Importance of Clinical Evaluation
ISO 13485 7.3.7, Validation of Design and Development, has the following requirements
As part of the design and development validation, the organization will conduct a clinical or performance evaluation of the medical device in accordance with applicable regulatory requirements.
Clinical evaluation” is mandatory for medical devices, and “performance evaluation” is mandatory for in vitro diagnostic products.
Why is clinical evaluation important?
Medical devices are intended for use on humans, so it is only natural that their safety and efficacy should be evaluated through clinical evaluations.
Clinical evaluation is important to ensure that the safety and performance of medical devices are continually assessed throughout the life cycle of the device in the market based on sufficient clinical evidence.
Why is ongoing clinical evaluation necessary?
The MDR (European Medical Device Regulation) has tightened requirements regarding PMCF (post-marketing clinical follow-up).
In MDR, PMCF plans and other documents are counted as one of the technical documents and must be properly prepared, maintained, and followed.
We observe that many medical device companies have decided not to implement PMCF.
However. In the design and development of medical devices, there are cases where the residual risk is not acceptable and development is driven by the risk/benefit ratio.
However, it must be remembered that the risk/benefit ratio assumed during the design and development of a medical device will change over time.
Because, in post-marketing of medical devices,
・Benefit (effectiveness) will only go down.
・Risks only go up. (Discovery of new hazards)
This is why.
In other words, better therapeutic or diagnostic techniques may be invented or substituted by the development of pharmaceuticals or other products than at the time the medical device in question was designed and developed. This will result in a decrease in benefit.
On the other hand, it is unlikely that the risk will decrease, but rather new hazards may be discovered that were not anticipated at the time of design and development. In other words, the risk is higher than when the medical device was designed and developed.
Accumulation of clinical knowledge is essential to know the latest risk/benefit ratio. The state of the art also changes, so the latest safety information (e.g., similar products), regulatory requirements, international standards, and common specifications must be incorporated.
The ongoing clinical evaluation process necessitates that manufacturers constantly evaluate the risk/benefit ratio of their devices throughout their lifecycle and refine them as needed.
In the future, the implementation of PMCF will be mandatory for the development of new medical devices unless the risk management is complete and perfect.
IEC-62304 compliant] Sample of regulations and procedure manuals goes on sale.
(Click here for samples [Regulations] and [Procedure Manual])
In this country, IEC 62304 (Medical Device Software – Software Lifecycle Processes) became a substantive regulatory requirement as of November 2017.
IEC 62304 was published in May 2006 and JIS-ized (JIS T 2304) in Japan in 2012.
The U.S. FDA also recognized it as a Recognized Consensus Standard in July 2008.
IEC 62304 specifies processes for the development and maintenance of “medical device software”.
Outside of Japan, evidence of software development based on IEC 62304 is required for medical device applications in Europe, North America, China, and other countries.
In other words, without developing “medical device software” in accordance with IEC 62304, medical devices (including stand-alone programs) equipped with software cannot be sold in Japan or abroad. However, IEC 62304 is very difficult to understand. What exactly should we do?
In general, process standards such as IEC 62304 are interpreted in different ways by different companies, resulting in very different procedures.
・Even after reading IEC 62304, I don’t know what I need to address or how to do it.
・After reading IEC 62304, I don’t understand the scope of how far I should go.
・The details of IEC 62304 are still unclear in the construction of the document.
We receive many questions such as.
By introducing this “Model for IEC 62304 Compliant Regulations and Procedures,” you can efficiently and effectively create a QMS that complies with IEC 62304.
]]>
Comment