The process of devel­op­ing har­mo­nized stan­dards for Reg­u­la­tions (EU) 2017/745 and 2017/746 on med­ical devices and in vit­ro diag­nos­tic med­ical devices (MDR and IVDR) is still slow. Har­mo­nized stan­dards are an impor­tant foun­da­tion for com­pli­ance with the MDR and IVDR. If adhered to, man­u­fac­tur­ers may claim con­for­mance with the cor­re­spond­ing gen­er­al safe­ty and per­for­mance require­ments (GSPRs).

To date, there are only 17 har­mo­nized stan­dards under the MDR and 10 for the IVDR – although it was planned to include more than 200 for the Regulations. 

The last update to the stan­dards list was imple­ment­ed back in July 2023 with an amend­ed ref­er­ence for the MDR relat­ing to low tem­per­a­ture steam and formalde­hyde in the ster­il­i­sa­tion of health care prod­ucts and a new stan­dard for tests for skin sen­si­ti­sa­tion. The IVDR stan­dards update amends a stan­dard relat­ing to low tem­per­a­ture steam and formalde­hyde in the ster­il­i­sa­tion of health care prod­ucts only.

Source: Medtech Insight (an Infor­ma product)

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