Complying with the rules on distance selling of medical devices and in vitro diagnostics device is a fundamental step when a manufacturer chooses to sell the devices online. In this article we present the aspects to be considered when a medical device is offered to EU patients and users online.
Online sales: placing on the market
The placing on the market is key in defining the regulatory requirements that apply to a product. From May 2021 for medical devices and from May 2022 for IVDs, manufacturers shall fully comply with MDR/IVDR before offering a product in the EU. Only manufacturers of legacy devices can benefit from a longer transition period and comply with the previous Directives and some requirements of MDR/IVDR.
How are online sales of medical devices regulated?
The online sales of medical devices are addressed in Article 6 of MDR & IVDR and section 2.4 of the European Commission Blue Guide 2022. In particular, the Blue Guide specifies that online or distance selling may be a manner of making products available. Nevertheless, it does not necessarily constitute the first making available of the product on the Union market (i.e. the placing on the market). The actual placing on the market of these products may differ for each individual product, depending on the specific distribution chain. The following aspects should be considered:
- The distance sale or online offer may refer to products that have already been placed on the Union market. This is the case where the EU manufacturer or an importer has already placed them on the Union market before they were offered for sale online or through other means of distance selling.
- Some products offered online or through other means of distance selling to end users in the Union are transferred first to fulfilment service providers. These providers are located in the EU to guarantee their swift delivery to EU end users. Accordingly, products stored by such fulfilment service providers and released for free circulation are considered to have been supplied for distribution, consumption or use on the EU market and thus placed on the EU market. When an online operator uses a fulfilment service provider in this manner, by shipping the products to the fulfilment house in the EU, the products are in the distribution phase of the supply chain. These products are considered placed on the market at the time they are released for free circulation. In addition, the fulfilment service provider is considered as the importer where there is no manufacturer, importer or AR designated.
- Some products outside the EU can be bought directly by end-users in the EU online or through other means of distance sales. These products are deemed to be made available in the Union prior to any transaction for the purposes of checks by market surveillance authorities pursuant to Regulation (EU) 2019/1020. They are placed on the market at the moment an order by an end user has been placed and confirmed for a specific product. The product has to be already manufactured and ready to be shipped. An importer is defined as being any natural or legal person established in the EU that places a device from a third country on the EU market and MDR/IVDR Article 13 describes many of the general obligations of importers.
- There are also cases where the device is not placed on the market, but manufacturers need to nevertheless ensure MDR/IVDR compliance. This applies to devices that are ‘’used in the context of a commercial activity, whether in return for payment or free of charge, for the provision of a diagnostic or therapeutic service offered to a natural or legal person established in the Union.’’ (Art. 6(2) MDR & IVDR). Moreover, Members States can request the information society service to stop its activity on grounds of protection of public health (Art. (4) MDR & IVDR).
Section 3.7 of the Blue Guide, on the other hand, addresses the intermediaries, in particular the intermediary service providers under the E-Commerce Directive. The E-Commerce Directive establishes the legal framework for electronic commerce in the EU. It introduces harmonised rules on issues such as the transparency and information requirements for online services providers, commercial communications, or electronic contracts.
Requirements to sell medical devices in the EU
Whether medical devices are sold in a physical store or through internet, manufacturers shall respect applicable law (MDR/IVDR – special regime for legacy devices):
- Prepare a complaint technical documentation
- Set up a Quality Management System
- Find a Notified Body that can certify your devices (designation scope!) – if applicable
- Mandate a professional Authorised Representative, if your company is based outside of EU
- Appoint a PRRC – Person Responsible for Regulatory Compliance
- Register the device to the Competent Authority/EUDAMED
- Make sure that your supply chain complies with Regulation requirements
In addition, Member States have adopted regulations at their national level to govern the distance selling of medical devices. The MDlaw RA Map presents the various Member States and their steps adopted to implement the MDR and IVDR.
Finally, the Blue Guide states that the CE marking and any required warnings should be visible to the end user and indicated on the website before the purchase.
Are you based outside of the EU and wishing to sell your devices online to the European territory? Mandating a European Authorised Representative is mandatory. Contact Obelis with almost 35 years of experience providing EAR services.
Regulatory Affairs Department
European Union (2017). Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC. Retrieved on 28/02/2023.
European Union. (2022). Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC. Retrieved on 28/02/2023.
European Commission. (2022). The ‘Blue Guide’ on the implementation of EU product rules 2022. Retrieved on 28/02/2023.
European Union. (2017). Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU. Retrieved on 28/02/2023.
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