COVID-19

18 March 2020

The situation with regards to the COVID-19 pandemic is evolving on a daily basis, with effects going far beyond the directly affected areas with outbreaks. During this time, the safety and well-being of our colleagues and clients is our highest priority.

Notified Bodies are in communication with their designating authorities to share contingency plans to deal with this extraordinary circumstance.

Please know that TÜV SÜD’s plans include combinations of remote and deferred audits, while minimizing the risk to all Notified Body and manufacturer’s personnel and maintaining designation and accreditation requirements. Even though quarantine restrictions might make it impossible to perform physical audits, we are putting all our efforts to complete the remaining MDD projects as well as to support the full implementation of the MDR. To that extent, we ask for your collaboration and flexibility.

Please remain in close contact with us and inform your client manager immediately of any potential issues, such as temporary closure of sites or delays in planned submission of documents, which may prevent delivery of a scheduled assessment.

We would like to inform you that TÜV SÜD is prioritising all medical device and in-vitro diagnostic device projects that are related to the treatment, testing, and monitoring of the coronavirus outbreak.