Busi­ness Brunch Medi­cal Device Regulation

New obli­ga­ti­ons and lia­bi­li­ty risks!

Busi­ness brunch with Miri­am Schuh on 23 June 2017 in Düsseldorf

The MDR and the IVDR are now available in their final amend­ment and will be coming into force in the sum­mer of 2017. The manu­fac­tu­r­ers of medi­cal devices will have to face a lar­ge num­ber of new obli­ga­ti­ons and challenges.

Con­di­ti­ons gover­ning the respon­si­bi­li­ty of manu­fac­tu­r­ers for moni­to­ring the per­for­mance, qua­li­ty and safe­ty of their pro­ducts have been made more strin­gent. With the­se regu­la­ti­ons, the imple­men­ta­ti­on of the qua­li­ty manage­ment sys­tem is being stan­dar­di­sed in sta­tu­to­ry terms for the first time; manu­fac­tu­r­ers’ pro­duct sur­veil­lan­ce sys­tems are being rede­fi­ned, requi­re­ments rela­ting to tech­ni­cal docu­men­ta­ti­on and CAPA obli­ga­ti­ons inten­si­fied. Cli­ni­cal tests will in future requi­re to be car­ri­ed out over the enti­re life cycle of a medi­cal device. Pro­vi­si­on is to be made for lia­bi­li­ty in the case of defec­ti­ve pro­ducts, and that will tie up addi­tio­nal resour­ces. In addi­ti­on, the­re are UDI pro­duct label­ling obli­ga­ti­ons and wide-ranging report­ing obli­ga­ti­ons in respect of EUDAMED.

At the same time, manu­fac­tu­r­ers are requi­red to imple­ment the requi­re­ments of MEDDEV 2.71/1 rev. 4 orga­ni­sa­tio­nal­ly and to car­ry out the cer­ti­fi­ca­ti­on of their qua­li­ty manage­ment sys­tem in accordance with DIN EN ISO 13485:2016.

As from the time when the MDR and the IVDR come into force, the tar­get for manu­fac­tu­r­ers must be to make a struc­tu­red ana­ly­sis of what requi­re­ments actual­ly ari­se from the regu­la­ti­ons and to prepa­re them­sel­ves in orga­ni­sa­tio­nal terms for the CE mar­king in accordance with the new standards.

We look for­ward to dis­cus­sing the­se topics with you at our busi­ness brunch.