Articles for the ‘General’ Category
Webinar: The interplay of the Medical Device Regulation, AI and data protection in medical technology
Published 28 May 2024 by Dr. Oliver Stöckel
SKW Schwarz, Germany
In the dynamic world of medical technology, it is essential to always be aware of the latest regulatory requirements. The introduction of the AI Act poses new legal challenges for medtech companies when using AI.
In addition, the requirements of the MDR and data protection must still be complied with, particularly with regard to the handling of sensitive health data. But how exactly does the “magic triangle” of MDR, AI Act and data protection work in medical technology?
Using practical examples we will answer this question and would like to invite you to our free webinar (in German language):
“The interplay of the Medical Device Regulation, AI and data protection in medical technology”
on Thursday, June 13, 2024
from 12:30 – 13:30
via MS Teams
Register for free today and benefit from our in-depth knowledge and expertise in the field of digital health: to the registration
... Read moreForthcoming changes to the public health insurance system in the Czech Republic: what you need to know
Published 03 May 2024 by Kateřina Slavíková
HAVEL & PARTNERS | Czech Republic, Czech Republic
As with many healthcare systems worldwide, the Czech Republic faces challenges regarding sustainable funding and escalating healthcare costs, particularly concerning chronic and rare diseases.
Aiming to address emerging needs in public healthcare, on 12 April 2024, the Ministry of Health of the Czech Republic introduced a draft amendment to the Act on Public Health Insurance and other related laws, which is proposed to take effect on 1 January 2026. In this article, we provide an overview of the key areas affected by the legislative proposal, namely (i) price and reimbursement regulation of medicinal products and medical devices, (ii) preventive care support, (iii) reimbursement of cross-border healthcare services, and (iv) dental care reimbursement.
... Read more
Changes in the law on marketing of veterinary medicines: what you need to know
Published 06 February 2024 by Christophe Ronse
ALTIUS Lawyers, Belgium
Belgium is welcoming a significant development in the field of veterinary medicine law. The Act of 11 July 2023 containing various provisions on health, which entered into force on 8 September 2023, introduces changes across a wide spectrum of healthcare domains, which are encompassed in approximately 20 chapters. In this blog post, we provide an overview of the key changes related to the marketing of veterinary medicines set out in Chapters 4 and 14 of the new Law.
... Read more
The advertising of medical devices in Austria
Published 05 February 2024 by Francine Brogyányi
DORDA Rechtsanwälte GmbH, Austria
In every jurisdiction the advertising of medical devices comes with certain national peculiarities. The following article explains in more detail what needs to be considered if you intend to market medical devices to the Austrian market
... Read moreThe Court of Justice’s New Ruling – Finnish Strict Liability Regime regarding Unfounded Preliminary Injunctions Compatible with the EU Enforcement Directive
Published 01 February 2024 by Ben Rapinoja
Borenius Attorneys Ltd, Finland
The Court of Justice of the European Union (the “Court of Justice”) handed down its judgment in case C‑473/22 (Mylan v. Gilead and Others) at the beginning of January 2024. The case concerned the Finnish compensation regime that can be invoked when a preliminary injunction is found to have been unfounded. This compensation regime is based on the concept of strict liability.
Although the judgment primarily concerns compensation claims subject to the Finnish law, the judgment has implications in all EU jurisdictions where a similar strict liability regime exists. The Court of Justice’s judgment provides clarity for cases where an intellectual property right is first used to justify a preliminary injunction and then subsequently found invalid.