Medical products and software

What is covered by medical products and software?

This includes medical products for therapeutic purposes but also for diagnostic purposes, so software with which a diagnosis is made is also included. In the CE Tool you can determine whether or not your product falls under this Directive, the Medical Devices Directive.

Multiple Directives may apply to your product
Other directives may also apply to a medical product. Is your product a device that is also connected to the mains and also contains electronics then there are multiple requirements applicable to your product. In this case, in addition to the Medical Devices Directive, you also have to deal with the Low Voltage Directive and the EMC Directive. In most cases the Low Voltage Directive is excluded when the Medical Devices Directive is applicable. No worries, because in the CE Tool you can select the right directives that apply to your product without legal knowledge.

CE Tool example: More applicable directives

What is excluded from the Directive?
If you have gone through the above steps, you must first go through the 'exceptions' wizard. Look carefully in those lists if your product is not excluded. Check this carefully and then check whether your product or assembly is on that list or not. In the Medical Device Directive, there are various exceptions such as implantable products, medicines, cosmetics, human blood products, grafts, etc., for example, not covered by this Directive. So just read the 'exceptions' in the wizard on the CE Tool. If you need help, you can send an e-mail to Euronorm Tools.

CE Tool example: Possible exceptions:

Test the safety requirements, the risk analysis
After finishing the 'exceptions' wizard, you should start with the risk analysis. With the risk analysis you determine whether your product or assembly meets the legal safety requirements. A valuation method is also included in the risk analysis. This method is based on the widely used risk graph 'Fine & Kinney'. With this risk graph you can determine whether you have to solve a risk immediately or whether this has a lower priority. In the risk analysis you have to take into account that your customer can misuse your product. You have to anticipate as much as possible and, where necessary, warn in your user manual and on the product.

CE Tool: Risk assessment MDD directive (possibly in combination with other directives)

What should be in the manual?
You are obliged to provide a manual, but what should be included in it? In the CE Tool you will find a list with requirements for the user manual. You can find this file in the 'user manual' folder. If you already have a manual, check whether it meets these requirement. And if not, you can use this file as a guide for drawing it up. If you also make other products that are subject to different requirements, the content of the file is often different. So be careful with that.

What should be on the type plate / CE label?
There are also demands for the type plate or label that you affix on your product. In the folder 'nameplate / label' you can generate an example that meets the legal requirements. Note that the entry fields with * are mandatory fields. If you also create other products in the CE Tool where other requirements apply, then there are often other compulsory fields. So check this file for each product that you create in the tool.

CE Tool example: Creating a type plate / CE label online (You can always adjust it online or in WORD if desired)

The Declaration of conformity?
You also have to provide a so-called 'Declaration of Conformity' (DoC) with each product. In this DoC you declare that your product meets the legal requirements. You can generate this DoC in the Declaration of Conformity folder. Note that the entry fields marked with * are mandatory fields. If you also create other products in the CE Tool where other requirements apply, then there are often other mandatory fields. So please pay attention at that point.

CE Tool example: Creating a Declaration of Conformity online (You can always adjust it online or in WORD if desired)

Which technical documentation must at least be present?
You are obliged to draw up a so-called 'Technical File', but what should be in it? In the CE Tool you will find a list with requirements for your Technical File. You can find this file in the 'Technical Documentation' folder. Please check if your documents meet these requirements. If you also make other products with other requirements, the content of this file can be (very) different. So please be careful that you check the requirements in this file for each product.

Does the product has to be tested?
Whether your product needs to be tested can be found in the 'Test reports / certificates' folder in the CE Tool. There you will find a flowchart with which we show you the best way possible. With medical products you have to deal with a classification of types of products and a series of rules that you have to go through. This can expensive. If you need help, you can send an e-mail to Euronorm Tools.

Document control
If you have gone through the above steps, it is always possible to have your CE file checked by us. We then indicate whether you have completed all points sufficiently.

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