How should a company communicate to its Notified Body about timing for transitioning and implementing to ISO 13485:2016 and the new regulation? Is it appropriate to communicate using a change notification? Is there a standard process?

An upcoming surveillance or recertification audit would be a good opportunity to discuss timing. If a recertification audit is approaching and you want to transition to ISO 13485:2016 during that audit, reach out to them now to ensure they have the resources allocated for an audit to the new requirements. Our sources have suggested it will take approximately eight months to get a MDSAP/ISO 13485:2016 audit on the schedule. None of the Notified Bodies have been recertified to the MDR, so there are at least nine to 12 months before they can consider certification against the MDR. I suggest asking whether they plan to apply for recertification including your types of devices so you know whether to consider changing Notified Bodies.