Your responses to our newsletter show that there is still very much interested in the topic of unannounced audits. Having conducted numerous unannounced audits on site, our auditor, Jürgen Kunte, knows which questions arise again and again. In this issue of our Newsletter, he addresses the testing of product samples and explains what you can do to ensure these tests run smoothly.
Contributions by other authors also address aspects that seem to be mere details – but may
still decide on the success or failure of a product test. To ensure you know what is important.
We hope you find our newsletter interesting!
MHS Services Manager
TÜV SÜD Product Service, UK
Recommendation 2013/473/EU of the European Commission requires the performance of sample testing in the course of unannounced audits for high risk medical devices.
Read here what to expect from product testing of high risk devices.
With effect from the third quarter of 2015, DuPont™ will transition the manufacturing of Tyvek® to a new process. Medical device manufacturers, that use the 1059B and 1073B Tyvek® grades in their products, must submit significant change notifications. TÜV SÜD Product Service has developed a questionnaire to assist with submission. Read more
If a wearable has a diagnostic or therapeutic purpose it requires approval for its target markets just like any other medical device. Read here,what manufacturers should know.
According to European Directive 93/42/EEC, instructions for use must include information about performances and any undesirable side effects and also, where appropriate, specific and useful information to avoid special risks. Read here how to address risks in instructions for use.
Proactive update of Clinical Evaluation Reports (CERs)
According to the European Directive 93/42/EEC it is required to actively update the CER with data obtained from the post-market surveillance. However neither the Directive nor the MEDDEV guidance document 2.7.1 provide information on a specific requirement regarding the period for updating. Read more.
The 3rd edition of the IEC 60601-1 standard includes a host of new requirements. Even though the publication of this standard dates back more than nine years, medical device
manufacturers are still providing incomplete or unclear documentation of some
of its aspects. Read more