Medical and diagnostic products are part of our Life Sciences . We are aware that the MedTech sector is developing very quickly - which, combined with the development of digital technologies in health care, requirements regarding personal data protection and cybersecurity - means that market participants are faced with increasingly new legal challenges.
At IPSO Legal, we have the experience and knowledge thanks to which we can help clients solve many problems related to the development, protection and commercialization of medical devices and diagnostic devices. We understand the highly competitive nature of the medical device industry, the demands of investors and shareholders, and the importance of ensuring a strong intellectual property protection strategy early on.
At the same time, our experience in managing complex court processes makes it easier for us to prepare clients for even the most difficult court cases.
The new Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR) represent a long-awaited strengthening of the existing regulatory system for medical devices in Europe.
However, compliance is a real challenge for the MedTech industry in the coming years. Our team of regulatory experts stay up to date with these regulations and are ready to help companies meet this challenge.
As part of our regulatory practice, we deal with everything from issues related to product creation and its marketing authorization, to ensuring compliance with regulations after marketing and product life cycle management. We focus on risk management and navigating the complex regulatory environment while taking into account our clients' business goals.
Our services also include reviewing advertising campaigns and promotional materials, reporting adverse events, and import and export issues. We conduct assessment audits, develop recovery plans and assist in contacts with regulatory authorities. As a law firm with a holistic approach, we advise clients on compliance covering various areas of law, such as antitrust regulations, intellectual property and civil and criminal liability issues.