When venturing into online sales of medical devices and in vitro diagnostics (IVDs) in Europe, compliance with the regulations becomes paramount. This article sheds light on the essential aspects to be considered when offering medical devices to European patients and users through online platforms. With a focus on distance selling, we explore the regulatory requirements and provide insights to help manufacturers ensure compliance while reaching a broader market.
Understanding Online Sales of Medical Devices
To grasp the regulatory landscape, it is vital to comprehend the concept of placing products on the market. Manufacturers must fully comply with the Medical Devices Regulation (MDR) or In Vitro Diagnostic Devices Regulation (IVDR) before introducing products into the EU. However, legacy devices benefit from a transition period, allowing compliance with previous directives and some requirements of the MDR/IVDR.
Regulation of Online Sales
The European Commission Blue Guide 2022 and Article 6 of the MDR/IVDR provide guidance on online sales.
Key points include:
- Distance Sale of Already Marketed Products: Online sales may involve products already placed on the EU market by the manufacturer or importer.
- Fulfilment Service Providers: Products often pass through EU-based fulfilment service providers. Once released for free circulation, these products are considered placed on the market, and the fulfilment provider assumes importer responsibilities.
- Direct Purchase by EU End-Users: Orders shipped directly from outside the EU are considered placed on the market when the order is confirmed. In these cases, importer obligations apply.
- Devices Used in Commercial Activities: Devices provided, even free of charge, for diagnostic or therapeutic purposes must comply with MDR/IVDR. Member States may intervene to protect public health.
Key Requirements for Selling Medical Devices Online
Regardless of the sales channel, manufacturers must:
- Prepare comprehensive technical documentation.
- Establish a Quality Management System (QMS).
- Engage a Notified Body for device certification, if applicable.
- Appoint a professional Authorized Representative (EAR) if based outside the EU, such as Obelis.
- Designate a Person Responsible for Regulatory Compliance (PRRC).
- Register devices with the Competent Authority/EUDAMED.
- Ensure supply chain compliance.
- Familiarize with national regulations implemented by EU Member States.
With over 35 years of experience, Obelis provides comprehensive EAR services, supporting manufacturers to navigate regulatory requirements and ensure compliance for online sales.
Compliance with the regulations is crucial when engaging in online sales of medical devices in Europe. Understanding the nuances of distance selling, adhering to regulatory requirements, and partnering with experienced service providers like Obelis can empower manufacturers to expand their reach while maintaining their credibility in the market.
FAQ
1. Do medical devices sold online in the EU require compliance with MDR/IVDR?
Yes. All medical devices and in vitro diagnostics (IVDs) sold online in Europe must comply with the Medical Devices Regulation (MDR) or In Vitro Diagnostic Regulation (IVDR) before being placed on the market.
2. What does “placing on the market” mean for online sales?
Products are considered placed on the EU market when they are first made available to EU users, whether through an EU-based importer, fulfilment provider, or direct sale from outside the EU.
3. Do I need an EU-based Authorized Representative for online sales?
Yes. If your company is outside the EU, you must appoint an Authorized Representative (EAR) to act as the regulatory point of contact with EU authorities.
4. What role do fulfilment service providers play in online sales?
If products pass through an EU-based fulfilment service provider, that provider assumes importer responsibilities once the products are released for free circulation in the EU.
5. Are there specific obligations for devices sold directly to EU end-users from outside the EU?
Yes. Such devices are considered placed on the market when the order is confirmed, and importer obligations apply.
6. What documentation is required for online sales compliance?
Manufacturers must maintain technical documentation, a Quality Management System (QMS), device registration, and PRRC designation, along with Notified Body certification if applicable.
7. Do national regulations affect online sales of medical devices?
Yes. While MDR/IVDR sets EU-wide standards, Member States may implement additional national regulations, especially regarding distance selling and public health protection.
8. How can manufacturers ensure compliance while selling online?
Partnering with an experienced regulatory service provider like Obelis helps ensure proper registration, technical documentation, supply chain compliance, and ongoing regulatory updates.
9. Are legacy devices exempt from full MDR/IVDR compliance?
Some legacy devices may benefit from transition periods, allowing partial compliance under previous directives, but full compliance is eventually required to continue marketing in the EU.