Notified Bodies are organizations designated and notified by EU Member States to assess the conformity of certain products before they are placed on the EU market.

MDR 2017/745 Annex II medical device technical documentation is a clear, well-organized and readily searchable set of documentation prepared by the manufacturer to demonstrate the safety and performance of the device.

Determining the medical device classification and the applicable classification rule is the first step in the EU CE marking process. Depending on the device class and rule, technical documentation and a Notified Body application may be required.

The IVDR Regulation sets out new EU requirements for placing in vitro diagnostic medical devices on the European market.

IVDR

Ecological agriculture is a controlled and certified form of agricultural production in which chemical inputs are avoided and products are managed from production through consumption to minimize chemical residues.

FDA stands for the U.S. Food and Drug Administration. It is responsible for areas including dietary supplements, food, medicines, blood products, biological medical products, radiation-emitting devices, cosmetics and veterinary products.

Masks bearing the CE marking are referred to as CE-marked masks. The CE marking indicates that the mask may be circulated and sold within the European Economic Area (EEA).