Entries by Eva von Mühlenen

16 10 '26

A More Competitive MedTech Landscape in the EU? What the MDR/IVDR Revision Could Mean for MedTech Manufacturers and Investors

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The EU’s targeted revision of the medical device and in vitro diagnostics framework has entered a more active phase, with nearly 800 amendments tabled in Parliament in July 2026 and the Council’s examination continuing in parallel. The revision would ease certification bottlenecks by removing the five-year cap on certificate validity, scaling notified body involvement to device risk, and letting lower-risk software move down to self-certified Class I. It would also loosen clinical evidence requirements, create fast-track pathways for orphan and breakthrough devices, and regulate AI-enabled devices primarily under the MDR/IVDR rather than the AI Act. This post summarizes the key aspects of the proposed revision, the prospects for their adoption, the issues still in play, and what manufacturers and investors should plan for.

21 09 '26

EU Biotech Act I: Parliament and Council back Europe’s biotech competitiveness agenda – SPC incentive now the key battleground

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Momentum is building behind the European Biotech Act I. The European Parliament and the Council of the EU broadly back the competitiveness agenda, with strong cross-party support for faster clinical trials, strategic-project funding, and regulatory simplification, and Member States showing less resistance than expected. The supplementary protection certificate (SPC) extension is the main open point – and the clearest test of how far Europe will go to attract biotechnology research, development, manufacturing, and investment.

The Commission presented its proposal in December 2025 (see our initial Sidley blog post here). This update focuses on how the package has evolved since then and what the latest developments in Parliament and the Council mean for biopharmaceutical developers and investors.

31 08 '26

Is my product a medical device? EU Court judgment clarifies that the test includes objective function and intended purpose, and provides guidance relevant to software and AI-enabled tools

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The recent judgment of the Court of Justice of the European Union (CJEU or the Court) in Case C-427/24, Diagramm Halbach clarifies the key principles for determining whether a product falls within the definition of a medical device and will be subject to the EU medical device regime. Crucially, the CJEU held that this analysis includes an assessment of both the manufacturer’s intended purpose of the product and whether the product objectively performs functions for a specific medical purpose listed in Article 2(1) of Regulation (EU) 2017/745, the Medical Devices Regulation (MDR).

11 06 '26

The EU AI Act’s Machinery Exemption: Does It Extend to Surgical Robotics?

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The EU’s latest AI reforms are intended to reduce regulatory duplication for products already subject to extensive sector-specific regulation. For manufacturers of surgical robotics, however, they leave unresolved how AI embedded within increasingly sophisticated surgical systems will be regulated in practice.

23 01 '24

Beyond Technology: Embracing Blockchain for a Paradigm Shift in Life Sciences

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Blockchain is not only the preserve of the fintech industry, but may have multiple uses for life sciences companies, including providing a consent structure for clinical trials to give enhanced patients more control over their own data. Sidley’s Eva von Mühlenen and Daniel Fritz, executive director of the PharmaLedger Association, explain.