Team Notified Body (NB) has issued another Position Paper this week. This paper is on transition timeframes to implement new MDCG guidance and best practice documents into their procedures, located: HERE
The purpose is to establish a consistent approach between the Notified Bodies. As a result, manufacturers will be subject to similar expectations, irrespective of which Notified Body they select.
Per the Position Paper, Notified Bodies will take the following time to implement new MDCG guidance and best practice documents:
- Up to 4 months from MDCG guidance publication date to complete a thorough gap analysis
- Up to 8 months from MDCG guidance publication date for a full impact assessment and updates to QMS documents, IT systems, processes etc
- Up to 12 months from MDCG guidance publication date for roll-out of the changes including staff training
This is in line with the MDCG’s recent notice that new guidance should not be immediately applied to ongoing processes or applications already launched, unless use of such guidance increases the efficiency of the CE Marking process.
Why does this matter to you?
This is part of the MDCG’s attempt to increase Notified Body capacity, reduce regulatory burden and ensure manufacturers have adequate resources to CE Mark under the MDR/IVDR, as reported: HERE
These new implementation timeframes help companies already in the Notified Body CE Marking process. Manufacturers will not have to pause the project in order to incorporate new guidance or best practice documents — unless the new guidance helps expedite the CE Marking process. It helps prevent project stalls and pushes the CE Marking process forward.