Page 56 - angleška varianta sist - ODDANO-FINAL 4_1_2022_FLIPBOOK-spread

AN ANALYSIS INTO THE IMPACT OF STANDARDS ON THE OPERATION OF SLOVENIAN COMPANIES

During the coronavirus pandemic in Slovenia, good examples have been set by:
The National Institute of Chemistry Ljubljana, who started innovative development
of vaccine products; BIA Separations Group Ajdovščina, who invested into
innovation activity in eight international projects for development of vaccine
against coronavirus; and several Slovenian companies and R&D institutions
under the guidance of Technology Park Ljubljana, who participated in an
innovation project of developing a prototype respirator.

European health standards ensure to the users a safe access to healthcare,
and lay down the safety, quality and efficiency requirements for medical
devices.

In the healthcare sector, over 20 TCs within CEN and CENELEC are preparing
European standards with requirements regarding safety, quality and efficiency
of medical devices to be placed on the European market. Many of the
standards allow producers to harmonise their products and services with
European legislation, which is to the greatest benefit of European citizens.

Slovenian Institute for Standardization has established a technical
committee, SIST/TC VAZ Health Protection, whose experts keep a watchful eye
on all development stages of the standardization documents of all 20 CEN and
CENELEC TCs in this field. The relevant Slovenian TC submits all draft
European standards to public inquiry, normally with 30 days free access to the
documents. Anyone having comments on standardization documents during
public inquiry, may submit them via the SIST public inquiry web portal. The
members of SIST/TC VAZ Health Protection shall transpose all issued ENs into
Slovenian Standards within 6 months of their publication at the latest.

The basic requirements for healthcare are laid down in three EU Directives (on
medical devices; on implantable medical devices; and on in vitro diagnostic
medical devices), which have been revised into two new Regulations, namely:
Regulation (EU) 2017/745 On Medical Devices (MDR), and Regulation (EU)
2017/426 On In Vitro Diagnostic Medical Devices (IVDR). The use of harmonised

56 SIST - SLOVENIAN INSTITUTE FOR STANDARDIZATION