Hi All,
As Dr.Simon mentioned about Tech file:
It is a Comprehensive collection of information and documents, Contains Details everything about a medical device, Less complex for MDD Class I and more complex for the others.
A technical file is much closer in nature to a 510(k) than a design history file; it’s basically the European version of the 510(k). It is required to get your device into Europe and several other parts of the world.
According to this week lecture and what we have learned in the last semester, what do you think about Tech file & 510k, differences and similarities, which one easier to submit?
For example:
It is easier to change things in Tech file and contact Notified Bodies (NBs) with any change.
Also, one big difference with a technical file versus a 510(k) submission is the need to provide a clinical evaluation report. A clinical evaluation report addresses the product’s clinical investigation, risk, and outlines any post-market clinical follow-up studies that may be necessary.
Remember as we discussed in Medical Device Development, even if something goes through the 510K process in the US, it still undergoes design controls and has its own DHF. Wanted to clear that up before anyone got confused.
Spiral Medical Development
www.spiralmeddev.com
One of the similarities between the technical file and a 510k submission is that both of these submissions must be reviewed and approved by the appropriate authorities before the company can market the device. In the case of the technical file in the EU, it is subject to review by a Notified Body, and in the case of the 510k in the US, it is reviewed by the FDA. Another important difference between the technical file and the 510k submission is that in order to compile a technical file, your device must have gone through design verification and validation, whereas a 510k can be submitted when the device has only gone through design verification (see source below).
https://www.greenlight.guru/blog/technical-file-vs-510-k-vs-design-history-file-dhf
One of the main differences between 510k and a technical file is the risk management file. Although, ISO 14971 requires a risk management file to be submitted regardless of where the medical device is being sold. The US FDA doesn't require a risk management file as part of the 510k submission. The US FDA only requires it if the device contains a software and the risk is at least a moderate concern. It can be argued, that each company is required to perform a risk analysis on their product, however it is not required to be submitted with 510k
Another difference between 510k and a technical file is the submission of a clinical evaluation report. All devices with a CE marking must have a clinical evaluation report. It is an essential requirement in Annex I of the Medical Device Directive. It is surprising to know that even Class I devices need to submit a clinical evaluation report. While only 10-15% of 510k submissions have clinical studies.
Another difference between 510k submission and a technical file is that the 510K is for Class II and above in the US. Whereas the technical file is required regardless of the class of device in the EU. The path to get a device to market in EU is dependent on class, so its crucial to be able to classify your device early on. In the EU, if your product is Class I or IIa, you may be able to self-certify but you will still need authorized representatives to legally represent your product at market.
As mentioned in lecture, Authorized Representatives must reside in the EU, only need one per company, act as the contact point for the CAs, and private companies can act as authorized reps.
https://www.greenlight.guru/blog/technical-file-vs-510-k-vs-design-history-file-dhf
CE technical file and 510k are ensuring that medical device manufacturers produce and market safe products that comply the applicable regulation.Difference with CE technical file and 510k submission is need to provide clinical evaluation reports.To put together technical file design verification and validation is required where as for 510k onl6 design verification is needed.Another point of difference ,the CE technical file is required regardless of class of device in the EU whereas 510k is for classii or above in the U.S.
Another notable difference is with post-market clinical follow-up. For the FDA, PMCF is only required for the highest risk devices. For CE Marking, however, all product families are required to have evidence of post-market clinical follow-up studies or a justification for why post-market clinical follow-up is not required.
There are big differences between the Design History File, 510k Submission, and the Technical File. The design history file is an FDA regulation that talks about the design controls and the changes and additions that have occurred from the time of conception. These files feed into the 510k and technical files but are itself a hefty file of design and development in the safety of the product.
The 510k is a path of FDA clearance that products take that most class II devices take. The point is to demonstrate to the FDA that the product is similar to an already approved product. This is a good way to speed up the process, however, the device is still susceptible to FDA inspection at any time.
Lastly, the technical file is similar to the 510k but used in device approval abroad. The file also requires a clinical evaluation report that addresses the investigation, risk, and post-market information.
