Since the 2017 publication of the medical device regulation (MDR) and the IVD regulation (IVDR), EU regulations for medical devices and IVDs have undergone a profound change. Manufacturers are now ...

To set the context, it is important to consider the underlying EU’s product safety legislation, which consists of three components: General Product Safety Regulation (GPSR) – Regulation (EU) 2023/988 ...

Medical 3D printing, also known as additive manufacturing, is the use of 3D printing technology to create medical devices, implants and prosthetics. Research led by Trinity College has found that a ...

When the EU adopted the AI Act (Regulation (EU) 2024/1689, “AIA”), soon concerns were aired that this would create an additional regulatory burden for AI-based medical devices (“AIMD”). The idea was ...