What manufacturers/importers should know and do, to secure commercialization of legacy products
Manufacturers and EU importers of medical devices are periodically confronted with new sets of rules imposing new product conformity requirements. Apart from MDR/IVDR, also other EU legislation as well as revisions of ISO standards may compel companies to secure future marketability of legacy products on stock before the expiry of transition periods. For taking advantage of transition mechanisms, EU legislators regularly require that affected products have to be “placed on the market” prior to a cut-off date. But what does that mean, and how should companies practically implement and record a “placing on the market”? We will to address those questions in a
Webinar on 13 July 2022 at 17:00 CET
(= 11 AM U.S. EST, = 8 AM U.S. PST)
Duration: 45 minutes // attendance free // Q&A session included
Recap Art. 120 MDR; 110 IVDR transitional periods
- Cut-off dates of May 26, 202X
- Other deadlines for “placing on the market”
Placing (and making available) on the market
- MDR/IVDR definitions; impact of the ‘Blue Guide’
- Commercial offer / agreement / transfer of possession
- Physical and legal transactions – inter-company transfers
- Invitation to purchase, advertising campaigns sufficient?
- How to record transactions demonstrating a “placing on the market” (for inspections and audits)
We will use Zoom as the presenting platform for this webinar. To register, click on the REGISTER button above. Please feel free to forward this to any of your colleagues who may be interested.