About 90% of all manufacturers of in vitro diagnostic devices (IVD) cannot benefit from the transition period stipulated in Article 110 of Regulation (EU) 2017/746 (IVDR) and have to be ready for the IVDR in May 2022. The new regulation will replace the current Directive 98/79/EC on in vitro diagnostics from May 26, 2022.
The most important change is the involvement of an independent notified body for the majority of IVDs , including a conformity assessment procedure lasting around a year. Only 8% are already subject to control by a notified body. Accordingly, a considerable amount of work as well as new tasks and regulations are coming up for the IVD manufacturers.
The creation of IVDR-compliant documents is becoming increasingly important in order to be able to successfully complete the assessment process.
Although the European e Commission recommends extending the scope and timeframe of the transitional provisions, time is running out anyway. The proposal for an amendment to Regulation (EU) 2017/746 provides details .
Are you facing the challenge of IVDR preparation to keep CE Mark for IVDs?
Contact us for individual support and cooperation.
Would you like to concentrate on your business and not on the regulatory obligations?
We are your partner for IVD regulation service and can of course also take responsibility.
Your contact person:
Miss Stamm
senior consultant
+49 251 928715-67
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