Free basic check ISO 13485: Quality management for medical devices and IVD

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We are now offering all manufacturers of Class I medical devices a free initial consultation on the introduction of a quality management system in accordance with ISO 13485!

In a free 2-hour consultation, our experts will answer your individual questions and show you the best way to meet the legal requirements!

Manufacturers of Class I medical devices or Class A IVDs must implement a quality management system (QMS) in accordance with the MDR/IVDR, in particular Article 10(9).

ISO 13485 is the internationally recognized reference standard for a quality management system in the field of medical devices. Although certification according to ISO 13485 is not required for Class I medical devices, the introduction of a state-of-the-art quality management system is mandatory in order to demonstrably meet the MDR/IVDR requirements.

ISO 13485 certification is therefore the ideal solution for meeting the MDR/IVDR requirements regarding QMS.

Important: According to the Austrian Medical Devices Act (MPG), market surveillance authorities are required to conduct regular inspections of all medical device manufacturers to ensure compliance with MDR/IVDR requirements.

Find out more in good time with our ISO 13485 basic check!

important deadlines

  • There are generally no new transition periods for Class I MDR medical devices, as these products do not require certification by a notified body and must already be fully compliant with the MDR since May 26, 2021.
  • Class I products that are classified higher under the MDR (e.g., Is, Im, Ir) are an exception: For these products, the transition period runs until December 31, 2028, provided that they were previously placed on the market as Class I products under the MDD (Medical Device Directive) and now require a Notified Body.
  • For existing IVD products (legacy devices), there are staggered transition periods depending on the risk class:
    • Class D: The application for conformity assessment must be submitted to a notified body by May 26, 2025, at the latest. The written agreement with the notified body must be concluded by September 26, 2025. The transition period for placing the device on the market then runs until December 31, 2027.
    • Class B and sterile Class A: The application must be submitted by May 26, 2027.

Free basic check ISO 13485

In a joint consultation, we offer you a basic assessment for the introduction of a quality management system in your company. Clarify your individual questions with our experts!

  • 2-hour consultation!
  • Remote with one of our experts!
  • FREE!

Limited places available – register quickly at office@encotec.at !

If you have any questions, we are happy to help: office@encotec.at or +436508863491.