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Jaspreet Takhar

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In Medical Devices

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

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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 Health Data Privacy & Security

SRB Is Not a Shortcut to Anonymity: What Recent CNIL and Garante Decisions Mean for Health Data in the EU

by and 6 Mins Read

Remove the names. Replace them with codes. Place the key with a third party. Anonymous data? Not necessarily. Recent decisions by the Garante and the CNIL are clear reminders that key-coded health data does not automatically fall outside of data protection law. Although SRB offers a potential route to treating pseudonymised data as anonymous in the hands of a particular recipient, it is not a silver bullet. Pharmaceutical and medtech businesses must still address re-identification…

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In Digital Health

Medical Device AI in Limbo: EU’s Digital Overhaul or Digital Headache for Pharma and Medtech?

by and 10 Mins Read

The EU ended 2025 with a legislative blitz – AI, cybersecurity, data use, data protection, and medical devices were all subject to proposals promising to shake-up the status quo. On paper, it looks like progress: extended grace periods for high-risk AI, lighter admin under the AI Act, and clearer personal data rules. But scratch the surface, and the story changes. Coordination between proposals? Missing. Clarity? Questionable. And the biggest headache? Conflicting proposals on whether medical…

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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

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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In Pharmaceuticals & Biotech

External Control Arms Based on Real World Data: MHRA Consultation Opens

by , and 2 Mins Read

On International Clinical Trials Day, the UK’s MHRA unveiled a major shift: a consultation on using external control arms (ECAs) based on real-world data (RWD) for regulatory decisions. This move aims to leverage patient-level data collected outside clinical studies to compare the efficacy and safety of interventions in clinical trials. Stakeholders have until the end of June to weigh in. What’s the Focus? The guidelines target sponsors planning to use RWD ECAs in trials needing…

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In Medical Devices

The EU AI Act and Medical Devices: Innovation or Insanity Ahead? 

by , and 6 Mins Read

AI as a medical device (AIaMD) in Europe is at a crossroads. As manufacturers grapple with compliance under two separate legal regimes – the EU AI Act (AIA) and EU Medical Device Regulations (MDR) – concerns are mounting around the sluggish pace of Notified Body designations and glaring inconsistencies between the two frameworks. Can the EU stay competitive when the AIA is piling on more regulatory obstacles than ever before? In our blog post, we…

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In Health Data Privacy & Security

European Health Data Space Regulation Published – What’s Next?

by , and 8 Mins Read

On 5th March 2025, the European Health Data Space (EHDS) Regulation was officially published in the Official Journal of the European Union. The EHDS enters into force on 26 March 2025 – this is the beginning of the transition phase towards application. At its core, the EHDS is about three things: (1) empowering patients with new health data rights (primary use); (2) a new pathway to access electronic health data for research and innovation (secondary…

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