q&A

Go directly to the webinar series «MDR Readiness Q&A»

New Medtech@noon Webinar on 2 December 2020

Laser marking in times of UDI: legible and permanent

Harmonised standards under MDR

A request for harmonisation of standards was submitted to the European Commission for adoption and submission to the European Committee for Standardization and the European Committee for Electrotechnical Standardization (CEN/CENELEC). Annex I contains a list of 151 existing and 28 new standards with deadlines for their adoption.

Amendment to the Federal Act of 18 March 1994 on Health Insurance (cost containment measures – package 2)

Harmonised standards under IVDR

A request for harmonisation of standards was submitted to the European Commission for adoption and submission to the European Committee for Standardization and the European Committee for Electrotechnical Standardization (CEN/CENELEC). Annex II contains a list of 45 existing and 3 new standards with deadlines for their adoption.

Guidance on the classification of in vitro diagnostics

The European Commission’s Medical Device Coordination Group (MDCG) has released its much-anticipated guidance on the classification of in vitro diagnostics under the IVDR. The 50-page guidance explains to manufacturers, notified bodies and healthcare providers how IVDs should be classified before they are placed on the EU market.

Medtech industry requires now legal certainty

Timing plays a central role

From the Annual General Meeting

This is the new makeup of the Swiss Medtech Board.