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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

Topics Addressed:

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.


Dr. Frank Pflüger is a Partner in Baker McKenzie's Frankfurt office.


Els Janssens is a Counsel in commercial law, litigation and healthcare regulatory issues in the Brussels office. Els worked as a senior regulatory legal counsel for Johnson & Johnson supporting the company's global safety operations and advising on regulatory issues in relation to specific medicinal products. Els also worked as legal advisor in the European Medicines Agency where she advised management, scientific committees, CMD(h) and the European Commission on a wide variety of issues in connection with authorisation procedures, submission requirements, pharmacovigilance obligations and procedures as well as inspections. Based in Abu Dhabi from 2014 to 2019, she advised both multinational medical devices and pharmaceutical clients on healthcare regulations in the EU and UAE.

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