Distance sales devices are medical products sold remotely, often through online platforms or digital channels. These devices are subject to specific regulations outlined in Article 6 of the Medical Device Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR). Article 6 to ensure safety of distance sales medical devices.
Article 6 to ensure safety of distant sales devices
Article 6 of the MDR and IVDR ensures that devices sold remotely meet the same safety and performance standards as those sold through traditional channels. It covers both devices sold directly to consumers and those used by healthcare professionals to deliver remote services. In this sense, even if a medical device or IVD is not sold directly to consumers by placing it on the market, it still needs to comply with the MDR or IVDR if it is used in a commercial setting to provide healthcare services. This includes also medical devices and IVDs which are not directly placed on the EU market, but process data or samples collected from patients in the EU.
Declaration of Conformity: a crucial document for all medical devices
An important aspect of Article 6 is the requirement for an EU Declaration of Conformity, sometimes referred to as “DoC”. This document, essential for all manufacturers affixing the CE marking, certifies that the device meets the necessary safety and performance standards. Also for distance sales devices, competent authorities can request the Declaration of Conformity to verify compliance.
European Authorised Representative for distance sales devices
Since distant sales devices must be fully compliant with the MDR or IVDR, non-EU manufacturer should appoint European Authorised Representative (EAR), just like any other manufacturer based outside of the EU as described in Article 11. The EAR is appointed through a written mandate and is a legal entity established in the EU that acts as a representative for the manufacturer. Among other tasks, the EAR:
- Verifies that the technical documentation and other essential documents have been drawn-up, and that the manufacturer has complied with their registration obligations.
- Provides the competent authority with all the information and documentation necessary to demonstrate the conformity of a device.
- Forwards to the manufacturer any request by competent authorities.
- Cooperates with the competent authorities on any preventive or corrective action taken to eliminate or mitigate the risks posed by devices.
- Immediately informs the manufacturer about complaints and reports from healthcare professionals, patients and users about suspected incidents related to a device included to the mandate.
Do you have questions on compliance of medical devices and IVDs in Europe?
References:
Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices; Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices. Retrieved on 29/10/2024.
Afonso Alvoeiro
Regulatory Affairs Department
29.10. 2024
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