Impact on medical devices and IVD
Biotechnology can pave the way for groundbreaking medicines and treatment options. At the same time, its scientific findings form the basis for innovative medical devices and in vitro diagnostic medical devices (IVD), particularly in the fields of gene therapy, personalised medicine and biopharmaceuticals, and can thus drive innovation in the healthcare products market.
A new regulatory framework for biotechnology
With the draft European Biotech Act, the EU is addressing the entire value chain of biotechnology products. The aim is to streamline the process from the laboratory through production to market launch, without compromising on the high safety standards designed to protect the public and the environment. The proposed legislation focuses in particular on health biotechnology but also contains provisions relating to food and feed. Following the Commission’s presentation of its draft regulation back in 2025, the European Parliament’s Committee on Legal Affairs has now published its opinion on the proposed legislation in September 2026.
The Regulation is intended to apply to innovations and products in the field of health biotechnology, as well as their ecosystem, throughout their entire life cycle, including related activities in the areas of research, funding, development, innovation, testing, validation, manufacture, placing on the market and use. For the first time, it is also intended to specifically address so-called biotechnology products. According to the new legal definition, a biotechnology product is any good, technology or activity resulting from the application of biotechnology, including all processes, measures, techniques, tools or knowledge that involve biotechnology. Biotechnology, in turn, is defined as the application of science and technology to living organisms, as well as their parts, products and models, in order to modify living or non-living materials for the purpose of gaining insights, producing goods and providing services.
European Biotech Act – Overview of Chapters
- Fundamentals
Subject matter, scope of application & definitions - Strategic Projects
Recognition, support and coordination of biotechnology projects - Investments
EU pilot project to mobilise private investment - Protection Certificate
Extension of supplementary protection certificates for biotech and ATMPs - Biosimilars
Greater competition, achieved, amongst other things, through a simplified authorisation process - Artificial Intelligence
The use of AI in biotechnology - Procedures
Support for companies with regard to regulatory procedures (taking into account MDR/IVDR) - Prevention of abuse
Suspicious Transactions & Enforcement - EU legal framework
Simplification & accelerated time-to-market
Impact on medical devices and IVD
A key focus of the Biotech Act is on simplifying, streamlining and accelerating clinical trials in accordance with Regulation (EU) No 536/2014 (Regulation on clinical trials on medicinal products for human use). In particular, the authorisation periods for multinational clinical trials are to be reduced from 75 to 47 days, and in the case of supplementary information requests, from 106 to 76 days. The assessment periods for substantial amendments are also set to be significantly reduced.
The changes in the Biotech Act relevant to medical devices and IVD primarily concern this interface with clinical trials of medicinal products. The amendments to Regulation (EU) No 536/2014 are intended to shorten the authorisation procedures for multinational clinical trials and for substantial amendments, and to harmonise them more closely overall. This is particularly significant for manufacturers and sponsors of medical devices and IVD when their products are being investigated in conjunction with a medicinal product as part of a single clinical development programme.
A key element is the planned introduction of so-called combined studies, which may be submitted or considered as part of the conformity assessment of medical devices or IVD. In such cases, the sponsor should in future be able to submit a single application for authorisation, provided that the clinical trial under the MDR or the performance study under the IVDR is subject to authorisation. This is intended to ensure that previously separate regulatory procedures are better coordinated, to avoid duplicate assessments and to facilitate the implementation of complex development projects.
In addition, accelerated and simplified procedures are to be established for multinational clinical trials in public health emergencies. This may be particularly relevant for medical devices and IVD that are developed in conjunction with medicinal products for the diagnosis, monitoring or treatment of novel health threats. The Biotech Act therefore does not primarily amend the fundamental substantive requirements of the MDR and IVDR, but rather simplifies, above all, the procedural integration of medicinal product trials, clinical trials and performance studies.
AI in the European Biotech Act
According to the draft regulation, regulatory real-world laboratories and trusted testing environments are to be established in which innovative, AI-supported approaches can be developed, tested and validated under controlled conditions. To this end, the EMA, in agreement with the Commission and in consultation with the AI Office, is also to publish guidelines on the use of advanced technologies, including AI, throughout the entire life cycle of medicinal products. These guidelines will cover, in particular, pre-clinical research, clinical development and clinical trials, manufacturing, and post-authorisation monitoring. The guidelines are to be updated regularly and formulated in line with the requirements of the AI Act and the guidelines issued in this regard. In addition, the Biotech Act provides for the funding of so-called ‘data quality accelerators’. These are specially funded projects designed to prepare and provide high-quality, annotated, interoperable and verifiably sourced datasets for the training, validation and testing of AI systems in health biotechnology.
Conclusion
The Biotech Act opens opportunities for manufacturers of medical devices and IVD, particularly where products are developed or tested in conjunction with medicinal products, or integrated into biotechnological care pathways. The introduction of combined studies and a single authorisation application allow the procedures under Regulation (EU) No 536/2014, the MDR and the IVDR to be efficiently integrated. This helps to reduce duplication and shorten development times. The substantive safety and performance requirements of the MDR and IVDR remain fundamentally unchanged; significant changes primarily concern the regulatory procedures and their coordination. Where AI is incorporated into medical devices, the relevant amendments in the Biotech Act and their interactions with the AI Act must be considered. Manufacturers should therefore take the new regulatory requirements into account now to capitalise on opportunities in the long term and minimise additional administrative burdens.
back