January 11, 2024
Notifying Your European Notified Body About Non-Significant Changes
Europe’s Union MDR (Regulation 2017/745) includes legislative authority (e.g., in Annex VII sec. 4.9) for Notified Bodies (NBs) to require a manufacturer to notify the NB about certain kinds of changes [e.g., QMS, product range, device design (including labeling), intended use or claims, type, and chemical substances) without clear regard to significance. This is to enable the NB to assess the impact. Because that includes a concomitant requirement for the NB to have in place corresponding documented procedures and contractual arrangements, you should be sure you understand your particular NB’s change notification requirements by reviewing your NB contract to see about the possibility for negotiation and to double check that any of the NB’s related requests are within the parameters of the contract. The best time to negotiate is before the contract is executed. Once executed, it is more difficult to realize deviations if either party doesn’t like what’s in the contract.