Tigh­ter requi­re­ments for manu­fac­tu­r­ers and increased lia­bi­li­ty risks

Medi­cal Device Regu­la­ti­on – clas­si­fi­ca­ti­on, qua­li­ty manage­ment, UDI label­ling and liability

An artic­le by Miri­am Schuh in the spe­cia­list jour­nal Haft­pflicht inter­na­tio­nal – Recht und Ver­si­che­rung (PHi), (“Inter­na­tio­nal public lia­bi­li­ty – law and insu­rance”) issue 2017, no. 5

Sin­ce May of this year, the new Euro­pean regu­la­ti­ons for medi­cal devices and in vitro dia­gno­stic medi­cal devices have been in force. The aim of the new regu­la­ti­ons is to crea­te a hig­her degree of safe­ty for pati­ents and users. Accor­din­gly, the obli­ga­ti­ons of manu­fac­tu­r­ers in par­ti­cu­lar have been exten­ded and tightened. 

Miri­am Schuh explains what real­ly mat­ters when it comes to clas­si­fi­ca­ti­on, qua­li­ty manage­ment, UDI and lia­bi­li­ty for manu­fac­tu­r­ers, and why the­re may be bot­t­len­ecks, par­ti­cu­lar­ly for small and medium-sized businesses. 

More infor­ma­ti­on on PHi, issue 2017, no. 5