Page 57 - angleška varianta sist - ODDANO-FINAL 4_1_2022_FLIPBOOK-spread

standards, to which the Directive/Regulation refers, provides presumption of
conformity of the product with its essential requirements.
Due to the COVID-19 pandemic and the resulting public health crisis, the CEN
and CENELEC member states, as well as the national authorities, healthcare
institutions and economic operators, have found themselves under severe
pressure. In response to the COVID-19 crisis, CEN and CENELEC have allowed,
through their national members, free access to the relevant European
standards, which should provide for faster and easier market access of the
basic medical and protection equipment. Examples of medical devices that are
used at present in response to the COVID-19 pandemic are: surgical masks,
medical gloves, surgical attire, ventilators (respirators), and the like.

57