EU Commission Factsheet for IVDR

EU Commission issued a Factsheet for Manufacturers of In-Vitro Diagnostic Medical Devices.

If you still not defined your strategy for transition to IVDR (EU 2107/746), you may benefit from the factsheet issued recently by EU commission.

Although the date of application of the IVDR is 26 May 2022, the high number of changes within the requirements makes the early preparation very important. Defining the new risk classification of your IVD and suitable conformity assessment procedure would be an excellent starting point. Manufacturers may benefit from a gap analysis and a detailed action plan, which may be prepared afterwards.

You may reach the fact sheet issued by the commission from this link.

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