Why PPWR mat­ters for device packaging

The Pack­ag­ing and Pack­ag­ing Waste Reg­u­la­tion (PPWR) applies broad­ly to pack­ag­ing placed on the EU mar­ket, includ­ing pack­ag­ing used for med­ical devices and in vit­ro diag­nos­tic med­ical devices devices. It does not replace the med­ical devices reg­u­la­tions (MDR and IVDR) oblig­a­tions. Instead, it adds a par­al­lel pack­ag­ing-com­pli­ance lay­er focused on trace­abil­i­ty, sus­tain­abil­i­ty, waste reduc­tion and clear­er sort­ing information.

Two waves of labelling change

The first wave is about iden­ti­fi­ca­tion. From 12 August 2026, pack­ag­ing must sup­port the iden­ti­fi­ca­tion of the respon­si­ble eco­nom­ic oper­a­tor. Where rel­e­vant, this may include the man­u­fac­tur­er and, for prod­ucts from out­side the EU, the importer.

The sec­ond wave (from August 2028 or 24 months after rel­e­vant Imple­ment­ing Act pub­li­ca­tion) is more vis­i­ble on the pack. Har­mo­nized label­ing require­ments are expect­ed to intro­duce com­mon infor­ma­tion on pack­ag­ing mate­r­i­al com­po­si­tion and sort­ing instruc­tions, using pic­tograms. These mea­sures are intend­ed to help users dis­pose of pack­ag­ing cor­rect­ly and sup­port a more con­sis­tent EU-wide approach.

The space prob­lem on med­ical device packs

Med­ical device pack­ag­ing often has lit­tle unused art­work space. Adding small­er text may solve a lay­out issue on paper, but it can weak­en usabil­i­ty. Adding more sym­bols may sup­port com­pli­ance, but it can also com­pete with safe­ty-crit­i­cal label­ing. The prac­ti­cal ques­tion is whether the user can still under­stand the pack quick­ly and correctly.

What to do now

The most effec­tive first step is a pack­ag­ing and art­work gap assess­ment. Iden­ti­fy affect­ed pack­ag­ing lev­els, con­firm reg­u­la­to­ry roles, review avail­able space, and decide whether infor­ma­tion can be reused, con­sol­i­dat­ed or moved to dig­i­tal access points. Start­ing ear­ly gives teams time to test lay­outs, avoid over-label­ing and pro­tect the read­abil­i­ty of safe­ty-relat­ed device information.

Source: Medtech Insight (an Infor­ma product)

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website