Product Testing and Certification

Medical device auditor training 2023

12. May 2023

A two-day medical device auditor training is being held at SIQ Ljubljana. It is dedicated to the topics covered by Regulation (EU) 2017/745. The event is attended by more than 40 auditors from Slovenia, Croatia, Serbia, Austria, Germany, and the UK.

On the first day of training, we addressed the transitional provisions of Regulation (EU) 2023/607, the extension of the validity of certificates, and the MDCG guidance documents. Today, we are continuing with other topics, such as the UDI-DI system, authorized representatives, labeling, and with the exchange of valuable experiences from the first MDR audits.

We would like to thank everyone for their participation, professional debate, and exchange of good practice!

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