reusch­law White­pa­per: Sus­taina­bi­li­ty requi­re­ments for medi­cal devices and IVDs

360°Compliance for medi­cal devices

Sus­taina­bi­li­ty is beco­ming incre­asing­ly important in the medi­cal tech­no­lo­gy indus­try and is beco­ming a regu­la­to­ry and eco­no­mic neces­si­ty as a result of the Euro­pean Green Deal and stric­ter requi­re­ments under the MDR (Regu­la­ti­on (EU) 2017/745) and IVDR (Regu­la­ti­on (EU) 2017/746). Envi­ron­men­tal­ly fri­end­ly mate­ri­als, resource-efficient pro­duc­tion and sus­tainable dis­po­sal are beco­ming incre­asing­ly important.

Our latest white­pa­per pro­vi­des an over­view of the key regu­la­to­ry deve­lo­p­ments in this area.

The focus is par­ti­cu­lar­ly on the fol­lo­wing EU regu­la­ti­ons and directives:

• Ecode­sign Regu­la­ti­on (EU) 2024/1781
• Defo­re­sta­ti­on Regu­la­ti­on (EU) 2023/1115
• Bat­tery Regu­la­ti­on (EU) 2023/1542
• WEEE Direc­ti­ve (EU) 2012/19

Vio­la­ti­ons of the­se regu­la­ti­ons can have serious con­se­quen­ces, such as fines, civil lia­bi­li­ty, sales bans, pro­duct recalls and dama­ge to repu­ta­ti­on. To mini­mi­se the­se risks, we recom­mend intro­du­cing a 360° com­pli­ance manage­ment sys­tem and sys­te­ma­tic legal moni­to­ring updates.

Learn more about the cur­rent and future sus­taina­bi­li­ty requi­re­ments for medi­cal devices and IVDs in our detail­ed white paper.

The com­ple­te white­pa­per is available for down­load here.