Medical Devices

The manufacturing and distribution of medical devices is one of the fastest-growing segments of the industry. Simpler administrative procedures and lower market entry barriers compared to medicinal products make medical devices an attractive option. However, legal uncertainty often arises with "borderline" products that could potentially be classified as medicinal products. This requires not only scientific or technological assessments, but also legal risk evaluation.

These issues are increasingly important due to the application of EU regulations: Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic devices, which took effect in May 2020. These new EU-wide regulations replaced previous national laws and require businesses to take compliance steps. Our cooperating legal experts will guide you through this transition and help align your operations with the new legal framework.

Licensing Agreements

Bringing an innovative medicinal product to market takes many years and can cost hundreds of millions of dollars—with no guarantee of return on investment. Few pharmaceutical companies can afford to take such risks. So where do new drugs come from? Mostly from generic products—equivalents of already registered and proven medications. Offering the same therapeutic effects, generics involve significantly lower costs for both producers and patients.

They are typically introduced to local markets based on a license agreement, making it a crucial document for the legal use of the product. Our legal team has taken part in numerous license agreement negotiations covering medicinal products, medical devices, and dietary supplements. We’ve negotiated with licensors from the UK, Germany, Greece, Portugal, Spain, Cyprus, and Italy.

Market Authorization

The distribution of medicinal products is one of the most highly regulated and harmonized areas within the EU. Practically every step in the product lifecycle requires proper authorizations, permits, or administrative approvals. While related products—like medical devices, cosmetics, or dietary supplements—are not regulated as strictly, they also follow specific legal frameworks. Reimbursement is another legally complex and critically important aspect of market operations.

Thanks to our in-depth understanding and years of experience, we support clients with:

• obtaining or modifying marketing authorizations,

• changing the marketing authorization holder,

• obtaining or modifying manufacturing/import permits,

• obtaining permits for wholesale distribution or parallel import,

• drafting and negotiating distribution agreements,

• regulatory compliance in advertising and promotion,

• reimbursement of medicinal products, medical devices, and dietary foods.

M&A Transactions

The life sciences market (broadly covering medicinal products, medical devices, dietary supplements, cosmetics, and functional foods) has long led in the number of mergers and acquisitions. This includes share and equity transactions, as well as the sale of product portfolios.

M&A deals in this sector require specialized knowledge and must take into account a number of administrative regulations—not all solutions applicable in other sectors can be used for pharmaceuticals or medical devices. Businesses operating in or entering the life sciences market are stepping into a sea of opportunities.

In handling M&A transactions, we provide support in:

• pre-transaction advisory (due diligence analysis),

• transaction execution (drafting and negotiating transaction documents, including protective instruments),

• post-transaction assistance (as the purchase of rights or shares usually begins a new phase involving reporting to URPL, UPRP, GIF, KSIOK, and KRS).