Does the exemption from the old Directive still apply?

Not automatically. The PPWR defines packaging broadly, essentially anything that contains, protects, handles, delivers or presents a product without being an integral part of it, and applies obligations to manufacturers, importers, distributors and brand owners alike. Some duties reach device packaging in full; others are scaled back where sterility or patient safety genuinely require it. The distinction depends on which of three tiers a given piece of packaging falls into:

  • Integral to the device itself: components like an IV bag, a syringe barrel or a catheter that deliver or contain the device’s function are not “packaging” at all under the PPWR; they stay governed exclusively by MDR/IVDR.
  • Sterile barrier or primary packaging: pouches, trays, lids and blisters that maintain sterility or protect the device sit outside most PPWR design obligations, though conformity assessment, the PFAS and heavy-metal limits, and Extended Producer Responsibility (EPR) still apply to them.
  • Secondary, tertiary or e-commerce packaging: grouping cartons, shelf boxes, shippers and transport packaging get no exemption whatsoever; every PPWR requirement applies in full.

What actually has to change on the packaging itself?

Several obligations bite regardless of tier. Heavy-metal limits carried over from the old Directive (a combined cap of 100 mg/kg for lead, cadmium, mercury and hexavalent chromium) remain in force, and from 12 August 2026 food-contact packaging additionally faces a ban on PFAS above 25 ppb for any single substance or 250 ppb in total. Every packaging type placed on the market from that date also needs its own technical documentation and an EU Declaration of Conformity, plus registration and eco-modulated EPR fees under Article 45, fees that will scale with how recyclable, or not, a given design turns out to be.

Recyclability itself works on a graded A to E scale. From 1 January 2030, only grades A through C will remain marketable, and grade C is due to be phased out entirely from 2038. Minimum recycled-content thresholds for plastic packaging begin the same year, 2030, and rise through 2040. Packaging weight and empty space face their own ceiling too: from 2030, grouped, transport and e-commerce packaging is capped at 50% empty space, on top of a general obligation to keep packaging minimised to what functionality actually requires.

Where do MDR and IVDR labelling and PPWR sorting labels collide?

Physically, on the same pack. The PPWR introduces harmonised, material-composition sorting labels to be phased in through implementing acts, and these now have to sit alongside the UDI and ISO 15223 symbols that MDR and IVDR already require. That is not merely a cosmetic overlap; artwork space on primary and secondary packaging is finite, and manufacturers will need to plan layouts that satisfy both regimes without compromising legibility of either. One further wrinkle worth flagging early: the EPR authorised representative required under the PPWR is a separate legal role from the EC REP or EU REP appointed under MDR or IVDR, and the two should not be assumed to be interchangeable.

Nothing here is final and closed. The recycled-content exemption currently available to medical devices and IVDs under Article 7(4) carries no expiry date in the current text, but the Commission is due to reassess recycled-content exemptions generally from 2028, and to review the substances-of-concern and design-for-recycling regime by 2033. Manufacturers who treat the next few years as a design window, reworking cartons and outer packaging before the grading and content thresholds tighten, are likely to manage the transition considerably more comfortably than those who wait for the deadlines to arrive.

Based on the requirements outlined above, we suggest the following practical actions to prepare for PPWR compliance:

  • Map every packaging item against the three-tier scope logic.Go through your full portfolio and classify each packaging component as integral to the device (outside PPWR), sterile barrier/primary packaging (partially exempt), or secondary/tertiary/e-commerce packaging (fully in scope). This determines which obligations actually apply to which item.
  • Start gap assessments and supplier documentation now.Every packaging type needs a Declaration of Conformity and technical file from 12 August 2026, so begin collecting PCR (post-consumer recycled content) chain-of-custody records and PFAS test data from suppliers without delay.
  • Treat the current grace period as a design window. The recyclability grading (A to E) and recycled-content thresholds tighten progressively through 2030 to 2038. Redesigning cartons and outer packaging early, rather than waiting for deadlines, will reduce both cost and supply-chain risk.
  • Plan artwork layouts that accommodate both MDR/IVDR and PPWR labelling. UDI and ISO 15223 symbols must coexist on the same pack with the new harmonised PPWR sorting labels. Secure space and legibility for both before the labelling requirements are phased in.
  • Clarify the EPR authorised representative role separately from your EC REP/EU REP. These are distinct legal appointments under different regulations. Confirm who fulfils each role and register accordingly under Article 45.
  • Prioritise secondary and transport packaging first. Unlike primary sterile barriers, this packaging tier carries no exemptions at all: recyclability grading, recycled content, minimisation and labelling obligations apply in full from the applicable dates.
  • Monitor the scheduled reviews. The Commission is due to reassess recycled-content exemptions from 2028 and the substances-of-concern/design-for-recycling regime by 2033. Build periodic compliance reviews into your quality system so future tightening doesn’t arrive as a surprise.
  • Budget for eco-modulated EPR fees. Since fees scale with recyclability performance, factor the cost impact of less-recyclable designs into packaging decisions now, rather than after fee schedules are finalised.

Link to the document:
Packaging and Packaging Waste Regulation (PPWR), Regulation (EU) 2025/40