Sustainability and ethical behaviour are becoming increasingly important, and the responsibility of companies for the quality and safety of their products is moving more and more into focus. In this context, the term “material compliance” is becoming increasingly important.

Sustainability is becoming a central issue for business success, so it is essential that companies consider their social and environmental responsibility alongside their economic performance. Material compliance plays a crucial role here, as it goes far beyond mere adherence to legal regulations. Ensuring compliance includes a comprehensive guarantee that the materials used in a product fulfil the legal requirements and are also ethically and ecologically acceptable. This applies to the entire life cycle of the materials, from purchasing and production through to disposal.

Material compliance is a key aspect for companies that want to demonstrate quality and a sense of responsibility. It is important to ensure that products fulfil legal requirements and at the same time meet the highest standards in terms of environmental compatibility, safety and ethics.

Integrating material compliance into the supply chain ensures compliance with legal regulations and promotes environmentally friendly production practices and the use of sustainable materials in line with the circular economy. This includes promoting recycling as an ecological principle and an integral part of product development. The holistic consideration of these elements ensures that companies act in compliance with the law and at the same time guarantee the environmentally friendly, safe and ethically responsible manufacturing of their products within the framework of the German Supply Chain Act or other national laws.

Material compliance in the context of the Medical Device Regulation (MDR):

The introduction of the Medical Device Regulation has presented companies in the MedTech industry with major challenges. The requirements are more complex and set higher standards for traceability, the handling of hazardous substances (SVHC) and material documentation.

Companies must fully document the entire life cycle of their products. This requires precise identification of the materials used and seamless monitoring along the entire production and supply chain. It must be ensured that medical devices are free from substances of very high concern or CMR substances. This requires a precise examination of the material composition and, if necessary, an adjustment of the material selection.

The MDR not only places increased demands on the documentation of substances. It also emphasises the obligation to report certain substances. These regulatory requirements demand that companies must collect and maintain comprehensive data on the materials used. In connection with the MDR, the introduction of the SCIP database (Substances of Concern In articles as such or in complex objects (Products)) should be mentioned in particular. The SCIP database is a central platform on which manufacturers are obliged to report information on substances of very high concern (SVHC) contained in their articles.

Coping with these regulations emphasises the importance of precise knowledge and constant monitoring of the materials used. Efficient documentation and the ability to respond quickly to requirements are crucial for compliance. Companies that proactively tackle these challenges increase both their compliance and the quality, safety and sustainability of their products.

Through various directives and regulations such as REACH, RoHS and CLP, the European Union has created a framework that focuses on material compliance. These regulations aim to ensure environmental, health and safety standards. Compliance is essential for companies and contributes to the safe and responsible handling of materials.

Image Material Compliance Process realised by seleon

The REACH Regulation is the central regulation for the

  • Registration,
  • Evaluation,
  • Authorisation and
  • Restriction

of chemical substances. Companies that manufacture, import or use chemical substances must comply with the provisions of REACH.

The RoHS Directive imposes restrictions on the use of certain hazardous substances in electrical and electronic equipment. In particular, the use of

  • Lead,
  • Mercury,
  • Cadmium,
  • Hexavalent chromium and
  • certain brominated flame retardants

is restricted in electronic products.

The CLP Regulation concerns the

  • Classification,
  • Labelling and
  • Packaging

of chemical substances and mixtures. It defines the criteria for the classification of substances and ensures that companies use clear and standardised labelling for their products.

All three regulations apply in principle in the European Union for products that are placed on the market in Europe (exceptions confirm the rule, as usual). They apply to manufacturers based both in Europe and outside Europe.

Advantages at a glance: The benefits of consistent material compliance

An effective material compliance process offers many benefits for companies, especially in an increasingly regulated and environmentally conscious business world. Compliance with the above regulations brings many important benefits. An established process ensures that it is adhered to all relevant laws and regulations relating to the materials used. This minimises the risk of legal consequences and sanctions. At the same time, material compliance promotes product safety, which strengthens consumer confidence and minimises health risks. Companies that participate in this process demonstrate social responsibility and ethical behaviour, which can strengthen their reputation and brand value.

A well-designed material compliance process enables companies to accurately identify and effectively manage material risks. Compliance with material standards is often a prerequisite for accessing certain markets and maintaining positive business relationships. Clear guidelines and efficient processes can not only contribute to cost savings and more efficient product development, they also help to minimise the impact on the environment. Given the growing demand for environmental responsibility, this is a crucial factor.

Clear material guidelines and efficient processes enable the optimised use of resources, which can lead to cost savings and more efficient product development. By integrating sustainable materials and practices, the process minimises environmental impact and meets the growing demand for environmental responsibility. Companies can explore innovative solutions and alternative materials to fulfil compliance and sustainability requirements. This creates competitive advantages and new business opportunities. In industries where sustainability is increasingly valued by consumers, a company that takes a strategic approach to material compliance can use it as a competitive advantage.

A well-established material compliance process is therefore not just a requirement to comply with regulations; it also represents a strategic investment that can have a positive impact on legal certainty, efficiency, reputation and innovation.

PFAS: A wake-up call for sustainable material compliance in companies

The current example of PFAS clearly shows how important it is to integrate material compliance practices into business processes.

