Sandra Item and Bernhard Bichsel take over the management of ISS AG as co-CEOs and become owners of the company at the same time.
Hansjörg Riedwyl will continue to work for the company.
The communication for our customers and partners can be found here.
Communication en français ici.
Bernhard Bichsel is co-author of the article (German) published in the journal "Life Science Recht" on the causes of possible supply deficits for medical devices in Switzerland and outlines possible solutions to prevent a supply crisis.
ISS AG invited to the EPHJ, the largest international trade show dedicated to high precision, in order to share experience on the development of medical devices at the MedTech roundtable. Contact us as well for strategic or operational support in Compliance, Clinical or Digital MedTech at This email address is being protected from spambots. You need JavaScript enabled to view it..
Read more here
On October 7th, Annika Lörtscher, our Senior Regulatory Affairs Manager and Teamleader International Market Access, gave an overview on the latest regulatory requirements in Russia, China and Brazil.
The conferences of La Rentrée du DM deal with the concrete concerns of medical device manufacturers in the daily exercise of their activity. This event is intended for all those who wish to master the regulatory and clinical aspects in the development of medical devices.
Feel free to contact us for any strategic or operational support regarding the registration and market maintenance of medical devices in these countries, as well as in any other market of your interest: This email address is being protected from spambots. You need JavaScript enabled to view it..
At the beginning of May 2021, the first version of the European Medical Device Nomenclature (EMDN) was released. The EMDN plays a vital role in the functioning of the European database on medical devices (EUDAMED) and fulfils the requirement in Article 26 of the MDR.
The EMDN is based on the Classificazione Nazionale Dispositivi medici (CND), the Italian nomenclature that was also implemented in Greece and Portugal. In the European nomenclature, medical devices are divided into categories, groups, and types, with each level being assigned its own alphanumeric code. If a code has not yet been created for a medical device, a new one must be applied for.
While the Italian version of the nomenclature is considered final and official, the English Version underwent an additional validation step in the form of a one-month online linguistic consultation. Until 4 June 2021, users and the wider healthcare community were invited to provide feedback on translation errors or syntax suggestions.
According to the requirements in the MDR, the EDMN is publicly accessible and can be downloaded on the webpage of the European Commission. Where possible, the EMDN will also be mapped to the GMDN. A sub-group of the MDCG on nomenclature has been established to oversee regulatory activities in this area; the group defines the rules and processes related to the creation, update, maintenance and use of the EMDN. For more information, the European Commission recently published a Q&A sheet with further information on the European Medical Device Nomenclature.
The EMDN code in EUDAMED will be associated to each UDI-DI and plays an important role in the registration of medical devices. It will be an integral part of the device documentation and the technical documentation, sampling of technical documentation conducted by notified bodies, the post-market surveillance, vigilance, and post-market data analysis. We recommend that you familiarise yourself with the EMDN, even if the final version has not yet been published.
