On May 5, 2017 the EU MDR (Medical Device Regulation) was published in the EU Official Journal. This date starts the three-year mandatory transition period where the MDR will replace the MDD (Medical Device Directive). The expanded scope of the MDR combined with the time frames for compliance is compelling medical device companies to focus significant attention on transition strategies and will require substantial hands-on work.
R&Q recently presented the webinar, EU MDR: Assessing the Impact and Next Steps. During the session we answered several of your questions, a sample of which are below. To see all of the questions and answers from the session, along with the slides and recording, check out the on-demand webinar.
Q: How should a company communicate to their NB about timing for transitioning and implementing to ISO 13485:2016 and to the new regulation. Is it appropriate to communicate using a change notification? Is there a standard process?
A: If you have a surveillance or re-certification audit coming up that would be a good opportunity to discuss timing. If you have a re-certification audit coming up and want to transition to ISO 13485:2016 during that audit, you would reach out to them now to ensure they have the resources allocated for an audit to the new requirements. Our sources have suggested that it will take approximately 8 months to get a MDSAP/ISO 13485:2016 audit on the schedule. None of the NB have been re-certified to the MDR so we will have at least 12-18 months before they can consider certification against the MDR. I would suggest asking them if they plan to apply for re-certification including your types of devices so you know if you have to consider changing NBs.
Q: Does the CER (MEDDEV 2.7/1) have a transition period or does all CER have to be in compliance with the new MDR per June 2017?
A: MEDDEV 2.7/1 rev 4 was written to address variations in the quality of clinical evaluation reports under the directive. adopting best practices Our conversations with Notified Bodies have indicated that if you have a plan in place to bring your CERs into compliance with the new guidance that is sufficient at this time. As the regulations are adopted the expectation is that a new MEDDEV will be issued that will align with the MDR. The best first step is to bring your procedure up to the current standard and issue a quality plan that outlines how and when you will bring your new and revised CERs to current standards.