We Attended the International Conference in Russia

SIQ Ljubljana representatives introduced the general requirements of the medical directive.

On July 18 and 19 2018, an international conference about the EU medical directive for medical devices manufacturers took place in Moscow. The conference was organized by our Russian partner, Haensch развитие качества.

The purpose of the conference was to familiarize the participants with the requirements of the EU Medical Devices Directive 93/42/EGS and the transition to the new regulation MDR (EU 2017/745), while also introducing the requirements for importing medical devices to EU member states.

In recent years, Russia's government has been very supportive of the import of medical devices to the EU market. The government covers 50- to 100-percent of the cost of certification and counselling to organizations that wish to import their products to the European market. The demand for the certification is rising.

The conference was mostly attended by representatives of quality managers and

company CEOs. SIQ Ljubljana representatives have introduced the general requirements of the current medical directive, the change and transition to the new MDR regulation, the required documentation, quality management system in accordance with ISO 13485, and the entire certification procedure.

SIQ Ljubljana representatives, Vesna Rems Odar in Alenka Toplak, with representatives from “Hensh Razvitie Kachestva”, the Moscow conference organizers.