News

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.

Manufacturers of Class I medical devices

To help manufacturers of Class I medical devices comply with MDR, the Irish HPRA has compiled a crystal-clear list of key activities to complete. For each activity, the document refers to the relevant articles in the legislation.

Solid basis for next important step with Europe

Swiss Medtech calls for quick, pragmatic solution for medtech industry

The Swiss Medtech Award 2020 goes to Rheon Medical and Coat-X

Two start-ups from western Switzerland revolutionise the treatment of glaucoma

The Swiss Medical Technology Industry

Sector Study 2020

Medtech Sector Study 2020

Swiss medical technology industry is robust