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In Medical Devices

The EU AI Act’s First Harmonised Standard: What’s Next for Medical Device Manufacturers?

by and 3 Mins Read

The first harmonised standard under the EU AI Act has landed, giving medical device manufacturers a much clearer route through one part of the AI Act compliance puzzle. EN 18286:2026 addresses the quality management system (QMS) requirements for providers of high-risk AI systems. For medtech companies whose products fall within the AI Act’s high-risk regime, it provides a practical framework for translating the requirements of Article 17 into an operational QMS. More importantly, manufacturers do…

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In Data Privacy

The Next EHDS Implementation Wave: What Pharma and MedTech Need to Do Next

by and 6 Mins Read

The European Health Data Space (EHDS) is moving from framework to build phase, with several implementing regulations already adopted and a further wave of technical rules now in preparation. Many of these measures focus on the primary-use framework and will be most relevant to healthcare providers, Member States and electronic health record (EHR) system manufacturers. However, others are big news for businesses preparing for their new obligations as health data holders and health data users.…

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In Healthcare Services

United States: HHS-OIG Issues Unfavorable Advisory Opinion on Physician Royalty Arrangements with Device Company

by 5 Mins Read

In brief On May 18, 2026, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) released an unfavorable Advisory Opinion No. 26-10 (“AO 26-10”) addressing an arrangement proposed by an orthopedic medical technology company (the “Company”) that would compensate physician consultants (“HCPs”) through a percentage-of-sales royalty covering broad product lines (the “Arrangement”). OIG concluded that, while consulting and royalty arrangements are common in the medical device industry, this Arrangement presents a…

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In Medical Devices

EU Biotech Act Unveiled: Commission’s Proposal to Turn Europe into a Biotech Powerhouse

by 7 Mins Read

Background On 16 December 2025, the European Commission published its long-awaited Proposal for a Biotech Act with an aim to “build a world-leading health biotech industry” and transform Europe into a “Biotech Powerhouse”. The Proposal recognises that the EU is losing ground to global competitors such as the US and China in developing innovative biological products and identifies insufficient funding, regulatory bottlenecks, and barriers to innovation as key obstacles limiting the EU’s ability to compete…

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In Medical Devices

The EU’s 2025 proposal to simplify the Medical and In-Vitro-Diagnostic Devices Regulations (MDR/IVDR)

by and 16 Mins Read

On 16 December 2025, the European Commission published its proposal to simplify the EU’s Medical Devices Regulation (Regulation (EU) 2017/745) (MDR) and In Vitro Diagnostics Regulation (Regulation (EU) 2017/746) (IVDR). The proposal aims to simplify EU rules for the MedTech industry, support digitalization of regulatory procedures, harmonize divergent practices via strengthened cooperation, and speed up access by introducing timelines to complete conformity assessments. Finally, the proposal also intends to provide clarity on the rules applicable…

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In Medical Devices

Healthcare & Life Sciences Supply Chains Series: Opportunities for Innovators, Investors and Strategic Partners (4 of 4)

by , , , , , and 1 Min Read

Tariffs and shifting trade dynamics continue to disrupt healthcare and life sciences supply chains. But in addition to affecting operational and commercial outlooks for business, they are also revealing new opportunities for innovators and investors. In the final article of the series, we explore five key questions:

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In Medical Devices

Healthcare & Life Sciences Supply Chains Series: Achieving Stability Through Innovation and Compliance (3 of 4)

by , , , , and 1 Min Read

As supply chains shift and vendor arrangements evolve in response to tariffs, life sciences companies must adapt to increasingly intricate and intertwined challenges across operational and commercial needs. Manufacturing relocation, technology adoption, and new vendor partnerships require careful oversight of labor, compliance, human rights, and union matters. Protecting IP and data is vital against brand, legal, and cyber risks. Early IP registration, strong contracts, audits, and compliance help manage regulations and reduce Anti-Money Laundering (AML)…

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In Medical Devices

Medical Devices and In Vitro Diagnostic Regulations: Brussels Signals It’s Ready to Cut Red Tape?

by and 3 Mins Read

Brussels has finally blinked. On 8 September 2025, the European Commission launched a call for evidence to simplify the MDR and IVDR. The window is short — it closes on 6 October 2025, but the signal is clear: the Commission is ready to revisit rules that have become heavier than the risk they were meant to control. What’s on the table? The Commission wants to use this feedback to: Why now? This move sits alongside…

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In Medical Devices

Healthcare & Life Sciences Supply Chains Series: Trade Winds, Tariffs, and Optimizing Operations (2 of 4)

by , , , , , , , and 1 Min Read

Amid fluctuating tariffs and complex trade policies, healthcare and life sciences (HLS) companies face mounting operational and legal challenges within their global supply chains. Organizations are taking steps to retool their supply chains in response to threats against stability, but change introduces myriad knock-on implications. In the second article of the series, we explore four key questions for HLS businesses considering new supply chain strategies:

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In Medical Devices

The MHRA’s Summer Glow-Up: UK Medical Device Laws Get a Makeover

by , and 4 Mins Read

The MHRA didn’t take a summer break this year, so while we were packing our suitcases, the MHRA has been packing in the device reforms. We’ve set out a rundown of what’s new for medical devices in the UK. The main takeaways are: The details Enforcement is already happening. We’ve seen manufacturers navigating the new MORE portal (guidance here) and parsing fresh guidance on reportable incidents – including device-specific examples like Software as a Medical…

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