Returning from Expodental 2024, let’s take stock of the May 26 deadline for manufacturers who must embark on an MDR certification journey.

26 May 2024 is fast approaching, and for manufacturers of legacy devices, this day represents a crucial deadline. By this date, manufacturers must indeed submit a formal request for MDR certification to a Notified Body, in order to extend the validity period of certificates issued under previous directives (until 31 December 2027, or 31 December 2028).

THE MANUFACTURERS’ PERSPECTIVE

During our visit to Expodental, the International Exhibition of Dental Equipment, Supplies, and Services, we had the opportunity to engage with numerous manufacturers and dental industry professionals. These meetings revealed a growing awareness regarding the impending deadline and the need to act to verify compliance from an MDR perspective.

“The discussion around the MDR Regulation is increasingly present among industry manufacturers,” explains our Sales Manager Diego Stevanella. “It is clear that the 26 May deadline is prompting many companies to move towards certification, but it is essential that this transition takes place in a timely and accurate way, in compliance with the established deadlines.”

GROWING CERTIFICATION REQUESTS

As the deadline of 26 May 2024 approaches, Notified Bodies are witnessing an exponential increase in certification requests, with the imminent risk of saturating their capacity to accommodate new clients. This growing demand is a clear signal of manufacturers’ urgent need to act promptly.

As a Notified Body No. 1282 for the MDR, we at Ente Certificazione Macchine are also receiving an increasing number of certification requests, resulting in extended processing times and the risk of saturating our resources.

“Time is running out and it is essential that manufacturers understand the urgency of the situation. We therefore encourage all potential customers to promptly submit their MDR certification applications, in order to ensure correct and efficient handling of inquiries,” concludes Stevanella.

For further details and information on MDR certification, please do not hesitate to contact our Sales Manager, Diego Stevanella, at diego.s@entecerma.it