Some companies finished their MED DEV R4 updates while some going through their NB reviews currently. Most of the IIb and III CERs that manufacturers compiled are good with REV 4 but may not be with EU MDR (especially in the areas of Equivalence, if claimed and other areas like SOA and PMCF parts which some manufacturers chose to either skip or not gone deep enough earlier).
Based on some of the rescue projects and remediation fixes we did for some manufacturers, compiled few Queries/Observations found in audits that may help some companies tune their process and approach for CERs
State-of-Art related
- The selection of clinical data for state of the art should be objective and based on the data provided seems more selective and biased on the basis of being favorable for the device under evaluation. Also, information on alternative approaches that are being used is not outlined.
- In SOA mentioned that treatment comparability versus accepted therapy is not available. This has not been described well in IFU
Intended Use / IFU linkage related
- Of all the intended uses described in the IFU, only two fo them analysis was performed in CER. For the other 3 intended uses, how performance, safety and risk/benefit are analyzed is not outlined
- Information regarding warnings and precautions as outlined in updated CER are not brought to the attention of the user on the label or IFU
Literature related
- In the CER, a total of 6 clinical literatures were used to demonstrate medium and long-term restorative effect for equivalent devices. But clinical literatures were insufficient to identify the clinical hazards identified in the risk analysis
- Where is the justification for excluding non-English articles as how do you know that papers in non-English do not have important safety information?
- It is unclear how the number of literature hits from each of the 3 databases searched (221, 112 & 31, 114) were reduced to get to the 26 papers. Please clarify
- The search criteria used was limited to XYZ markers. Generic device type terms such as ABC markers were not included to ensure all relevant scientific literature was identified
Risks / Benefits related
- The CER identified 5 risks. Risk evaluation/control for R4 (optimized with 4 markers. Other complications were higher with 4 markers) could not be identified in the risk management file (RMF)
- A benefit of XYZ in the peri-operative management of patients 14 years and older with severe or moderately severe AABBCC DISEASE seems likely, but the data provided in the interim analysis of the relevant study require confirmation from the results of the completed study before this benefit can be claimed with confidence.
Equivalence
- Equivalence to AABBCC device was claimed. The data provided did not cover the device variants and indications for the defined lifetime of these devices