To ensure that all medical devices sold via our platform are safe and don’t pose any health risks to our customers, it’s important to comply with all legal requirements and regulations. This applies to all consumer target groups. Please note that you’re always responsible for ensuring that your offer takes these conditions into account.
What are medical devices & risk classifications?
A medical device is an item with a medical purpose. Read more about medical devices here. Make sure you know whether your item counts as a medical device. Please note that these sales rights still apply to sales in Belgium.
Each medical device comes with a risk classification, an estimate of the risk that assesses the potential risk for the customer. Every medical device must have a risk classification. Risk classifications have consequences for the item and the obligations for the seller. Based on the classification, various conditions arise that the item must meet, such as having the item checked by a notified body for a medium or high-risk class. Annex VIII of MDR 2017/745 contains the classification rules for the risk class.
Legislation for medical devices
For medical devices, we’re currently transitioning from the Medical Device Directive (MDD) to the Medical Device Regulation (MDR). This means that there’s a transition period during which new medical devices must comply with the new laws and regulations, while the current range must continue to comply with Directive 90/385/EEC and/or Directive 93/42/EEC. If there’s a clear adjustment to the design and/or purpose of the medical device, it must immediately comply with the MDR.
The transition phase has been set to end on 31 December 2028. Up until this date you can still offer and sell the following medical devices:
- Class IIb devices that aren’t implantable
- Class IIa devices
- Class I devices that are bacteria-free or have a measuring function
Per 1 January 2029, the sale of the above-mentioned medical devices that fall under the old legislation is no longer permitted via our platform.
So, it’s important that you’re aware what the risk class of your items is. You can find this in the MDR under Annex VIII. If your items already comply with the new legislation of the MDR, you can sell your items without issue. It’s your responsibility to ensure that you’ll have a new valid declaration of conformity by the time you need it.
Product safety
Bol may ask for proof that your items comply with the law, such as technical documents that demonstrate that you comply with the conditions of the MDR. Make sure that these documents are readily available, together with your declaration of conformity. If we seriously suspect that your range is dangerous for the customer, we may take it offline (temporarily) while we’re assessing the (possibly) dangerous items.