Guidance on software classification & other documents

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The European Commission indeed works hard to provide further clarification on a number of aspects. Documents are now being issued frequently. It is great that long awaited clarification is being provided! However, stakeholder criticism is that some of the MDCG documents not only clarify aspects, but rather restate the requirements.  Another fear is, that additional requirements are being introduced with the clarification instead of providing just the needed clarifications. These two aspects may become obvious when you would apply them. We certainly would appreciate feedback regarding this matter.

In any case, those documents, if they apply to your products or system, should be considered. For example the new software guidance is very important to support your classification for your software. That document was published last Friday 2019.10.11.

Here is the list of documents for you to consider:

  • Software – First publication: 2019.10.11
  • Transitional provisions on MDD/IVD certificates – First publication: 2019.10.04
  • Call for expression of interest for expert panels – First publication: 2019.09.30
  • Manufacturer Incident Report (MIR) Form – Last update: 2019.09.30
  • Guidance on the vigilance system – First publication: 2019.09.26
  • Summary of safety and clinical performance – Last update: 2019.09.27
  • Unique Device Identification (UDI) System –  Last update: 2019.08.20

There are more documents to consider and the complete list can be found here.
It is the so called docs room which was offline for quite some time. Now, it is back.

In the past we have recommended to check here for updates but it seems that the docs room is quicker in publishing.