Please note: this post was completed on February 6, 2023
Within Europe, agreements have been made to reduce an imminent shortage of medical devices. This shortage is likely to be caused by the introduction of the MDR, the new regulation on medical devices. The European Commission is preparing a proposal for an amendment to the MDR and has also made agreements with the EU member states on the temporary use of a market surveillance measure for medical devices.
The Health and Youth Care Inspectorate (IGJ) is currently working out these agreements in more concrete terms. The IGJ is currently receiving questions from medical device manufacturers on how to make use of this temporary measure. Manufacturers and authorised representatives will receive more information via the IGJ website in the short term and can then contact the IGJ.
The Health and Youth Care Inspectorate (IGJ) is the competent authority in the Netherlands to apply Article 97 MDR. You can submit your application by email to the BRIC: CIBGartikel97@minvws.nl. The BRIC will then provide you with information about the procedure and a form to submit your application. Given the draft of the 'implementing act on the transitional provisions for certain medical devices and in vitro diagnostic medical devices' on the extension of the transition periods, the inspectorate assesses the applications in order of the expiry dates of the CE certificates.
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