Plan around MDR and IVDR transition rules

MDR and IVDR transition planning depends on the device, certificate status, conformity route, class, surveillance obligations, and whether the conditions for relying on transitional provisions are met.

Do not assume that a transition period applies just because the product was previously on the market. Upload certificates, notified-body correspondence, declarations, and evidence of ongoing compliance so the expert can assess the position.

Because transition rules and implementation guidance can change, confirm deadlines against current official sources and your expert’s review before making market or submission decisions.