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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.

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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.

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.   

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.

With a little more than a month to go till the date of application of the MDR, the industry is understandably concerned about the readiness of the system. However, another deadline is looming, as the five-year transition period of the IVDR is almost over, with the date of application of the IVDR only one year away. The IVDR introduces the requirement for all products falling into a higher risk class than A to be certified by a notified body. This applies particularly to a large number of products that manufacturers have been able to place on the market without the involvement of a notified body. Only a small portion of IVDs will benefit from the grace period the IVDR grants viz. the few that were already required to be certified by a notified body under the Directive.

The MDCG has only published two documents on the IVDR implementation so far, the latest discussing the transitional provisions for certification of class D in vitro diagnostic medical devices.

In addition to applying to a notified body, some class D applications must be reviewed by an expert panel and/or tested by an EU reference laboratory (EURL). The latest MDCG document outlines how the provisions of the IVDR can be applied during the transition period, which means before the date of application on 26 May 2022. It states that in the absence of the required expert panel and/or EURL:

  • notified bodies may not issue a certificate before the expert panel is operational and, for the devices that require consultation of the panel, before the panel has provided its views;
  • if no EU reference laboratory (EURL) is designated for the device in question, the expert panel should provide its views within 60 days;
  • the notified body and manufacturer should follow the EURL-related provisions on sample or batch testing from the time that the EURL becomes operational;
  • the notified body should follow the EURL-related provisions for performance verification at the time of the re-certification.