New flowchart on the scope of MDR legacy period extension

On 23 August 2023, the European Commission has released a new flowchart to assist manufacturers in deciding whether the MDR transitional period extension covers a device. This extension, which we have covered in a previous post, removes the sell-off provision under MDR and IVDR and extends the transitional period for legacy devices to the following dates:

  • 26 May 2026 for class III implantable custom-made devices, provided the manufacturer has applied for a conformity assessment before 26 May 2024.
  • 31 December 2027 for class III and class IIb implantable devices, except sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors.
  • 31 December 2028 for class IIb devices other than those mentioned above, Class IIa devices, Class I devices placed on the market in sterile condition or having a measuring function, class I devices that will need to involve a notified body for the MDR conformity assessment (up-classified devices)

Flowchart to understand legacy period

The flowchart is divided into two parts, one focused on:

  • Legacy devices covered by an AIMDD or MDD certificate before 26 May 2021
  • Legacy devices that did not require an AIMDD or MDD certificate but will require an MDR certificate and have a declaration of conformity drawn up prior to 26 May 2021

On the other hand, the second part of the document refers to Class III custom-made implantable devices:

Related to the MDR legacy period extension the European Commission has also released a Q&A document and an updated MDCG guidance on significant changes.

You can consult this and other relevant documents in our Library of documents – European Commission section!

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