Latest Posts:
Search for:
Tag

EU

Browsing
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…

Read More
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…

Read More
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…

Read More
In Pharmaceuticals & Biotech

EU and German Courts Clarify Rules on Rx Drug Discounts in latest DocMorris decisions

by , and 7 Mins Read

With its ruling in Apothekerkammer Nordrhein v. DocMorris (Case C-517/23), the Court of Justice of the European Union (CJEU) provided further clarity on the interpretation of EU law concerning the advertising of medicinal products, with a particular emphasis on prescription-only (Rx) medicinal products. Most importantly, the CJEU ruled that advertising unspecified Rx medicinal products by offering price reductions (cash discounts) and payments falls outside the EU law concept of medicinal product advertising. Recently, in a…

Read More
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…

Read More
In Medical Devices

European Commission Proposes Act to Secure Critical Medicines Supply but has Wider Ambitions for Improved Accessibility of Other Medicinal products by Creating a Framework for Collaborative Procurement

by , and 6 Mins Read

On 11 March 2025, the European Commission published the Proposal for a Critical Medicines Act 1, a new Regulation aimed at improving the availability of critical medicines in the European Union. The Proposal has however a wider scope and seeks to introduce collaborative procurement mechanisms and information sharing obligations not only for critical medicines but also medicines which are considered of common interest. 1. Securing Supply of Critical Medicines According to European Health Ministers Europe…

Read More
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…

Read More
In Digital Health

EHDS Deep-Dive: EHR systems, wellness apps and medical devices (Part 4)

by , and 6 Mins Read

After months in the pipeline, it looks like the European Health Data Space (EHDS) is finally entering into force later this year. But what does this mean for your organisation? This is the fourth post in our EHDS series. In this post, we focus on the new product regime for electronic health record (EHR) systems, including the impact on wellness apps, AI systems and medical devices. We examine the latest publicly available draft, dated 24…

Read More
In Pharmaceuticals & Biotech

ECJ Ruling: Pharma Payments to State Health Insurers Are Rebates, Not Taxes

by , and 2 Mins Read

Pharmaceutical companies can breathe a sigh of relief following the European Court of Justice’s recent ruling in the Novo Nordisk A/S case (C-248/23 ). This decision marks the third time the ECJ has softened the rules around deducting pharmaceutical subsidies from the VAT base. Previously, in the German and Hungarian Boehringer cases (C-462/16 and C-717/19), the ECJ allowed subsidies to be deducted if paid to private insurers and later extended this to public insurers under…

Read More
In Digital Health

EHDS Deep-Dive: New pathway for accessing health data (Part 3)

by , and 11 Mins Read

After months in the pipeline, it looks like the European Health Data Space (EHDS) is finally entering into force later this year. But what does this mean for your organisation? This is the third post in our EHDS series. In this post, we focus on the change that has been generating all the headlines: a new pathway to access health data for secondary uses like research and innovation. We examine the impact of this pathway…

Read More