Regulation

Regulation

Views on the rules and regulations that govern MedTech.

New Medical Device Regulation – an obstacle to progress
Member of the Management Board, B. Braun Melsungen AG
On May 25 th , 2017, a new era began. The date marks the beginning of the Medical Device Regulation, the MDR in short. It provides a new framework for the...
Director Regulations & Industrial Policy - MedTech Europe
One year has now passed since the ‘new’ EU IVD and medical devices regulations entered into force. Since Day 1, the medical technology industry has been...
Director Regulations & Industrial Policy - MedTech Europe
We are now over 15% of the transition period of the new European IVD Regulation (IVDR) and over 25% of the Medical Devices Regulation (MDR) transition. That...
Director Regulations & Industrial Policy - MedTech Europe
At long last, the date has arrived. Organisations who aspire to be Notified Bodies under the European IVD and medical devices regulations can submit their...
Journalist, editor, author
As Germany goes to the polls, the VDGH, which represents in vitro diagnostics companies in Germany, has published a new policy paper on the future of...