AMACO. The language of compliance is printed here
Medical device packaging has moved far beyond its traditional role as a sterile barrier. Today, it is the frontline of compliance, traceability, and patient safety. Under increasing scrutiny from MDR in Europe, FDA in the United States, and regulatory frameworks like REACH and EUDAmed, every package holds a product, yet what it truly conveys is trust.
This creates a dual challenge: ensuring that every unit complies with global rules while keeping packaging lines efficient, scalable, and sustainable. It is precisely in this space that AMACO positions itself as a trusted partner, delivering integrated inline printing and vision inspection solutions that transform compliance into a competitive advantage.
The rising tide of regulation
In recent years, health authorities have introduced increasingly detailed rules to ensure that every device is traceable, safe, and uniquely identifiable.
In the European Union, the Medical Device Regulation (MDR) requires all classes of devices to bear a Unique Device Identifier (UDI), with data uploaded to EUDAmed. In the United States, the FDA UDI Rule has already phased in across device classes, and since September 2023, all devices sold in the market must comply fully. Beyond identification, the REACH framework adds another layer of responsibility, pushing manufacturers to eliminate hazardous substances in inks and packaging materials.
These rules are designed to protect patients, prevent counterfeit products, and enable traceability in increasingly complex healthcare ecosystems. But for manufacturers, the implications are profound:
- Every package must carry a legible, durable, and scannable code, free of errors.
- Every ink used must avoid risks of migration into sterile products.
- Every packaging line must adapt without adding cost or delay.
Why packaging compliance is still a problem
Despite progress in automation, labeling and marking errors remain among the top causes of medical device recalls, representing up to 15–20% of events in the US and EU. A misprinted barcode, a missing character, or a code that cannot be scanned in the hospital setting can have consequences far beyond a product return. It can delay surgeries, put patients at risk, and damage the reputation of a trusted brand.
Another underestimated risk lies in the chemistry of inks. Studies by the European Food Safety Authority have shown that mineral-oil-based inks and UV inks can migrate through packaging materials, creating contamination risks for sterile pharmaceuticals and devices. This has accelerated a market-wide shift: over 60% of packaging producers in Europe are moving to mineral-oil-free, toxicological safe inks to align with safety expectations and REACH requirements.
And finally, there is the operational side. Manufacturers often face the dilemma of adding inspection as a separate process, slowing lines and increasing costs. This separation between printing and verification introduces gaps where errors slip through unnoticed until it’s too late.
AMACO’s integrated answer
AMACO’s philosophy is straightforward: compliance should be built into the packaging process itself. That is why our solutions combine high-resolution inline printing, 100% automated vision inspection, and validated mineral-oil-free inks into a single, seamless system.
Each package is printed, verified, and documented in one pass: high-resolution printers apply durable DataMatrix codes, barcodes, and variable data directly onto packaging materials, while integrated vision systems check every symbol for readability and correctness in real time, automatically rejecting non-conforming packs. This dual process eliminates the gap between marking and quality assurance.
There are no delays, no reliance on sampling, and no risk of unreadable codes reaching the market: only compliant identifiers, verified and approved directly in-line.
Safety in the formula, efficiency in the line
Compliance involves codes as well as the chemistry and operations behind them. AMACO has developed certified mineral-oil-free, toxicological safe inks designed specifically for medical device packaging. These inks meet REACH standards, prevent contamination risks, and are proven safe for sterile barrier systems. By making the switch, manufacturers reduce regulatory risks, protect patient safety, and meet the sustainability expectations of regulators and healthcare providers. Just as important, ink choice directly impacts waste management: traditional inks (e.g. UV-based, solvent-based, mineral-oil-based) are often classified as hazardous, driving up disposal costs and compliance overhead. Mineral-oil-free, toxicological safe inks can be treated as non-hazardous, lowering hidden costs while simplifying audits and reporting.
At the same time, AMACO systems are engineered to integrate seamlessly into thermoforming, tray, and pouching lines with minimal disruption. Cycle times remain intact, downtime is reduced, and compliance is achieved without compromising efficiency. Thanks to their modular design, the solutions are also future-proof: as regulations evolve and packaging formats change, the platform adapts, safeguarding investments for the long term.
The benefits in practice
When compliance and efficiency go hand in hand, the benefits are immediate and measurable:
- Confidence in compliance. Every printed code is verified for accuracy and readability, aligned with FDA and EUDAmed requirements.
- Reduced recall risk. By eliminating misprints and illegible codes, manufacturers address one of the leading causes of product recalls.
- Lower waste management costs. Mineral-oil-free inks avoid hazardous waste classification, reducing disposal expenses and simplifying compliance processes, while fulfilling tighter PPWR regulations.
- Improved efficiency. Inline verification replaces manual checks, reduces scrap, and accelerates batch release.
- Sustainability and safety. Mineral-oil-free inks protect patients while aligning with global moves toward safer, greener packaging.
In short, AMACO enables medical device companies to meet strict regulations without slowing down their lines or increasing costs.
Seizing opportunity in a market ready for change
The global medical device packaging market is projected to grow at 6–7% CAGR between 2023 and 2030, driven not only by rising healthcare demand but also by increasingly strict compliance standards. Inline vision inspection, once seen as optional, is rapidly becoming the industry norm. Early adopters that can prove compliance, safety, and sustainability are already gaining the trust of regulators and healthcare providers, positioning themselves as leaders in quality.
In this context, AMACO delivers solutions that speak directly to the needs of different stakeholders: for packaging leaders and operations managers, our systems secure uptime and yield while meeting compliance; for regulatory and quality teams, we provide audit-ready electronic records that link each printed code to device master data; for supply chain and engineering managers, our mineral-oil-free inks simplify global approvals and align with sustainability goals. Ultimately, addressing compliance challenges is just the starting point; the real goal is building a competitive edge in a market where safety, trust, and responsibility define success.
Compliance built in, not bolted on
Medical device packaging is at the center of a new regulatory landscape. Non-compliance can lead to costly recalls, reputational damage, and, most critically, risks to patient safety. At the same time, sustainability and operational efficiency are no longer negotiable.
AMACO stands out by integrating compliance, safety, and efficiency into a single solution. Inline printing with vision inspection, combined with certified mineral-oil-free inks, ensures packaging that is compliant today, adaptable tomorrow, and always safe for patients.
For manufacturers facing the complexity of MDR, FDA, REACH, and EUDAmed, the path forward is clear: build compliance directly into your packaging lines. And with AMACO, you have a partner that not only understands the regulations but turns them into an opportunity for leadership.
Every code tells a story of safety and trust. With AMACO, make sure yours is always the right one.