COCIR’s Standardisation Policy Working Group monitors international and European standardisation activities and issues industry recommendations when required to support regulatory frameworks in Europe and beyond. The goal is to maximise the use of international standards to support smart regulations and avoid technical barriers when accessing markets in Europe and beyond.

International Level

COCIR was granted liaison of category A with the Technical Committee 62 of the International Electrotechnical Commission (IEC).  This technical committee is in charge of international standards covering electromedical equipment.  This category A liaison allows COCIR to submit new work item proposals (NWIP) at international level, to be considered as potential future international standards subject to approval by the National Committee Members of Technical Committee 62 of the IEC.

European Level

At European level, COCIR is a member of CEN-CENELEC’s Advisory Board for Healthcare Standards (ABHS) as well as the SMARRT Roundtable and Joint Initiative on Standardisation coordinated by the European Commission. COCIR is thus deeply engaged in the discussion on the harmonization of standards in Europe, especially in view of the need for Harmonised Standards under the Medical Device Regulation.