New regulatory requirements for Medical Devices

On 5 April the Council of the European Union adopted the new Medical Devices Regulation (MDR) that will update the regulatory framework for the approval and marketing of medical devices and in vitro diagnostics in Europe.

The MDR will introduce more stringent procedures for conformity assessments, tighten regulation by national authorities of notified bodies, call for the incorporation of unique device identifiers on all medical device labels, increase patient protection during clinical trials, and add data requirements for study sponsors.

Hear more about these changes and new features in our Workshop: Regulatory requirements for Medical Devices – Influence of the new Medical Devices Regulation presented by Dr Bassil Akra the vice president of the global focus teams (Cardiovascular, Orthopedic and Clinical) at TÜV SÜD Product Service.

Target audience

This workshop is aimed at everyone working in the field of medical devices medical writing and all persons involved in clinical research.

The language of the workshop is German.


16.05.2017, Berlin

We look forward to your call or your message.

Click here for more information Regulatory requirements for Medical Devices – Influence of the new Medical Device Regulation