Since the start of this year, Notified Bodies have been implementing the new requirements of the European legislation for Medical Devices and conducted the first unannounced audits. These first experiences show that in practice the issue is not as bad as it looked. Professionally managed companies that prepare well for unannounced audits generally master these audits quickly and without major interruptions.
To help you and your company to draw up an action plan for unannounced audits, we have prepared a brochure with the answers to 54 frequently asked questions. In this newsletter, we have summarized this brochure and other sources of information on unannounced audits.
I hope you find this and all other subjects in our newsletter an interesting and informative read.
Timely registration in the target markets is the critical success factor of every innovation in the medical device industry. Read more
For a short time to market and smooth market access accurate planning and determination of the methods that ensure compliance with the Medical Device Directive (MDD) and other applicable directives are of the essence. Read more
All you need to know about unannounced audits
TÜV SÜD has now published a brochure in which the experts give answers to the 54 most important questions about unannounced audits asked by manufacturers.
New requirements for Notified Bodies
EU Commission implementing Regulation No. 920/2013 establishes a new framework for the designation and supervision of Notified Bodies operating under the EU’s Medical Device Directive and the EU’s Directive for Active Implantable Medical Devices.
Kazakhstan: Faster registration of Medical Devices
TÜV SÜD Product Service and the Kazakhstan Ministry of Health will collaborate in the registration of Medical Devices to shorten the access to state-of-the-art medical technology. Read more