The EU Commission has released an informative Q&A document intended to provide guidance on the implementation of the extended transitional period provided for in the IVDR, as amended by Regulation (EU) 2024/1860 of 13 June 2024 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards a gradual roll-out of EUDAMED, the obligation to inform in case of interruption or discontinuation of supply, and transitional provisions for certain in vitro diagnostic medical devices
The Q&A document contains a total of 18 questions that are split across the following 5 sections:
- Part A: Scope of the Extension of the IVDR Transitional Periods
- Part B: Evidence of the Extended Transitional Period
- Part C: Conditions to be Fulfilled to Benefit from the Extended IVDR Transition Periods.
- Part D: Appropriate Surveillance to be Performed by Notified Bodies
- Part E: In-House Devices: Justification Regarding Non-Availability of an Equivalent CE Marked Device.
The document also features a flowchart in the appendix, which is intended to assist manufacturers and other relevant actors in deciding whether or not a device is covered by the extended transitional period provided for in Article 110 of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR), as amended by Regulation 2024/1860.
The Q&A document can be accessed using the following link
