Glossary

Manufacturer [MDR/IVDR]

MDR IVDR

‘Manufacturer’ means a natural or legal person who manufactures or fully refurbishes a device or has a device designed, manufactured or fully refurbished, and markets that device under its name or trademark.

 

[Definition under (EU) 2017/745 Article 2 No. 30 also corresponds to definition under (EU) 2017/746 Article 2 No. 23]