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.

Internally, you need to be sure your QMS has corresponding interfaces.  First is in your change management process whereby you need to screen changes against the NB’s notification requirements.  For those changes that meet the regulator’s (e.g., the NB’s or other agency’s such as Health Canada’s) notification thresholds, I have in the past set up a database and form to record such changes in a strategic way for presentation to the regulator for this context.  Then these strategic record(s) of change(s) are submitted to the regulator (e.g., the NB) in accordance with its applicable procedures and timelines that will be in your contract.