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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.

ISS talk RentréeduDM

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: Diese E-Mail-Adresse ist vor Spambots geschützt! Zur Anzeige muss JavaScript eingeschaltet sein!.  

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 Diese E-Mail-Adresse ist vor Spambots geschützt! Zur Anzeige muss JavaScript eingeschaltet sein!.  

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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.

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Klicken Sie auf den Anmeldebutton des Flyers oder hier, um am Mittwoch, 30. Juni 2021 an diesem kostenlosen, interaktiven Webinar teilzunehmen.

Nach einem ersten erfolgreichen Webinar zu den regulatorischen Anforderungen in Europa haben sich die ISS AG und ihr asiatischer Partner, die Qualtech Consulting Corp., erneut zusammengeschlossen, um Ihnen einen Einblick in die Neuerungen des Medizinprodukte-Registrierungsprozesses in China zu geben. Wir haben ein kompaktes Webinar konzipiert, das sich mit der New Regulation for Supervision & Administration of Medical Devices (RSAMD) befasst und die folgenden Themen behandelt:

  • Innovationsfördernde Massnahmen der NMPA, u.a. durch vereinfachte und vorrangige Dossierprüfung und Zulassungsverfahren, Pfade für bedingte Zulassungen sowie Massnahmen zur Förderung der Durchführung klinischer Studien für innovative Medizinprodukte.
  • Neue Verpflichtungen für Registrierende durch ein neues, landesweit eingeführtes System für Zulassungsinhaber ("MAH").
  • Risiko- und Qualitätsmanagement: Verantwortung des MAH für die Sicherheit, Qualität und Wirksamkeit des Medizinprodukts während seines gesamten Lebenszyklus.
  • Überarbeitung der Anforderungen an klinische Bewertungen und Ausweitung der Ausnahmen von klinischen Studien.
  • Verbesserung des Überwachungssystems und höhere Strafen für begangene Verstösse.

Fragen können Sie uns gerne vorab über das Anmeldeformular oder über Diese E-Mail-Adresse ist vor Spambots geschützt! Zur Anzeige muss JavaScript eingeschaltet sein! zukommen lassen.

Due to the new EU Medical Device Regulation, manufacturers face increasing requirements regarding Post-Market-Surveillance (PMS). To support you with your PMS needs we have put together a package of services. With our different PMS packages we support you in bringing your PMS System up to date. If you do not want to bother with PMS, we even offer an outsourcing solution with full PMS & PMCF MDR compliance warranty. Contact us now to find out which of our PMS Packages is best for you.

PMS & PMCF with MDR Compliance Warranty

Are you suffering from an increasing number of post-market requirements in the European market? You don’t know how to handle all of this in the future? We have a solution for you. Our experience shows that PMS & PMCF activities can be analysed, remediated or even outsourced in an easy and effective way.

That is why we developed multiple solutions with a focus on class I up to class IIb devices. All are tailored to your needs, giving you the most value out of your post market data.