If you manufacture a medical device that is CE marked, you are required to comply with the latest MEDDEV 2.7.1 publication. This revision is a major rewrite from the previous publication of Rev 3 as the authors sought to bring clarity and layout stricter expectations for Clinical Evaluation Reports (CERs). Compliance expectations ultimately fall on the manufacturer, and the Notified Bodies are being given greater responsibility in enforcement as they perform audits.
Rev 4 is 50% larger than its predecessor because of the level of detail. Fortunately, the document was written by many of the same people who wrote the latest MDR requirements published in May of 2017 so we hope to see these documents aligned. It is anticipated that there will be a gap analysis performed after MDR is fully implemented. After this, we can all look for a Rev 5.
Several MEDDEV 2.7.1 Rev 4 description changes that are required
There are several excellent descriptions of the changes required, and here are a few.
This article is from BSI – a top tier Notified Body: https://www.bsigroup.com/meddev/LocalFiles/en-GB/Documents/BSI-md-meddev-271-clinical-guidance-brochure.pdf
And these are from top tier industry consulting groups: http://resources.rqteam.com/registration-rq-intelligence-series-on-demand-webinar-may-2017
So, what does MEDDEV 2.7.1 Rev 4 mean for my clinical and regulatory teams?
The goal is to bring more clarity and tighter expectations for Clinical Evaluation Reports, so this means teams will have to re-evaluate the current conditions.
What about for both new submissions and required updates???
In short, more work, and more expensive people doing the work.
Contact the Waddell Group Today
We provide strategic level project leaders for the medical device industry. Beyond essential project management skills, our highly experienced consultants know how to lead teams, manage in times of crisis, and influence change. If the MEDDEV revisions is a concern for you and your company – we can help you put together a Gap Analysis and help manage the increased workload. Please contact us at rich.gall@waddellgrp.com or call us at 952-221-3333.