The guidance document "MEDDEV 2.12-1 rev 8" offers a comprehensive guidance on best practice for medical device post-market surveillance (materiovigilance). A manufacturer of medical devices is required to report incidents (serious adverse events) to the national competent authority of the member state the company resides in. The Medical Device Regulation (EU) 2017/745 (MDR) provides in §2 the following definition of post-market surveillance: