Introduction
The year 2025 marked a defining moment for the European MedTech sector — a time when the regulatory framework, digital transformation and rapid technological innovation converged with unprecedented intensity. Changes long anticipated finally took concrete form: medical software received clear rules for making applications available on digital platforms, the IVDR saw its most comprehensive clarifications since entering into force, and biological safety requirements were redefined through the updated ISO 10993 standard. At the same time, the field of clinical research underwent its most significant transformation in two decades with the publication and progressive implementation of GCP R3, enabling full integration of Quality by Design, decentralised clinical trials (DCTs) and digital data sources.
2025 was a year of fundamental change, prompting reflection and structural adjustment across hundreds of companies. It also offered a clear vision of the future — one that is increasingly digital, risk-based, and far more structured from a regulatory standpoint. For anyone seeking to understand where the European MedTech sector is headed, an analysis of this year is essential.
2025: A review of the key regulatory developments affecting the MedTech Sector
The year 2025 was characterised by the publication of numerous new documents, updates and interpretative notes that reshaped how the industry operates in practice. The most significant changes affected medical software, IVD performance evaluation, biological safety and clinical research.
Overview of Key Regulatory Documents (2025)
| Area | Key Document | Relevance for the Market |
| Software | MDCG 2025-4 | New rules for publishing and distributing MDSW on online platforms |
| Software Qualification | MDCG 2019-11 rev.1 | Updated classification rules (including Rule 11, modularity) |
| IVD | MDCG 2025-5 | Comprehensive Q&A on performance studies, including CDx |
| MDR | OJ L 2025 | Clarification of definitions, operator obligations and alignment with other acts |
| Biocompatibility | ISO 10993:2025 | New chemical–toxicological approach and revised risk analysis |
| Clinical Trials | GCP R3 | Modernised approach to quality, digitalisation and decentralised trials |
| CTA in Switzerland | Swissmedic BW101_10_004 | Updated procedures and dossier structure for clinical trial submissions |
Medical Software on Digital Platforms: MDCG 2025-4
One of the most influential documents of 2025 was MDCG 2025-4, which for the first time provided detailed guidance on making medical device software available on digital platforms such as mobile application stores. The document clarified the distinction between intermediary service providers, distributors and importers, while linking these roles to the obligations arising from the Digital Services Act. As a result, operators of app platforms are now responsible for verifying manufacturers, ensuring transparent product categorisation and removing illegal or non-compliant devices. This long-awaited guidance fills a critical regulatory gap and directly impacts the distribution chain for MDSW.
Software under the microscope: Update of MDCG 2019-11 rev.1
Another pivotal development was the updated MDCG 2019-11 rev.1 guidance on the qualification and classification of medical device software. The revision refined the interpretation of MDR Rule 11, expanded considerations for modular software architectures and provided clarity on software involving artificial intelligence, electronic health record (EHR) systems and predictive functionalities. The document reinforced the importance of a clearly defined intended purpose, which forms the foundation for correct qualification and regulatory strategy planning.
Performance Studies under the IVDR: MDCG 2025-5 Q&A
In the IVD sector, the most impactful document was MDCG 2025-5 — an extensive Q&A covering performance studies. The guidance clarified the distinction between analytical and clinical performance studies, outlined rules for using leftover samples and provided authoritative interpretations of Articles 57, 58 and 70 IVDR. These clarifications were essential for manufacturers facing persistent uncertainty regarding interventional performance studies, companion diagnostics and the evidence required to demonstrate compliance with the General Safety and Performance Requirements (GSPR).
IVD performance studies clarified: MDCG 2025-5 answers 50 frequently asked questions
New publications in the Official Journal of the EU
Additional clarity was provided through new publications in the Official Journal (OJ L), which further refined MDR requirements, including key definitions related to making devices available, obligations of economic operators and the interplay between MDR and other legal frameworks. Although technical in nature, these updates had a substantial impact on daily regulatory practice.
The Updated ISO 10993 Standard — The future of biological safety
A major milestone of 2025 was the publication of the revised ISO 10993 standard, introducing a far more advanced chemical-toxicological approach to biological evaluation. The update emphasised comprehensive chemical characterisation, reduced reliance on in vivo testing and full integration of biocompatibility assessment within a device-specific risk management framework. These changes particularly affect manufacturers of implants and long-term invasive devices, who must now revise their technical documentation and toxicological strategies accordingly.
ISO 10993-1:2025 – new foundations for biological evaluation under the MDR
Clinical Research in the digital era — GCP R3 as the new quality standard
Another dominant theme of 2025 was the release and initial implementation of GCP R3, ushering in a new era of clinical research. The updated guideline modernised requirements for trial design, monitoring and data management. At its core lies the Quality by Design concept, which requires critical-to-quality factors to be identified at the earliest stages of protocol development, ensuring quality is built into the trial from the outset.
For the first time, GCP R3 formally recognised decentralised clinical trials as equivalent to traditional site-based studies. This breakthrough enables the broader use of telemedicine solutions, wearable medical devices, automatically generated device data, ePRO, eConsent and integrated eSource systems — an especially significant shift for manufacturers of medical devices and MDSW relying on remote data acquisition.
GCP R3 also advanced risk-based quality management, making it more data-driven and statistically aligned. Trial monitoring is now moving away from routine visit-based approaches toward signal-driven, analytical and risk-adjusted oversight. The guideline additionally offers more flexibility with respect to documentation — a welcome development for studies involving complex digital components. Many organisations began preparing for R3 implementation in 2025, with 2026 expected to solidify R3 as an operational standard.
EUDAMED — Closer to full functionality
EUDAMED continued to expand in 2025, with additional modules entering production status. Device registration and UDI, vigilance features and integrated data on notified bodies and certificates began to meaningfully influence market surveillance. Improvements in interoperability have made the system more practical for manufacturers preparing documentation in accordance with MDR. The year 2026 is expected to mark the transition from optional to mandatory use of the system for all economic operators.
EUDAMED approaches full operational Status: New duties for EU Economic Operators
What does 2025 reveal about the future of MedTech?
The year 2025 demonstrated the maturity and adaptability of the European MedTech ecosystem. Regulatory change has become a tool enabling innovation, rather than merely a market access barrier. For companies that understood the direction of transformation, 2025 provided a decisive advantage — one that will become increasingly visible in 2026. Clearer software guidance, a more coherent framework for IVD performance evaluation, a modernised approach to biocompatibility and a comprehensive update of GCP collectively strengthen the foundations for safe, intelligent and future-ready medical technologies.
The MedTech sector has never been as dynamic — nor as consciously regulated — as it is today. We are entering an era in which competitive advantage stems not only from technological advancement but also from the ability to implement it safely and compliantly. The year 2026 will undoubtedly continue this regulatory evolution.
What will 2026 bring?
Based on the developments of 2025, the year ahead will see a continued intensification of regulatory activity, particularly in the areas of artificial intelligence and cybersecurity. The AI Act will redefine requirements for predictive and decision-support software, while new cybersecurity standards will apply both to connected medical devices and algorithms processing real-time patient data. Full operational deployment of EUDAMED is anticipated, as is the widespread adoption of decentralised clinical trials aligned with GCP R3. The updated ISO 10993 standard will become the primary reference point for evaluating the biocompatibility of implantable and long-term devices, prompting manufacturers to revise their technical documentation accordingly.