Contract management for medical devices

In the medical device sector, contracts are far more than just commercial agreements. They are an integral part of your compliance structure and must reflect the requirements of the Medical Device Regulation (MDR), the Medical Device Law Implementation Act (MPDG), ISO 13485 and, where applicable, FDA regulations in a legally compliant manner. The regulatory requirements for medical devices have increased considerably in recent years. When the MDR came into force on May 26, 2021, the obligations for all economic operators along the supply chain were redefined and tightened. Article 10 MDR in particular requires manufacturers to establish and maintain a documented quality management system, which also includes the contractual management of all outsourced processes and supplier relationships.

Our contract management translates regulatory requirements into practicable, audit-proof and resilient agreements that clearly define responsibilities and strengthen your compliance structure in the long term.

Every contract in the medical device sector must ensure that all parties involved can fulfill their legal and normative obligations. We draw up and review contracts taking into account the specific requirements of your product, your risk class and your market region. We systematically take into account the requirements of MDR Article 10 (QMS requirements), ISO 13485 (quality management) and ISO 14971 (risk management) in order to translate regulatory and technical requirements into clear contractual obligations, documentation requirements and escalation paths.

A key benefit of our legal manufacturer perspective is that we ensure consistency between your contracts, your quality management system and your technical documentation. Contracts that are developed in isolation from the QMS often lead to inconsistencies that become problematic in audits. We ensure that contractual agreements are seamlessly integrated into your existing processes and that audit trails are fully traceable. This significantly reduces regulatory risks such as deviations during audits by notified bodies and creates clear responsibilities that facilitate audits.

Our contracts precisely define which party is responsible for which aspects of product safety, vigilance and post-market surveillance. This is particularly important in complex supply chains or OEM-PLM constellations, where the MDR imposes significantly stricter requirements than the previous MDD. We also take into account liability aspects and product liability risks, which will become even more relevant from December 2026 due to the new Product Liability Directive (EU) 2024/2853.

Supplier contracts in the MedTech sector are subject to special requirements, as suppliers have a direct influence on product quality and therefore on patient safety. The MDR requires manufacturers to carry out a risk-based assessment and qualification of their suppliers as well as complete documentation of these processes. Quality assurance agreements (QAAs) are central components of the quality management system in accordance with MDR and ISO 13485.

We design and review quality assurance agreements that contain all the elements required by regulations: Product quality requirements, test procedures and acceptance criteria, documentation obligations and change management, audit rights and monitoring mechanisms, traceability in accordance with Article 25 MDR as well as regulations on supplier evaluation and re-evaluation. Particularly important is the consideration of Article 120 (3) MDR, which places specific requirements on contracts with economic operators that have to be implemented since May 2021.

Our quality assurance agreements are designed to be MDR-compliant and can be seamlessly integrated into your existing QM system. We support you in risk-based supplier selection in accordance with ISO 14971 and define clear processes for monitoring and re-evaluating suppliers in the contract. If desired, we can assume overall responsibility as a legal manufacturer and ensure that your supplier contracts fully reflect the regulatory chain of responsibility. This is particularly relevant if critical product components or processes are outsourced or if suppliers themselves do not have ISO 13485 certification.

Clinical trials are required much more frequently under the MDR than under the previous MDD, particularly for products in risk class III and implantable devices. The contractual design of clinical trial agreements, CRO service contracts and subcontractor agreements is complex and requires precise regulations on responsibilities and regulatory obligations.

Contracts are not static documents. They must be regularly reviewed and adapted to new regulatory requirements, updated standards and changes to internal processes. MDR updates, new MDCG guidelines, changes in harmonized standards or QMS adjustments may require contract amendments. Systematic contract management is therefore essential for audit and inspection capability and contributes to continuous compliance throughout the entire product life cycle.

We organize a structured contract register with compliance relevance for you that links contracts with products, processes and risk assessments. This register enables you to track which contractual regulations apply to which products at any time, when contracts expire and where action is required.

Our contract management combines regulatory expertise with practical implementation experience as a legal manufacturer. We not only understand the requirements of the MDR, ISO 13485 and other relevant regulations in theory, but also live them every day in our own responsibility for medical devices. This unique perspective enables us to draft contracts that are not only formally correct, but also work in everyday operations and can be lived by all parties involved.

Our range of services includes the conception, creation and review of all contract-relevant documents in the MedTech sector. We structure complex contractual landscapes for supply chains, OEM-PLM constellations or international distribution structures. We assist you in contract negotiations with suppliers, CROs or sales partners and ensure that minimum regulatory requirements are met. If desired, we can assume overall responsibility as a legal manufacturer and act as a contracting party ourselves if this is advantageous for your market strategy or compliance structure.

Our support in integrating contract management into your existing systems is particularly valuable. We link contracts with your QMS, your risk management documentation and your technical documentation so that consistent and seamless verification is possible. This integrated approach minimizes audit risks and creates the basis for sustainable compliance that will also withstand future regulatory changes.

Would you like to make your contract landscape MDR-compliant, have existing contracts checked for compliance or need support with complex contract negotiations? Contact us for a non-binding consultation. We will analyse your specific situation and work with you to develop a solution that minimizes your regulatory risks and strengthens your compliance structure in the long term.