Want to know the adopted practise from covers, if the principles for Risk analysis as per ISO 14971 is required when simple plastic parts for medical devices are manufactured in the plant ?

My question is particularly targetted with reference to the Risk management File, plan, evaluation, Risk management Report etc.

I don't know specifically on the standard you are referencing but for Automotive plastic parts we have to do everything the same as metal parts.

Again not being familiar with that standard I can not give you a definite answer, but as a broad answer I would say no matter the medium you need to follow the standard.

Want to know the adopted practise from covers, if the principles for Risk analysis as per ISO 14971 is required when simple plastic parts for medical devices are manufactured in the plant ?

My question is particularly targetted with reference to the Risk management File, plan, evaluation, Risk management Report etc.

I am not familar with ISO 14971, but you would probably need a documented justification as to why you do not perform the risk analysis.

Phil

The scope of the ISO 14971 states - This International Standard specifies a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.

Therefore, I was thinking that plastic parts can not be termed as "medical device" as they are just components but there are some people whom I met are of the opinion that the entire Risk Management aspects should be followed.

On another note, we perform risk management techniques like the FMEA.

The plastics are part of e medical device you manufacture? Or you manufacture just parts?

Therefore, I was thinking that plastic parts can not be termed as "medical device" as they are just components but there are some people whom I met are of the opinion that the entire Risk Management aspects should be followed.


From what I've seen and we've done, you are correct. The focus of 14971 is on the device, not the piece-parts.

Annex G of 14971 (:2007, by the way) lists techniques that CAN be used in risk assessment, but it doesn't prescribe particular methods. One method they describe is the FMEA which can be used to analyze component failures. It's pretty clear though that, in the end, the safety of the device is what's determined. That is clearly indicated by the residual risk evaluation and the evaluation of overall residual risk acceptability required by 14971. How you get there is part of your Risk Management plan.

The plastics are part of e medical device you manufacture? Or you manufacture just parts?

I was referring to the manufacture of the plastic parts alone. For some customers, we make the device but for others, we just make some plastic parts and are shipped to customer.

Most importantly, the definition of a medical device is any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of : (i) diagnosis, prevention, monitoring, treatment or alleviation of disease, (ii) diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or handicap, (iii) investigation, replacement or modification of the anatomy or of a physiological process, (iv) control of conception, and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means.

In this context, it maybe just a simple plastic part to one but it could be an important part or article to a completed finished medical product. So, never tkae it lightly that one man's meat is not another man's poison! It is necessary to study the risk of this simple plastic product to justify whether it is a risk to the whole process of the inteneded product to be used by the customer and end-users. If necessary, review the Annex A of MDD requiremnets to identify the route to seek if is necessary to construct a risk management plan.

My opinion in more in line with the opinionof Silverhawk. In fact, supplier risk management system parity is a trend in the industry (as is suplier quality management system parity on ISO 13485) so it can be expected that someday you will need to have a risk management of parts instead of just the whole device (in this case the part risk management would be an input to the finished device risk management).

Risk management is a requirement of 13485, which can be held by subcontractors and service suppliers, so yes you should incorporate RM across all of product realization, even if you don't work on the finished device.

Clearly the depth you would need to go into might well be less than for a finished device maufacturer, and some of the more detailed approaches within ISO14971 might not be appropriate.

Edit: And as has been pointed out, your company may be asked to contribute to a higher-level risk management report compiled by the finished device manufacturer.