The transition from the legacy regulatory framework to Regulation (EU) 2017/745 (MDR) represents one of the most complex challenges for the medical device sector. In this landscape, regulatory stability is essential to ensure that products remain available on the market. A recent and long-awaited confirmation comes from the Position Paper, which offers a critical solution for manufacturers: the possibility of changing Notified Bodies (NB) without compromising the benefits of the transitional period.

THE CONTINUITY OF LEGACY DEVICES

Until now, many manufacturers lived in fear that transferring an MDR application to a new body could invalidate the so-called “written agreement.” This document is the legal pillar that allows “legacy devices” (devices compliant with the old directives) to remain on the market during the transition. However, the guidance clarifies that transferring the Formal MDR Application is feasible, laying out a safe pathway to maintain the validity of the extension.

THE THREE CONDITIONS FOR TRANSFER

However, the transfer is not automatic; it requires strict compliance with three technical requirements. First, the official termination of the previous contract must take place. Second, timing: the signing of the new agreement with the incoming Body must occur simultaneously with the closing of the old one. Finally, the key element is the Tripartite Agreement—a formal document signed by the manufacturer, the outgoing NB, and the incoming NB to coordinate the transfer of responsibilities.

STRATEGY AND OPERATIONAL CONTINUITY

This regulatory shift provides unprecedented strategic flexibility. Manufacturers can now optimize their certification processes and select the partners best suited to their industrial needs without the risk of a market freeze. Operational continuity is thus preserved, ensuring that medical innovation is not halted by purely administrative constraints.

ECM has the capacity as a Notified Body (NB) to accept MDR applications from manufacturers of legacy devices.

Contact our Sales Managers today:

Eng. Diego Stevanella  diego.s@entecerma.it    (+39) 3932471040

Marzia Pellegrini  marzia.p@entecerma.it  (+39) 3920710386