PFAS is the abbreviation for “per- and polyfluoroalkyl substances”, often referred to as “perpetual chemicals”. This denotes more than 10,000 man-made fluorochemicals that are used in large quantities in the industry due to their outstanding technical properties, in particular their non-stick effect. According to a dossier from the European Chemicals Agency (ECHA), around 300,000 tonnes are produced annually in the EU alone (Annex XV reporting format 040615 ( PFAS accumulate in water and soil, are transported over long distances by wind and water and contaminate animal foodstuffs in particular, as established by the European Food Safety Authority (EFSA). Due to their longevity, they can accumulate in the environment and contaminate both water and soil, which can lead to direct ingestion by humans with possible long-term health risks.

In the coming years, a ban on PFAS and its extensive number of over 10,000 compounds will be introduced in the EU. In recent years, specific PFAS compounds such as PFOS (perfluorooctanesulfonic acid) and PFOA (perfluorooctanoic acid) have already been regulated and in some cases banned due to their persistent and bioaccumulating properties. Under chemical legislation, PFOS is classified as a PBT substance (persistent, bioaccumulative, toxic). The use and placing on the market of PFOS was banned Europe-wide by Regulation 850/2004/EC (“POP” Regulation), with a few exceptions. PFOA was still allowed to be used until 2020. Since 2020, PFOA, its salts and precursor compounds may neither be manufactured nor placed on the market.

The planned ban on PFAS will have a significant impact on all industries and pose enormous challenges and difficulties for companies. The previous bans on PFOS and PFOA serve as illustrative examples of how companies with an effective material compliance process could have analysed and assessed the likelihood of a ban on further PFAS compounds in advance (“predictive thinking”). This emphasises the importance of a proactive and forward-looking approach to material compliance in order to anticipate potential regulatory developments and come up with appropriate strategies.

Shaping the future: The essentials of sustainable material compliance

Sustainable material compliance is increasingly becoming a key concept in business that goes far beyond mere compliance with legal regulations. It is a comprehensive strategy that aims to organise the use of materials and resources in companies in such a way that ecological, social and economic aspects are given equal consideration. This approach reflects the growing awareness that long-term economic success is inextricably linked to sustainable behaviour.

The essence of sustainable material compliance is that responsible sourcing and use of materials protects the environment while establishing healthy and fair working conditions in the global supply chain. The companies that embark on the path of sustainability will realise that sustainable business is an investment in the future – an investment that minimises risks, increases efficiency and promotes innovation. Implementing such a strategy requires a holistic view of the entire value chain. From the selection of raw materials and production processes through to the end product and its life cycle, all steps are analysed. Particular attention is paid to minimising waste and emissions, promoting recycling and developing products that are suitable for a circular economy.

Integrating sustainable practices into the supply chain is a challenge that requires close collaboration with suppliers and partners. Transparency and mutual trust are essential to ensure that all parties involved adhere to the agreed standards. Pioneering companies often go above and beyond what is required and are actively committed to training and promoting their suppliers with regard to sustainable development. Taking sustainability criteria into account in the development process leads to products that are more durable, easier to repair and easier to recycle at the end of their life cycle. Such products not only meet the growing consumer demand for sustainable options, they also open up new business opportunities and contribute to differentiation in the market.

The role of the supply chain

A sustainable supply chain is the backbone of material compliance. Companies must ensure that their suppliers apply environmentally friendly practices, offer fair working conditions and refrain from using hazardous or banned materials. To achieve this, a close cooperation and transparency between all parties involved in the supply chain, from the raw material supplier to the end consumer, is essential. By implementing a sustainable supply chain, companies have the opportunity to reduce their environmental footprint while strengthening their brand reputation and gaining the trust of their customers. As part of supplier management in accordance with EN ISO 13485:2021, material compliance can be taken into account as a criterion.

Recycling and circular economy

Recycling is an essential part of sustainable materials management. By reusing or recycling materials, the need for new raw materials is reduced, which in turn reduces the environmental impact. The circular economy goes one step further and aims to avoid waste completely by keeping products and materials in a continuous cycle. This approach promotes sustainability and at the same time leads to cost savings by reducing material waste and improving material efficiency.

Product development process

Sustainable material compliance also has an impact on the product development process. Companies need to consider from the outset how their products can be recycled or reused at the end of their life cycle. This can influence design decisions, for example by choosing easily recyclable materials or designing products that can be easily dismantled, which may also be an advantage in the case of reprocessing activities. Such an approach requires rethinking in product development, but also offers the opportunity to create innovative and environmentally friendly products – right from the start and also for the benefit of other aspects to be considered under MDR and EN ISO 13485.

Material compliance signifies compliance with all relevant national and international laws, regulations and standards that govern the use of materials and substances in products. In the European Union, this includes the REACH Regulation, the RoHS Directive, the POP Regulation and the WEEE Directive, which regulates the return and proper disposal of waste electrical and electronic equipment. Companies that sell their products worldwide must also comply with country-specific directives and regulations.

We support you in the implementation of effective compliance management systems, carry out risk assessments and advise you on the selection of safe and compliant materials.

The approach is comprehensive and integrates material compliance and sustainability directly into the corporate strategy. Close collaboration with the involved teams is required to promote awareness and expertise in these important areas at all levels of your organisation.

Our aim is to support your company not only with short-term solutions, but also with sustainable and long-term solutions.

Please note that all details and listings do not claim to be complete, are without guarantee and are for information purposes only.