Medical devices may only be placed on the Union market if the requirements of the respective European regulation (MDR, IVDR) are met. These include, among other things, compliance with the general safety and performance requirements, the selection and implementation of an appropriate conformity assessment procedure, and the issuance of a corresponding declaration of conformity. By affixing the CE marking, the manufacturer declares that the respective medical device meets all applicable requirements.

The manufacturer is solely responsible for the medical device and its design and properties. He defines the medical intended purpose, in particular the type and manner of the principal effect and application of the medical device, and classifies it in the respective medical device class. For medical devices of higher risk classes, a notified body must be involved.

In vitro diagnostics (IVDs): These tests are performed on biological samples to determine a person's state of health.

Transition periods: Extended transition periods apply to devices that require a notification body for conformity assessment in accordance with Regulation (EU) 2017/746.

Common specifications: Detailed practical rules specifying how certain types of devices should comply with the requirements of Regulation (EU) 2017/746.

Expert Panel: An independent scientific panel established by the Medical Devices Regulations and Commission Implementing Decision 2019/1396. 

The latest updates and highlights on these topics can be found at the following link: Medical Devices - In Vitro Diagnostics - European Commission (europa.eu)