MDR/IVDR help point

Medical Devices Act

Answers to the most pressing questions about the new Medical Devices Act, MDR and IVDR.
Prepared and developed by specialists. Available with one click.

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    Legal support for the medical devices industry

    IPSO LEGAL is an excellent partner for all entities involved in the medical devices industry

    In the highly regulated medical device industry, it is critical that companies benefit from the knowledge and experience of legal advisors who know how to help them creatively implement their business strategies – in compliance with all rules and regulations.

    When advising clients in the medical device industry, we focus on transforming business goals into practical regulatory solutions, taking into account key quality issues. We support manufacturers, distributors, importers, responsible entities, as well as medical entities and other companies using medical devices and in vitro diagnostic medical devices in their activities.

    Our lawyers have extensive experience in supporting clients at every stage of a product's life and know the unique threats and challenges facing the medical device industry in connection with the application of the MDR and IVDR regulations and the Medical Devices Act.

    Many of our clients often complain about the level of legal regulations regarding running a business in the medical devices industry. We understand this perfectly and that is why we cooperate with the management and owners as much as possible to achieve success.

    compliance audits in the context of MDR/IVD and the Medical Devices Act
    support in conducting clinical trials and action studies
    creating and reviewing contracts for medical devices and comprehensive corporate documentation
    introduction of medical devices to the market, support in the import and export of medical devices
    legal support in the field of software used in medicine

    Medical devices - legal services

    a multidisciplinary team providing legal services to the medical devices and medicinal products industry

    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.

    support in advertising medical devices and medicinal products
    representation before regulatory authorities, including the Minister of Health, the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products and the Chief Pharmaceutical Inspector
    patents, trademarks, utility models and industrial models of medical devices and medicinal products
    assistance and advice in the field of product liability and counteracting image crises
    advice in public procurement procedures