Articles tagged with: Legacy device

The 5 less obvious aspects, ranked by impact, to manage in order to complete the MDR conformity assessment process.

The recent extension of the MDR has raised several questions. This article provides answers to the most common ones.

The European Commission has accepted the proposed MDR extension. MDD certificates remain valid beyond their expiration date.

The European Commission is voting on a further postponement of MDR applicability to 2027/2028 for medical devices.

Concerns about the disruption in the supply of medical devices are well-founded. The MDR is the cause, and now a solution is being sought.

Regulation 2017/745 (MDR) defines the dates for compliance with the requirements for obtaining and applying the UDI code.

The latest Eudamed update allows for the registration of medical device UDI codes. How to access the registration module.