Denmark: Life Sciences, Biotechnology & Nanotechnology

Polycystic Ovary Syndrome has been officially renamed Polyendocrine Metabolic Ovarian Syndrome following a 14-year global medical consensus. The new terminology better reflects the condition's complex hormonal, metabolic and reproductive nature, moving beyond the misleading reference to ovarian cysts. What does this fundamental shift in medical understanding mean for patent applications and intellectual property strategy in women's health innovation?

The EU adopts rules restricting the access of economic operators and the use of medical devices originating in the People's Republic of China to the EU public procurement market.

The Medical Device Coordination Group ("MDCG") has recently published guidance on the interplay between the AI Act and the MDR/IVDR.

Recruiting participants is a cornerstone for the success of clinical trials. This newly released guide offers practical tools to identify and engage eligible participants as well as in-depth insights into a variety of recruitment methods...

The Danish Ethical Committee for the Pharmaceutical Industry (ENLI) has announced (i) increased fees for notifications and pre-approvals, along with higher fines for code violations, and (ii) the launch of the new notification system "ENLIsag".

The European Medicines Agency (EMA) has launched a pilot programme that aims to support the development and evaluation of orphan medical devices.

With the new pharmaceutical legislative package, the EU Commission is proposing a new classification mechanism for borderline products.

In June, the European Medicines Agency's Emergency Task Force (ETF) and the European Commission held a workshop on clinical trials in light of the experiences...

MedTech Europe has prepared a form (Manufacturer's Declaration") that manufacturers can use in order to comply with the transitional provisions in the MD and IVD Regulations...