A waiver of clinical data under MDR Article 61(10) is possible if the product’s nature, sufficient non-clinical evidence, and risk management justify it. Instead of clinical investigations, manufacturers may rely on technical testing, pre-clinical evaluation, and performance data to demonstrate safety and compliance.

The World Health Organization (WHO) is a specialized agency of the United Nations for public health, based in Geneva. It was founded on 7 April 1948 and has 194 member states. According to the WHO constitution, its goal is to achieve the best possible level of health for all people. The focus is primarily on combating infectious diseases.

Japan is the second largest market for medical devices in the world and offers manufacturers a lot of potential. However, product approval there is a particular challenge.

In recent years, South Korea has increasingly become an important market for medical devices. The requirements vary in this regard.

We are celebrating our anniversary. We have been a partner to the healthcare industry for 20 years and support companies with the approval of medical products