Regulations for IVDs have remained passive in comparison to those for drugs and medical devices for several years. In Vitro Diagnostic Regulation (IVDR 2017/746) under European regulations will make the system predictable and robust through transparency and maintain sustainability.
Recent data shows that under the IVDD only 10-20% of the IVDs are scrutinized by the Notified Bodies. With the introduction of the IVDR, it will rise to 80-90% thereby simultaneously increasing the number of Notified Bodies to review the IVDs.
Thoroughly assess each of your products and collect existing data on QMS, Technical documents, Product data, Labelling, Performance, and Stability.
Segregate products that are more profitable through product classification and the gap analysis already mentioned. Plan ahead to close the gaps.
CE marking by a Notified body is essential to get qualified as an IVD under EU. Accumulate all the documents that might be necessary in the process.
IVDR covers the entire product lifecycle with continuous evaluation. Technical Document needs regular assessment and new norms to be followed to monitor and report post-market performance.
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