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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.   

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.

The latest announcement of the European Commission aims to alleviate some of the legal uncertainty surrounding EU market access of Swiss medical devices after the date of application of the MDR in May 2021. To mitigate supply disruptions on the EU market, the EU proposes a limited modification to the current Mutual Recognition Agreement, which would grant certificates issued by a Swiss NB the same grace period the MDR grants to certificates issued in the EU.

Once accepted by both parties, this amendment could enter into force on 26 May 2021. The detailed wording of the amendment is not known yet, and the impact has to be analysed once the amendment is available. But the EU Commission emphasizes that this amendment does not include new certificates issued under the MDR. The MRA will only be updated to include the MDR once substantial progress is made on the Swiss side towards signing the Institutional Framework Agreement.

This proposed amendment to the MRA does not change the condition that third country requirements will apply as of 26 May 2021. Swiss manufacturers should continue their preparation to comply with third country requirements for products to be placed on the EU market, namely appoint an authorized representative in the EU or EEA and accordingly adapt the labelling of the products.

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.

Die Schweiz sagt Ja zum Freihandelsabkommen mit Indonesien. Nach der Ratifizierung des Abkommens werden viele Produkte von tieferen Handelsbarrieren und Zöllen profitieren. Planen sie als Hersteller diese Erleichterungen zu nutzen und ihre Medizinprodukte auf dem indonesischen Markt in Verkehr zu bringen? Oder möchten sie ihre bestehende Produktpalette auf dem indonesischen Markt erweitern und benötigen Unterstützung? Wir beraten und unterstützen sie gerne mit unserem umfassenden Regulierungs- und Zulassungs-Know-How.

Wie weltweit üblich, gelten auch in Indonesien für medizinisch-diagnostische Geräte spezifische Pflichten gegenüber den Gesundheitsbehörden um eine gute und medizinische Versorgung der indonesischen Bevölkerung sicherzustellen. Für konkrete Anfragen wenden Sie sich an: Diese E-Mail-Adresse ist vor Spambots geschützt! Zur Anzeige muss JavaScript eingeschaltet sein!