There are three chapters, and they each have various requirements. They have 23 main requirements, but they have up to 200 considerations. So it is possible for you to have one requirement that then has another 10 sub requirements, or another 10 sub considerations. Manufacturers need to go through the entire 23 main requirements, the three chapters of the GSPRs, and then demonstrate which ones are applicable and which ones are not applicable. For the ones that are not applicable, you have to justify why you think they are not applicable. The notified bodies will be looking out for these statements as well. Keep in mind – not all requirements will be applicable to one particular medical device.
If it’s not sterile, or it’s not emitting radiation, there will be certain areas that will not be applicable to your product. So you have to go through that, and then make sure that you are clearly stating which of these 23 points are applicable, and which ones are not applicable, or the considerations.
In summary, I just want to give you an overview of what these three chapters are talking about. So I’ve broken that down by chapters 1, 2, 3 and we’ll give you a brief overview of what’s going on in each.
Chapter 1: You’ve got your general requirements, which has 9 main requirements with up to 20 considerations. Now you are to assess the safety and performance elements of how you have designed and manufactured the device, taking into consideration its intended use. So right from the very beginning, you have to consider the intended use, how safe it is, and its performance.
You also need to consider risk management according to ISO 14971, its latest addition at the moment is the 2019 version. Make sure you analyze your risk of events. You evaluate them, you score it, you then control, mitigate, and reduce the risk, and then you evaluate your residual risk. You must define your risk – you are putting measures to reduce it, or to get rid of the risk. And then afterwards, you have to analyze again, you have to evaluate, and find out if you have any residual risk? That’s the review element. And then, you also have to consider your production activities and your post production activities, and then your risk elements associated with that, and then also factor those ones into your risk management.
Chapter 2: This chapter talks about your chemical, physical, and biological properties of the device element. It has 13 main requirements with up to 103 considerations. In this instance we are talking about your design and manufacturing considerations, and choice of materials. Why have you chosen a particular material, the compatibility of any moving parts, and from material A to material B, are these two materials compatible with each other? What are the mechanical properties of these materials? You must be able to state all of these, why you’ve chosen it and its mechanical property. When it comes to toxicity, certain plastics or certain elements getting into contact with the skin, they could have a reaction with the skin.
Chapter 3: This chapter is related to the information supplied with the device. This could be labels that need to go onto the device, or it could be the information for leaflets. It has one main requirement with up to 65 considerations. And these are the things that you need to consider for the labeling of the device and for the information that’s going with the device. There is the sticky situation though for combination products where we have seen that the medicinal side will have your primary mode of action. If you have experienced this, the competent authority usually doesn’t allow a lot of your medical device information to be included on the outer packaging for various reasons. So you have to consult with your MPD – your medicinal product directive and where there are differentiations. I would advise you to go with your medicinal product directives requirements when it comes to labeling.