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 Articles 6 of the MDR/IVDR serve as guidelines for online sales of medical devices. While online or distance selling may facilitate product availability, it does not necessarily constitute the initial placing on the market.
Several aspects must be considered:
- Distance Sale of Already Marketed Products: Online sales may refer to products already placed on the EU market by the manufacturer or importer before their online offering.
- Fulfilment Service Providers: Products offered online often pass through fulfilment service providers in the EU for efficient delivery. Once released for free circulation, these products are considered placed on the market, with the fulfilment service provider assuming the role of the importer.
- Direct Purchase by EU End-Users: Products bought directly by EU end-users from outside the EU through online or distance sales are considered placed on the market when the order is placed and confirmed. Importer obligations apply in such cases.
- Devices Used in Commercial Activities: Devices used in a commercial activity, even if provided free of charge, for diagnostic or therapeutic purposes in the EU, must comply with the MDR/IVDR. Member States can intervene to protect public health.
Requirements for Selling Medical Devices in the EU:
Regardless of the sales channel, manufacturers must adhere to applicable laws, including the MDR/IVDR:
- Prepare comprehensive technical documentation.
- Establish a Quality Management System.
- Engage a Notified Body for device certification, if applicable.
- Appoint a professional Authorized Representative such as Obelis if the company is based outside the EU.
- Designate a Person Responsible for Regulatory Compliance (PRRC).
- Register devices with the Competent Authority/EUDAMED.
- Ensure compliance throughout the supply chain.
- Familiarize yourself with national regulations implemented by Member States.
With over 35 years of experience providing EAR services, Obelis offers comprehensive support and expertise to navigate the regulatory landscape and ensure compliance.
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.