ARTICLE SUMMARY:
Having just seen the implementation of the new MDR in Europe earlier this year, diagnostics companies need to get ready for next year’s introduction of the IVDR. Here are some specific steps that companies can take to ensure they are prepared for the impending new regulations. Patrick Brehm, Veeva MedTech Europe.
The in vitro diagnostics (IVD) industry has been caught between a rock and a hard place. The global pandemic has required that sector’s full attention. In parallel, Europe is pushing forward the modernization of its IVD regulations (the impending In Vitro Diagnostic Regulation, IVDR), away from the current list-based path to the rule-based approach that has governed medical devices and diagnostics for decades. This regulatory change could lead to a 10-fold increase of IVDs requiring notified body certificates to enter the European market.
