Both prescription and non-prescription eyeglasses are considered medical devices under the regulatory framework of the Regulation (EU) 2017/745.

The field of medical devices is rapidly evolving, and as technological advancements continue, so do the regulatory frameworks governing their approval and marketing.

The time has finally come: almost 1.5 years after the MDR came into force, the MDCG has published the long-awaited guidance document for the preparation of the PSUR.

Many problems lurk when collecting clinical data as part of the PMCF. We help you to create a sensible strategy.

Post-market surveillance for medical devices as an efficient process for practicability and added value.

In China, Post Market Surveillance (PMS) is an important component of the regulation for medical devices, ensuring the safety and effectiveness of these products.

We will show you why a quality assurance agreement is an important and central document of the MDR, and should make sure it is always up to date.