We Provide Medical Devices

Medical Devices Ordinance

We are your competent point of contact for all regulatory and market related questions. Lema Project Management LLC supports and facilitates the work of manufacturers of medical devices, combination products, and in-vitro diagnostic (IVD) medical devices.

We are ready to answer all your questions regarding market requirements, the Medical Device Directive and especially the new EU regulations on medical devices.

The Medical Devices Regulation (EU) 2017/745 and the In Vitro Diagnostics (IVD) Regulation (EU) 2017/746 pose challenges for manufacturers of medical devices and IVDs.

Substance-based medical devices with physical effects, such as lozenges, dermatological products and nasal sprays, are assigned to a higher risk class according to the Medical Devices Ordinance.