Informative presentation on regulations affecting certification of medical devices
SGS Hungária Ltd. in cooperation with Device Testing and Clinical Engineering (directorate of National Institute for Quality- and Organizational Development in Healthcare and Medicines) and Office of Health Authorisation and Administrative Procedures Department for Medical Devices held presentations about the 2013/473/EU Recommendation as well as the Commission Implementing Regulation (EU) No. 920/2013 on 10th November, 2014.
The Commission Recommendation 2013/473/EU contains among others audits and reviews in the field of medical devices, while the Implementing Regulation (EU) No. 920/2013 includes obligations to manufacturers and certification bodies.
The new rules are especially important because they apply to all certification bodies and medical device manufecturers.