Follow these 4 steps for selling medical devices

The new legislation applies to the selling via bol of all medical devices in the European Union. These include items that can serve as medical devices and any accessories. All legal requirements for medical devices are included in the MDR 2017/745. This is quite a comprehensive document, which is why we are introducing our new policy. In it, you will find more explanation about the legislation and obligations.

1. Check which of your items are considered medical devices. On this CCMO page you will find an explanation for this.
2. Then, check pages 10 to 12 in this download from the Dutch government to see if the risk classification of these medical devices is still current. Please note: some items have received a higher risk classification.
3. Collect the correct documentation per item by requesting it from the manufacturer or supplier – see the list below. This includes the declaration of conformity, photos of the item packaging, a technical report, and a complete manual that meets the requirements of the new legislation. On the website of Ondernemersplein you will find more information.
4. Add the required information to the characteristics of your items – see the list below.

To comply with the law and demonstrate this to the customer, you need to supplement your content on bol.com between March 3 and July 1, 2022, with the following information.

In the 'Type of health item' field, select 'Medical device' and fill in:

• which legislation the item falls under
• what the risk classification of the item is
• the name and address of the manufacturer
• whether a CE marking is present (yes or no)

  
  For new product ranges, we also expect a photo of the CE marking visible on the packaging.

• the storage instructions
• the safety warnings
• UDI-PIs (Unique Device Identification for device production unit identification). *This is only mandatory for devices that are also supplied to healthcare institutions. More information about the exception of a UDI-PI is to be found in MDR – Annex VI, Part C, Section 4.4

On March 3, 2022, the new policy takes effect, and from that moment on, you can fill in the above information for your items' content on bol.com. You have until July 1, 2022, to do this.

From July 1, 2022, we will actively check whether the above-mentioned characteristics have been filled in for all relevant items. Additionally, we may contact you for supplementary documentation, such as the declaration of conformity. Make sure you have this readily available!

Our advice is to arrange this as soon as possible. Collecting all the necessary data and documents can take several weeks, and the sooner we comply with the legislation together, the better.

In May 2022, the IVDR will also come into effect for self-tests. More information on this will follow. The exact deadline for adding every class of medical device to EUDAMED is still uncertain. Currently, EUDAMED is not yet fully functional. The deadline is 24 months after EUDAMED becomes fully functional.