Bringing your product to the market is not easy. Regulatory requirements are a hurdle that has to be taken. MDR/IVDR/FDA are a few keywords here. HTRIC can help you find te way. A few clues are mentioned here.
At Demcon there is a lot of experience with QA/RA in new product development for medical devices. They can help you to understand what you need to do to bring your product to the market.
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If you want to bring a product with a medical classification to the market you need to have an association with a Notified Body.
A notified body is an organisation designated by an EU country to assess the conformity of certain products before being placed on the market. These bodies carry out tasks related to conformity assessment procedures set out in the applicable legislation, when a third party is required.
In the Netherlands today there are only three notified bodies in de medical technology field: DEKRA, KIWA-Dare and BSI.
If you want to bring a medical device to the market, you need your company to be assessed by a Notified Body to see if you fulfill the requirements of ISO 13485:2016 and MDR.
This typically means that you have to have a quality system in place. You can also have a ISO 9001 certificate, but it is not needed if you have ISO 13485.
Note that in some countries other requirements need to be fulfilled, sometimes in the sense of additional certification. For instance USA (FDA), China (CFDA) and Korea (KFDA) ask for additional deliverables.
If your product is a software product that stores patient data you also need to check if you need to comply to ISO 27001:2013
On your product you need to indicate quite a few things. Amongst others you need to show the identification of your Notified Body (a number) next to the CE mark.
But there are many more requirements, e.g:
- Product name
- Product’s lot number or serial number
- All details needed for a user to identify the device, the contents of its packaging and the intended purpose of the device
- Contact details of the manufacturer (e.g., name and address)
- The UDI (Unique Device Identifier) which you need to register!
- An indication of any special storage or handling conditions
- If the product is supplied in a sterile condition, an indication of its sterile state and method of sterilisation
- An indication if the product is for single-use
- An indication if the device is custom-made or intended for clinical investigation only
To be able to sell your product you need to declare that it fulfills all necessary requirements. You do that in a Declaration of Conformity.
To make sure you do fulfill all these requirements you need to perform and document tests. If your company certification allows for selfcertification you can do it yourself. If not, you need to have your tests assessed by your Notified Body. In some cases you have to have your tests done by a certified test agency. For instance if you do not have the test equipment in house. Think for instance about EMC.
If you want to sell your product in the USA, you need to comply to the FDA requirements.
For example your company needs to comply to 21 CFR 820. It is similar to ISO 13485:2016 but not exactly the same. The good news is that the FDA will in the future move to ISO 13485 as well. there is a document that compares both standards: AAMI TIR102:2019.
A crucial element of your development process is Risk Management, There is a Standard describing the requirements: ISO14971:2019
Instruction for use and language requirements
In Article 41 of the MDR you can find what the requirements are: in short if you sell/ship to a country the local language should be available.
You can find more requirements for your manual in MDR Annex I Chapter 3
You need to register your medical device in de UDI database.
Your company needs to have an identifier as well as your product. MDR Annex VI gives you the requirements
The EU gives also information on how and where to register
Standards to conform to
There are various standards that your device needs to comply to. they are not the same for every device. Easiest is to ask your NB to provide you with a regulatory pathway, or ask them to assess the one you create yourself.
If your device has a plug or a battery, you probably need to star with IEC 60601. IEC 60601 is the international standard for the safety and performance requirements for electrical medical devices.
There is a specific standard for usability: IEC 62366 (usability)
There is a specific standard for Software requirements: IEC 62304 (software life cycle)
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