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Medical Devices

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In Digital Health

Germany’s implementation of the European Accessibility Act (EAA) – Are medical devices affected?

by 1 Min Read

The German Accessibility Strengthening Act (BFSG), implementing the European Accessibility Act Directive (EU 2019/882), takes effect on June 28, 2025. While medical devices themselves are not within the scope as a product category, accessibility requirements may still apply where medical device software operates on EAA-covered hardware (e.g., smartphones, tablets). E-commerce services, including webshops selling medical devices directly to patients, must also be EAA-compliant. Certain components of medical or healthcare apps, particularly account creation and registration…

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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 Medical Devices

US Tariffs and the Life Science industry – an update

by , , and 4 Mins Read

Following our previous post here, we provide an update on the current developments in this area. On April 2, 2025, the US administration announced reciprocal tariffs on all imports into the United States (see here). As it has been widely reported, pharmaceutical products were exempted from these tariffs whereas medical devices were not. Subsequently, on April 9, 2025, the administration announced a 90-day postponement of the reciprocal tariffs for most countries except for China. For…

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In Digital Health

The Healthcare Agenda of Germany’s New CDU/SPD Coalition Government – A Point-by-Point Analysis of Key Policies and Their Potential Implications for Pharma and Med-Tech Companies

by and 11 Mins Read

In brief The newly negotiated Coalition Agreement between Germany’s center-right CDU and center-left SPD political parties outlines a healthcare policy agenda with implications for pharma and med-tech companies. Key measures include reinforcing general practitioners as gatekeepers, expanding Hybrid-DRG hospital reimbursement aiming to shift care to outpatient settings, and reintroducing prompt payment “Skonto” discounts for Rx drugs granted to pharmacies. HTA (AMNOG) pricing rules will be maintained, though “guardrails” limiting reimbursement prices may possibly be reconsidered,…

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In Medical Devices

Switzerland’s Therapeutic Products Act Revision: Industry Stakeholders Show Positive Support

by , and 7 Mins Read

I. Overview of proposed key changes The Swiss Federal Act on Medicinal Products and Medical Devices (Swiss Therapeutic Products Act, TPA), which has been in force since 2002, is currently undergoing its third revision. The proposed changes are designed to improve the safety and quality of medicinal products and medical devices (therapeutic products). The changes will update the legal framework to match current scientific and technological standards, as well as international laws, especially those…

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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…

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In Medical Devices

The Impact of Tariffs on the Life Sciences Industry

by , , and 9 Mins Read

Import tariffs have become the priority trade issue since President Donald Trump took office on January 20, 2025, with a wide variety of measures announced and imposed. These tariffs have the potential to disrupt all industries; however, they pose unique challenges for the life sciences industry, in particular the pharmaceutical and medtech industry, whose products have typically not been subject to customs duty on cross-border movements. We have set out below i) a summary of…

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In Medical Devices

The French Political Crisis Leads the Pharmaceutical and Medical Device Industries Towards A Leap Into the Unknown for 2025

by , and 2 Mins Read

On 5 December 2024, the French Government was forced to resign following the vote of non-confidence by the French National Assembly towards the Social Security Financing Bill (“PLFSS”). A new Government was then appointed on 23 December 2024. As a result, 2024 ended without a PLFSS for 2025, leaving the Pharma and MedTech industries in uncertainty, particularly regarding the safeguard clause mechanism.   A Special Law To Prevent From Any Shutdown The PLFSS is debated…

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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…

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In Medical Devices

UK MHRA’s International Recognition for Medical Devices

by , and 3 Mins Read

The UK’s MHRA has published a statement of policy intent for recognition of international regulators’ approvals of medical devices in Great Britain (GB). If your organisation’s medical device is authorised in any of Australia, Canada, the EU, or USA (together, Comparable Regulator Countries or CRCs), you may be able to leverage this to gain fast-tracked access to the GB market. This means that manufacturers may be able to side-step the full UK authorisation process for…

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