Factsheets for manufacturers are available on the Commission website under the title “Information for manufacturers”:
https://ec.europa.eu/growth/sectors/medical-devices/regulatory-framework_en md_mfr_factsheet
https://ec.europa.eu/growth/sectors/medical-devices/regulatory-framework_en md_mfr_factsheet
Team-NB-Press-Release-Applications-Survey-20180720
Team-NB is now an active member of the EMA database and will be contacted regarding EMA activities.
The Joint Action on Market Surveillance of Medical Devices (JAMS) releases four new downloadable leaflets to help explain the purpose and expected impact of the joint action for: • Healthcare professionals • Manufacturers of medical devices • Notified bodies • Patients and consumers of medical devices. https://www.camd-europe.eu/joint-action-projects/market-surveillance-of-medical-devices-jams/
This document is proposing template on added clauses for agreement between Manufacturers and Notified Bodies regarding the transition period. TEAM-NB-Bullet-Points
EU Regulatory Reads, April 2018: Specific MDR Aspects Start to Come Under Fire
Please click here to download it