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.

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.

Brexit and the Impact on the IVD and MD Industries

The United Kingdom (UK) leaves the European Union (EU) on January 1, 2021. Manufacturers wanting to begin or continue business within the UK need to understand the implications of this move and should start making preparations today.

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).

MDCG Guidance on IVDR Classification Rules released!

On 13 November 2020, the European Commission released MDCG 2020-16 Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746 (IVDR).

UDI FAQ

The European Commission has published a Q&A document explaining how the Unique Device Identification (UDI) system will work under the EU medical devices Regulations 2017/745 and 2017/746.

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