The selling-off period or the interim between the certificates
The MDR has now become a reality for most manufacturers, importers and distributors in the medical device industry.
Yet in practice, there are internal and external factors that can inhibit implementation in the company and thus upset the timetable on the way to the MDR certificate. What do I do now when the old MDD certificate is about to expire and the new MDR certificate is still waiting? How do I deal with the products that I still have in stock?
There are options for ensuring the continued usability of medical devices of classes Is, Im, Ir, IIa, IIb and III produced within the validity period of the MDD certificate. It depends on when these devices were placed on the market. If they leave the sphere of the manufacturer towards the EU, the placing on the market occurs. This happens through a transfer of ownership of the product. This can already take place through contractually binding agreements; a physical handover does not yet have to have occured. Thereafter, for some products a so-called "sell-off period" allows the further provision and putting into operation of the product. This period may last until 27.05.2025 (see MDR Article 120 (4)). As so-called "legacy devices", the devices in question have already some MDR obligations that must be observed (among others, registration in EUDAMED, designation of an importer according to Art. 13 MDR, vigilance obligations, etc.), but they are still commercially viable. This can be crucial for the commercial usability of these products. In addition, this can also be of great importance from a sustainability and supply security point of view.
Kalms Operations has set up a program to evaluate with international manufacturers whether and how they can use this sell-off period for their products whose MDD certificates are in danger of expiring and/or for which no direct transition with a new MDR certificate is assured. Together we will evaluate which possibilities there are in your individual case to be able to commercially exploit your stock. Make an appointment with our specialists or meet us at MEDICA 2022 from November 14-17, 2022 in Hall 15/ Booth 22 in Düsseldorf, Germany.
On the author: Gerald Schröder is an Executive Vice President and Head of the Kalms Operations Business Unit at Kalms Consulting GmbH. He has also completed an additional qualification as "Manager Regulatory Affairs Medical Devices International (TÜV Rheinland & Ulm University of Applied Sciences)"..