Latest Posts:
Search for:
Category

Medical Devices

Category
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,…

Read More
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…

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 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…

Read More
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…

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 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…

Read More
In Medical Devices

The European Commission launches an investigation into Chinese public procurement of medical devices

by 4 Mins Read

On 24 April 2024, the European Commission announced the launch of a formal investigation into the measures put in place and practices followed by China in its public procurement of medical devices. The announcement responds to the Commission’s belief that these measures and practices favour domestic Chinese suppliers whilst putting EU companies at a clear disadvantage. The investigation will be carried out under the EU’s International Procurement Instrument (IPI), a trade tool that aims to…

Read More
In Medical Devices

New Emirates Drug Corporation Soon to be Operational Replacing MOHAP as Federal Regulator of all Medical Products

by and 4 Mins Read

To future-proof its regulatory system, the UAE cabinet has established the Emirates Drug Corporation (EDC) in September 20231. As a new independent regulator, the EDC will replace the Ministry of Health and Prevention (MOHAP) for the regulation of pharmaceuticals and medical devices. Besides medicines and medical devices the EDC will also be responsible for cosmetics, dietary supplements, GMOs, fertilizers, pesticides, agricultural conditioners and plant growth regulators. The EDC will also take over some competences from the Ministry of Climate Change and Environment…

Read More
In Medical Devices

The New EU Corporate Sustainability Due Diligence Directive Has Been Provisionally Agreed, What Does This Mean for H&LS Companies?

by , and 1 Min Read

The Corporate Sustainability Due Diligence Directive (“CS3D”), provisionally agreed in December 2023, will create significant behavioural and reporting obligations for many EU and non-EU healthcare and life sciences companies active in the EU, adding an additional layer of compliance and complexity to their already highly intricateglobal value chains. In this first instalment of our new “CS3D Explainer Series”, we provide an overview of scope, key obligations and relevant timeline under the CS3D.

Read More