what you need to know
Nowadays, online shops are a common source for buying all sorts of products and services. Thus, it’s a logical consequence that medical devices are being sold online as well. Read here what you need to know when operating an online shop offering medical devices.
What is understood as distance sales?
Distance sales, or an online shop, as we know it, is a virtual place at which products and services can be acquired and order to be delivered to an address defined by the client. The Medical Device Regulation MDR 2017/745 defines it a bit different in Article 6 as “A device offered by means of information society services to a natural or legal person established in the Union”. So, the regulation refers to distance sales, the sale process actually taking place in a virtual environment, such as the internet, and the medical device is than physically sent to the client residing in the EU (or states in the European Economic Area (EEA) or bound to the regulation by a Mutual Recognition Agreement (MRA). So, online shops are actually qualifying themselves under the MDR as distance sales if medical devices are offered and sold.
What are the minimal requirements under the MDR 2017/745?
To be exposed to the MDR 2017/745 as an online shop, the following must be taken care of:
- Medical Devices are offered over the internet or any other media for which buyer and seller are not physically present
- Medical Devices are offered to natural or legal person in the EU
- The seller is offering/selling/or making available the medical device and does not only offer a platform for sellers and buyers to match
- The seller must provide an EU Declaration of Conformity (DoC) of all offered products upon request by the competent authority
In the case that a seller of medical devices is subject to the MDR 2017/745 compliance but does not comply, the competent authority can enforce to cease the service of distance sales.
Who needs to get certified according ISO 13485?
These requirements lead to the question who needs to be certified according to ISO 13485? The regulation calls out only to manufacturers of medical devices. These manufacturers are understood to be the legal entity making a medical device available to the market under its name. This “making available” includes the overview and management of all requirements as stated in ISO 13485 and the MDR for the product.
My affiliate has an online shop with my medical devices
If not placed on the market (by means of distance sales) by yourself, you might use an affiliate or a distributor to do so. In the MDR 2017/745, Article 2, the distributor is defined as “distributor means any natural or legal person in the supply chain, other than the manufacturer or the importer, that makes a device available on the market, up until the point of putting into service”. Thus, it is not excluded that the distributor uses an online shop to do so, however it must be clear that the distributor is the seller of the medical device. The same would apply if the affiliate selling the medical device over online shops or alike, qualifying for distance sales.
In the case that the online platform only offers a match-making between seller and buyer, the platform does not qualify as distance sales and thus, does not become an economic operator.
Is an online shop a distributor under MDR 2017/745?
This is a very good question, and the short answer is yes. Regarding the definition of “distributor” in the MDR 2017/745, Article 2, an online shop would qualify as a distributor, and in consequence as economic operator. Thus, the owner of the online shop must accept the duties and responsibilities under the MDR 2017/745, Article 14 and if applicable Article 22.
Duties and responsibilities for online shops
The MDR, Article 14 defines the obligations of distributors. These are given here:
- Act with due care under the MDR
- Verify before making available on the market that:
- Medical Device is CE-marked
- DoC is available for the medical device
- Information is supplied with the medical device as per MDR, Article 10(11)
- If medical device is imported, that the importer complies with the requirements in MDR, Article 13(3)
- If the medical device is deemed not in conformity with the MDR 2017/745, make the medical device not available to the market and inform the manufacturer
- If deemed that the medical device presents a serious risk or is falsified, in addition to informing the manufacturer, the competent authority has to be informed too
- Comply with transport and storage conditions as long as under the responsibility of the distributor
- Support economic operators in Corrective Actions and Preventive Actions (CAPA)
- Keep a register of complaints, non-conforming devices, recalls and withdrawals
- Need to be able to show to the competent authority by documentation that the medical device is in conformance with MDR 2017/745