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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..  

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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.

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.

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Click on the flyer registration button or just here for this free interactive webinar on Wednesday, 30 June 2021.  

Following a first successful webinar on the European regulatory requirements, ISS AG and its Asian partner, Qualtech Consulting Corp., joined again their forces to provide you with an insight into the registration of Medical Devices in China. We have designed a compact webinar addressing the New Regulation for Supervision & Administration of Medical Devices (RSAMD) and covering the following topics:

  • NMPA’s measures supporting innovation, incl. simplified and priority review pathways and approval procedures, conditional approval pathway as well as measures encouraging the undertaking of clinical trials of innovative medical devices.
  • New obligations for product registrants under the new nationwide adopted marketing authorization holder (“MAH”) system
  • Risk and quality management: MAH’s responsibilities for the safety, quality, and efficacy of the MD throughout its entire life cycle
  • Reform in clinical evaluation requirements and broader exemption from clinical evaluations
  • Improvement of the supervision system and enhancing enforcement via an increase in penalties for committed violations

Feel free to share in advance any questions you might have on this topic via the registration form, or via This email address is being protected from spambots. You need JavaScript enabled to view it..  

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.