Confused about Sufficient Clinical Data as per MDR Article 61
Clinical data is all information related to safety and performance of device that is generated by using the device. This could be data from
- clinical investigations of the device under evaluation
- clinical investigation or other studies reported in the scientific literature, of a similar device for which equivalence to the device in question can be demonstrated
- published and/or unpublished reports on other clinical experience of either the device in question or a similar device for which equivalence to the device in question can be demonstrated.
Question 01: Are the devices include sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips or connectors for which the clinical evaluation is based on sufficient clinical data can any one help me understand what is Sufficient Clinical Data
Question 02: If the product not coming under point 1.7 and the clinical data not deemed to require for the demonstration of conformity with the GSPR, then is there adequate justification in any sort to be provided?
1. Yes, for above mentioned devices, clinical evaluation is based on sufficient clinical data.
Sufficient clinical data defined as data related to the safety, performance and side effects of the medical devices as per its intended use from the clinical trials conducted on humans for the subject device, similar device or equivalent devices.
Sources of sufficient clinical data includes
1. Published data
• Scientific Literature Database
• MEDLINE or PUBMED
• COCHRANE CENTRAL Trial Register
• PDQ Evidence
• TRIP
• Google Scholar
• FDA
• Clinical trial.gov
• Prospero international prospective register of systematic reviews
• Manufacturer website
2. Non-published data
• Label and IFU
• Implant Registries information
• Data presented in Congresses
2. Yes, there should be adequate justification if clinical data not deemed to require for the demonstration of conformity with the GSPR and product not coming under point 1.7.
As per clause 10, Justification should be based on the consideration of the specifics of the device and the human body interaction, the intended clinical performance, manufacturer’s claims and risk management results.
In this case post marketing studies or PMS given weightage for the devices that are already in market.