Events examine EU regulations and directives

European events cover regulatory affairs in the medical device sector

RAPS Roadshow: Examining the new European medical device regulations

4 May 2017 17:00–20:00, Munich, Germany

Join regulatory professionals in your region for the first Regulatory Affairs Professionals Society (RAPS) Roadshow in Europe. This half-day event will feature RAPS’ executive director Paul Brooks, an expert on medical device regulation. His presentation will address the key changes introduced by the new European Medical Device Regulation (MDR) including the expanded scope of the regulation, and changes in classification and conformity assessment.

EU regulatory essentials, medical device and in vitro diagnostics: Transitioning from current directives to new regulations

4 July 2017 10:00–17:30

5 July 2017 09:00–12:30

Brussels, Belgium

Offered for the first time in Europe, this one-and-a-half day workshop will examine the current directives, and focus on the new EU regulatory expectations for medical devices and IVDs as introduced by the new Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR).

The workshop is an opportunity to learn from experienced regulatory affairs professionals who are closely engaged with the new emerging EU regulatory requirements. They will share important insights, unique perspectives and address the challenges of the new regulations. There will be two general sessions relevant to all device/IVD manufacturers supplemented with two comprehensive tracks that delve deeper into the specifics of the new MDR and IVDR. The tracks will dig into new classification, conformity assessment, safety and performance, clinical/performance evaluation, technical documentation and postmarket requirements.

By the end of the workshop, you will be aware of the key changes introduced by the new regulations. You also will receive expert interpretation of new expectations and be prepared to develop transition plans to navigate market access (CE Marking) expectations for both new and legacy devices being placed in Europe. If you are working in medical device/IVD regulatory affairs and quality assurance, this workshop will be invaluable.

For more information and to register: http://www.raps.org/mdr-ivdr/#inperson