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.

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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.

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.

In January 2021, ISO 10993-23:2021 Biological evaluation of medical devices – Tests for irritation was published. The new standard specifies the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce skin irritation and includes an important test model with regard to animal welfare.

Until this new standard was published, ISO 10993-10 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization was applied to assess skin irritation for medical devices, in vivo. ISO 10993-23:2021 technically replaces the skin irritation test from Part 10, by outlining both the well-established animal irritation test model, along with a laboratory grown human skin model as a validated alternative to predict and classify the irritation potential of medical devices, materials or their extracts according to ISO 10993-1 and ISO 10993-2.

The remarkable part here is the recognition of an in vitro irritation model. This test system uses a reconstructed human epidermis model (RhE) and provides a recognized alternative to in vivo irritation testing. Even though this is not a new procedure, the incorporation into an international standard is an important step in reducing animal testing in the development and clinical evaluation of medical devices. New methods in general have a hard time being accepted for regulatory use before inclusion into ISO 10993, so the recognition of ISO 10993-23:2021 as an important step to get away from animal testing is eagerly awaited.