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MDR

The European Medical Device Regulation (MDR) and the EU regulation on in vitro diagnostic medical devices IVDR replace the existing medical device regulations.

Based on a high health protection level for patients and users, the regulation ensures a seamlessly functioning internal market for medical devices while taking into account the small and medium-sized companies that operate in this sector. The regulations concerning the further provision on the market of medical devices that have already been put into operation, such as in connection with the sale of used devices, will also be harmonized.

The EU regulations, the MDR and IVDR, have been valid since May 25, 2017.
Glossary Technical terms at a glance

M

Malfunction analysis MDD-Directive MDR Measurement System Analysis Mechatronic FMEA Mechatronics Medical device Medical Devices Act Medical Device Regulation

O

One Piece Flow Operating period Operating state

P

PDCA PDCA cycle Poka-yoke Population PPAP Product development process Production control plan Property

Q

QFD QMS Quality Quality management Quality management standard