Medical and Healthcare Services’ response to the outbreak
Updated on 6 April 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 and Certification Bodies are in communication with their authorising or designating authorities to share contingency plans to deal with this extraordinary circumstance.
Please know that TÜV SÜD’s plans include combinations of remote and follow-up on-site audits, while minimising the risk to all Notified and Certification Bodies 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. At the same time at our Certification Bodies, we continue to serve clients that require certification under schemes like MDSAP or SCC. 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.
Below are some important information regarding our test laboratories:
Assessment of technical documentation
Technical documentation assessment continues as usual. For any outstanding issues or other questions, online meetings are also available. Please contact your project handler for more information.
If COVID-19 has resulted in the prohibition of on-site assessments in your country, most accreditation bodies now allow remote audits either in combination with follow-up on-site audits or stand-alone. The applicable audit approach will be scheme specific and can be discussed in further detail with your project handler during the audit planning process. Our first experiences have shown that those remote audits are well accepted by our clients, and have similar effectiveness as normal on-site audits. Please avoid postponing your regular audits and leverage remote audits to maintain your certification status.
Below are some basics for conducting successful remote audits:
If you have any questions on any other topics, our experts are available via telephone, email or online tools like Skype or Microsoft Teams.
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