Medical and Healthcare Services’ response to the outbreak
The COVID-19 pandemic is evolving daily, 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. Through our contingency plans, TÜV SÜD is committed to minimizing the impact to all clients while considering the relevant local situation and public health safety guidelines. Where possible, we seek your collaboration in keeping to your scheduled project dates to avoid any impact to your certification status or existing project timelines.
To support the fight against the coronavirus, TÜV SÜD is prioritizing all medical device and in-vitro diagnostic device projects that are related to the treatment, testing, and monitoring of the coronavirus outbreak.
Please review the sections below for more details regarding the contingency plans for our different services.
As a Notified and Certification Body, TÜV SÜD is in communication with our authorising/designating authorities to share our contingency plans in dealing with this extraordinary circumstance. Our plans include combinations of remote and follow-up on-site audits to minimise the risk to all personnel (TÜV SÜD and manufacturer’s).
We appreciate your cooperation in keeping to your scheduled assessment dates to avoid any negative impact on your certification status. 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.
Assessment of technical documentation
Technical documentation assessment continues as usual. For any outstanding issues or other questions, online meetings are also available.
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 process for handling 2020 audits during this extraordinary situation will include the split of the regular on-site audit into two distinct parts: a remote portion of the audit completed off-site within the required timelines of the certification cycle (Part A), and a subsequent on-site portion of the audit scheduled as soon as possible once Part A is completed and within the defined deferral period (Part B). The regular audit cycle will continue without modification, following the completion of both parts. By conducting the audit in two parts the deadline for conducting the on-site audit will be satisfied while avoiding the risk associated with remote auditing of activities that require the physical presence of the audit team on-site.
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.
Click here to view an infographic on conducting successful remote audits.
Certificates with electronic signature
For the moment, you will receive your certificates as a PDF file with an electronic signature. The certificate is fully valid and may be verified through our certificate database. All necessary certification processes are complied with in the issuance of your certificate.
Our test laboratories are open and available:
If you have any questions, please reach out to your client manager or project handler. Our experts remain available via telephone, email or other online tools like Skype or Microsoft Teams.
Get concise information on the latest regulations and standards on medical supplies and devices that is related to COVID-19
Protective equipment regulatory compliance
How to protect yourself against the spread of coronavirus: COVID-19
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