The MDR for medical devices (EU Regulation 2017/745) continues to pose significant challenges for manufacturers in 2025 and the upcoming 2026. From clinical evidence to post-market surveillance, from new integrations with the AI Act to contractual obligations, understanding the legal implications of MDR is essential to operate in compliance within the European market, especially with critical regulatory deadlines approaching.
Clinical evidence under MDR: requirements and complexity
One of the core pillars of the MDR is the demonstration of clinical evidence, a complex process that began in 2017 and will conclude in 2028. As the final deadline approaches, 2026 becomes a crucial year for manufacturers who must complete data collection. The process is further complicated by the application of the GDPR, which strictly regulates the use of sensitive data.
In 2025, the regulatory landscape evolved with the introduction of the AI Act (EU Regulation 2024/1689), which adds new obligations for AI-powered medical devices. The MDCG 2025-6 guidelines ((Interaction between the Medical Devices Regulation, the In Vitro Diagnostic Medical Devices Regulation and the AI Act) clarify how MDR, IVDR and the AI Act apply together. This framework will be fully operational in 2026 and requires cross-functional expertise between medical regulation and digital technologies.
Post-market surveillance and Article 10a of the MDR
Post-market surveillance (PMS) and post-market clinical follow-up (PMCF) are essential to ensure the continued safety of medical devices. Manufacturers must constantly analyze post-marketing data to remain compliant, improve safety and detect risks early.
Article 10a of the MDR, in force since January 10, 2025, introduces a significant new requirement: manufacturers must notify the interruption of supply at least six months in advance to:
- Competent authorities and economic operators
• End users and healthcare facilities
• Distributors and procurement bodies
Unless justified by exceptional events (e.g. natural disasters), failure to notify may result in breach of contract and serious legal consequences. Unplanned production stops can disrupt healthcare services and expose distributors to significant risk.
MDR and medical software: digital responsibilities
The MDCG 2025-4 guidelines clarify the roles of digital platforms (like app stores and marketplaces) that distribute software classified as medical devices. These platforms may be considered distributors or importers depending on their involvement in the supply chain.
It is essential to distinguish CE-marked medical apps from general wellness or fitness apps to ensure proper application of MDR and legal responsibilities in case of malfunction.
Contracts between manufacturers and distributors
The contractual relationship between manufacturers and distributors is often overlooked. Many agreements are informal, which increases legal vulnerability in case of regulatory changes or product recalls.
Clear and formal contracts should define:
- Information obligations and procedures for non-compliance
• Responsibilities for recalls or safety notices
• Management of regulatory updates (labelling, IFUs, etc.)
• Supply interruption procedures, as required by Article 10a
Well-structured agreements protect both parties and ensure continuity even in challenging situations.
Changes in the Italian healthcare system
The Italian healthcare sector is undergoing a transformation that also affects the market for MDR-compliant medical devices. According to the 2025 CNEL Report, private healthcare spending reached €42.6 billion (25% of total health expenditure), up 2% from the previous year.
In 2024, 10% of residents skipped specialist visits due to waiting lists or financial difficulties, while 23.9% paid entirely out of pocket, without insurance reimbursements. The ongoing shift towards a mixed public-private model calls for differentiated strategies for public and private providers.
Technical communication makes the difference
MDR compliance is not just about technical and legal aspects. Manufacturers must also ensure that documentation is accurate, clear and compliant across all languages and formats. From instructions for use to safety summaries, every document must meet regulatory and linguistic standards.
Choosing specialized language partners like Aglatech14 helps ensure accuracy, consistency and compliance across international markets. The company’s expertise covers medical device documentation, software localization, manuals, apps and multilingual marketing materials.
Conclusion: MDR medical device compliance
Complying with the MDR requires an integrated approach that combines technical, clinical, legal and contractual elements. The changes introduced in 2025, such as Article 10a and the AI Act, along with the 2026 deadlines, make it essential to keep regulatory strategies updated.
Investing in structured contracts, effective post-market surveillance and precise multilingual communication will be key to successfully operating in the European medical device market over the coming years.
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