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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..  

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.

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.   

An amendment to the Medical Devices Ordinance (MedDO) has been prepared, which will come into force on 26 May 2021 if the Mutual Recognition Agreement (MRA) between Switzerland and the European Union (EU) has not been updated by that date. This amendment is referred to as the Eventual-MepV (Contingency MedDo), but the explicit content is not publicly available yet. As the clock is relentlessly ticking towards 26 May 2021, Swiss Medtech has been able to share some relevant information for the industry to prepare for the regulatory requirements the amendment introduces:

Swiss Authorised Representative: The Eventual-MepV provides for transitional periods for the appointment of a Swiss authorized representative, including corresponding labelling:

  • Until 31 December 2021 for Class III devices, Class IIb implantable devices, and all active implantable devices.
  • Until 31 March 2022 for non-implantable Class IIb devices and Class IIa devices.
  • Until 31 July 2022 for Class I devices, systems, and procedure packs.

Access to the technical documentation: Access to the technical documentation may be provided by keeping a copy available on the authorized representative’s premises or by a contractually guaranteed assurance that delivery will occur within seven days at Swissmedic’s request.

Registration obligations: In the absence of Eudamed, registration obligations will be fulfilled by submitting information to Swissmedic. Economic operators who have already placed devices on the market before 26 May 2021 following the MDR and IVDR must complete the registrations by 26 November 2021.

Summary of Safety and Clinical Performance (SSCP): The validated SSCP is not uploaded by the Notified Body in Eudamed but has to be made publicly available by the manufacturer - for example, on its website.