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Drafting PMS and vigilance obligations into medical device distribution agreements
In this article we discuss here how manufacturers might ensure, through appropriate contractual provisions, that distributors (and importers) will provide all necessary support to allow a manufacturer to comply with its PMS obligations.
6 of 6 Insights
Product Liability Directive: Are you ready for its Article 9 disclosure obligations?
The New EU Directive on Liability for Defective Products modernises the current EU legislation to bring it up to date with our ever-evolving digital environment. One particularly significant change is the extended disclosure burden. In this article we examine why this burden is particularly difficult for multi-national life sciences businesses and explain the steps you should be taking now to mitigate against potential court sanctions for failure to disclose relevant evidence.
3 of 6 Insights
A new era for product liability in the EU
This article outlines the key changes introduced by the new PLD. It explores the expanded scope of liability and the broader pool of potentially liable parties, as well as the new rules on the burden of proof and disclosure of evidence.
1 of 6 Insights
German Environment Agency (Umweltbundesamt, UBA) prohibits German long-distance bus company from advertising in Belgium with the terms “climate-friendly” and “environmentally neutral”
The EU Urban Wastewater Treatment Directive
New Legal Framework for the Commercial Use of Carbon Capture and Storage (CCS) and Carbon Capture and Utilisation (CCU)
#6: FIDA Regulation: Overview of the Open Finance Framework from the legal and practical perspective
In this episode, we dive into the Financial Data Access (FIDA) Regulation and explore what it means for Open Finance in the EU.
Court Rulings on Pharmacy Marketing Remain Strict: OLG Frankfurt Prohibits Voucher Advertising
Recruitment for the new era (Part I): Avoiding criminal law risks when using external experts
Training of AI models with user data - Decision of the Higher Regional Court of Cologne in the Meta case
Accelerated Bundeswehr Procurement 2.0
Higher Regional Court of Frankfurt am Main on online referral of doctors for the prescription of medical cannabis