Seed (7743) · RiskMaterialised
Risk to Continued Overseas Sales from Europe’s Transition to MDR
First written in FY2020. 1 of 2 entries say "Materialised", first in FY2023. Latest entry: FY2023.
2entries
4years
0from disclosures
How it moved
Same theme, other companies
Adaptation of medical device production and export systems in response to the EU MDRA theme 3 companies write about · 2 as a headwind · 1 as a tailwind
Seed moved to the "Worse" side of this theme in 2023.
0 other companies' latest entry also says "Materialised".
Ridges = years it wrote progress, valleys = years it wrote worse. Most hopeful companies at the back. Drag to turn, scroll to zoom, right-drag to pan. On a phone, two fingers turn and pinch to zoom; one finger scrolls the page.
Full recordFilings, disclosures and news, newest first
- FY2023MaterialisedAnnual report
「In the fourth quarter, we recognized valuation losses on inventories built up in Europe in preparation for changes to the European regulatory system, due to the expiration of their shipping deadlines and the discontinuation of the products.」
Valuation losses actually arose on inventories held in preparation for changes to the European regulatory system, due to expiration of shipping deadlines and product discontinuations. - FY2020First statedAnnual report
「The possibility that products for which the transition from the Medical Device Directive (MDD) to the Medical Device Regulation (MDR), the regulations governing medical devices distributed under European standards, was not completed by the deadline may no longer be sold」
The transition deadline from the European MDD to the MDR, the acquisition of new certifications and the impact on continued sales are explicitly identified for the first time as risks specific to overseas certification systems.