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.

ENSURING THE CONTINUITY OF LEGACY DEVICES

Until now, many manufacturers lived with the 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’ (products compliant with the old directives) to remain on the market during the transition. The guideline clarifies instead that the transfer of the Formal MDR Application is feasible, outlining a secure process to maintain the validity of the extension.

THE THREE CONDITIONS FOR TRANSFER

However, the transition is not automatic; it requires strict compliance with three technical requirements. First, the previous contract must be officially terminated. Second, the principle of simultaneity: the signing of the new agreement with the incoming Notified Body must occur simultaneously with the termination of the old one. Finally, the cornerstone 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 BUSINESS CONTINUITY

This regulatory opening 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 commercial standstill. Business continuity is thus preserved, ensuring that medical innovation does not stall due to 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:

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

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