In Vitro Diagnostics and Medical Devices

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Updated AER codes published by IMDRF!

The International Medical Device Regulators Forum (IMDRF) published an updated version of the Adverse Event Reporting (AER) codes and terms on 2 March 2021. These codes/terms are to be used in the EU Vigilance reporting.

New MDCG Guidance documents released!

The new MDCG documents offer guidance on state of the art of COVID-19 rapid antibody tests, provide Q&A on Custom-Made Devices & considerations on Adaptable medical devices and Patient-matched medical devices and clarify the application of transitional provisions for certification of class D IVDs according to IVD-R 2017/746.

The importance of R&D in medicinal testproducts

Due to COVID, detection tests have been a hot topic for over a year now. Few people realize, however, that these tests are in fact high-tech products, supported by extensive Research & Development. FOKUS therefor interviewed Dirk Stynen, to get a better insights on the process behind the R&D process. (Dutch article)

Should Design and Life Cycle Management of an eIFU Solution Follow EN62304?

An eIFU solution has to comply with many requirements. But what about the application of Design Control and Life Cycle management? Shall your eIFU solution comply to the strict rules of EN62304?

Management of Legacy Devices in EUDAMED!

On 15 February 2021, the European Commission published a document explaining how and when Legacy Devices will be identified in the new EUDAMED database and the way the different Unique Device Identifiers for the Legacy Devices will be generated/assigned.

MDCG 2021-1 What to do while EUDAMED is being built!

On 26 February 2021, the European Commission released MDCG 2021-1 Guidance on harmonised administrative practices and alternative technical solutions until EUDAMED is fully functional.

EUDAMED Actor Registration Module LIVE!

The European Commission launched the EUDAMED Actor Registration Module. Manufacturers, Authorised Representatives and/or Importers can now register in EUDAMED and obtain their Single Registration Number (SRN).

Qarad's 5th IVDR Conference - Oct. 13 - 14, 2021

Due to the COVID pandemic, our annual conference was delayed with one year. In 2021, we are once again ready to inform you about the latest insights in the IVD Regulation 2017/746.

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