As the European Union intensifies its transition toward a circular, climate-neutral economy, healthcare manufacturers are facing an increasingly complex web of environmental and sustainability regulations. Addressing attendees at the recent Regulatory Intelligence Conference Europe in Barcelona, legal experts Cécile van der Heijden and Jilles van der Hoek of Axon Lawyers warned that navigating this landscape requires a shift from reactive compliance to a proactive, integrated management strategy.
The regulatory burden on medical device and pharmaceutical firms has evolved significantly. Beyond industry-specific frameworks like the Medical Device Regulation (MDR) and the proposed New Pharmaceutical Legislation, companies are now tethered to broader environmental mandates, including the Battery Regulation and the Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH). The attorneys cautioned that overlapping legislation does not allow for a “pick and choose” approach; rather, manufacturers are obligated to harmonize their internal processes to meet all applicable requirements, regardless of whether a provision is industry-specific or cross-sectoral.
With the year 2027 looming as a critical juncture for environmental enforcement—including the implementation of penalties under the Packaging and Packaging Waste Regulation (PPWR)—van der Heijden advised companies to abandon the attempt to track all legislation globally. Instead, she recommended a targeted “product-by-legislation” matrix. This approach involves mapping requirements specifically to a firm’s portfolio, categorizing obligations by product, components, substance composition, and end-of-life disposal.
“You need to bring the information together,” van der Heijden noted. “If it exists across 15 files or 15 different people, no one has the overview, and that is what you want to avoid.”
A core challenge for many manufacturers lies in defining their legal role within the supply chain. Because a company may act as a manufacturer under one regulation but an importer or distributor under another, the experts emphasized that internal teams cannot rely solely on their MDR or IVDR designations. They pointed to the EU Blue Guide as an essential resource for clarifying these roles and ensuring consistent compliance across disparate legal regimes.
Operational implementation requires more than just internal policy; it necessitates robust contractual leverage. As environmental data often resides with third-party vendors, manufacturers must embed compliance requirements into supplier agreements. By establishing explicit specifications for materials, recycling capabilities, and information transparency, firms gain the legal standing to enforce compliance and demand evidence. Van der Heijden stressed that these contracts serve as a critical defense, ensuring that suppliers provide the necessary technical documentation to satisfy evolving regulatory scrutiny.
However, compliance is not a static state. The experts urged companies to establish “internal reassessment triggers”—formal procedures that initiate a review whenever a design change, a shift in material sourcing, or a new substance restriction occurs. Without these embedded triggers, documentation can quickly become obsolete, creating significant gaps that leave the firm vulnerable during inspections.
The risk of non-compliance is compounded by the structure of EU enforcement. While regulations are often harmonized, oversight and the imposition of penalties are managed at the national level. Authorities across member states are increasingly coordinating and sharing data, meaning a failure to comply in one market can trigger broader regulatory scrutiny across the entire European Economic Area.
“If there is enforcement in one member state, it is very likely that other member states will look at your products,” van der Heijden warned.
While many of the upcoming environmental requirements have yet to see their full punitive frameworks enacted, the experts concluded that companies should not mistake a lack of current penalties for a lack of risk. Authorities maintain the power to restrict, prohibit, or withdraw products from the market, or force costly recalls. For the healthcare industry, the path forward is clear: integrate environmental compliance into the core of product development and supplier management to avoid the significant operational and financial consequences of regulatory drift.
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