E-ssentials Medical Devices, Edition 1, January 2015
International regulatory requirements are still very heterogeneous and dynamically changing. Because of this we have to constantly reinvent ourselves as players in the Medical Device industry. This applies equally to manufacturers and to us as Notified Body. Seen against this background, I have to admit feeling some pride that TÜV SÜD Product Service is celebrating its 25th anniversary as one of the world′s most sought-after inspection organizations.
Our commitment and our participation in clear, safe and applicable requirements for the registration of Medical Devices have gained us sustainable recognition among Medical Device manufacturers, expert committees and regulators. I would like to take our 25th anniversary as an opportunity to thank you for the confidence you have placed in us!
Look back on a quarter century characterized by major changes and constantly new challenges in the interview with my colleague Dr Susanna Kerschl. And to ensure you not only reflect on the past, but also keep pace with the future, our experts inform you in seven updates on the latest developments in the certification of your devices.
I hope you find our newsletter an enjoyable read
Dr Peter Havel
Senior Vice President, Medical & Health Services Global
25 years TÜV SÜD Product Service
TÜV SÜD Product Service was celebrating its 25th anniversary 2014. Dr Susanna Kerschl has been among them right from the very start. From the company′s development from a German test laboratory to its status as one of the world′s leading Notified Bodies – she′s seen it all. To the interview
Following the recommendation by the European Commission (2013/473/EU), Notified Bodies, including TÜV SÜD Product Service GmbH, started this year to conduct unannounced audits (UAA) at Medical Device manufacturers that hold EC certificates. A first summary
Recertification of drug-device combination products
To avoid unnecessary delays in recertification, it is urgently recommended that you check the classification of your drug-device combination product before you submit additional documents. Read more
Beware of confusion!
The understanding and use of the terms “intended purpose” and “indication” differ among Medical Device manufacturers. To the definition
QM standards ISO 13485 and ISO 9001
During the voting period on the ISO/DIS 13485:2014 closed in July 2014, the ISO/TC 210 Technical Committee had received around 800 comments. Due to the large number, the work performed in the working groups is expected to result in a new Draft International Standard ISO/DIS 13485:2015. Read more
When to change to the new edition? A new Med-Info published by TÜV SÜD now supplies manufacturers with key information on the transition. It provides an overview of the situations in the individual countries. Read the Med-Info
Expedited 510(k) Third-Party-Review
If fast market access is of paramount importance, manufacturers opting for TÜV SÜD can significantly reduce the clearance period of their 510(k) submissions. Read more
ANZTPA project stopped
The ministers of health from Australia and New Zealand have announced their governments’ agreement to cease efforts to establish a joint therapeutic products regulator, the Australia New Zealand Therapeutic Products Agency (ANZTPA). Read the statement of ministers