+390677209020 | +39 0267380552 info@direnzo.biz | sedemilano@direnzo.biz


Distance sales of medical devices

During the pandemic, which forced shops to be opened with limitations and people to stay at home more than before, a real boom in online sales has been observed. Distance sales involve medical devices, which can be purchased both by means of platforms including products of several commodities sectors and by directly contacting manufacturers and distributors through their websites, if any.

Since the beginning of the pandemic the availability in the e-commerce of specific medical devices, such as surgical masks or pulse oximeters, substantially increased due to the importance of these medical devices in fighting the disease. However, online sales do not always meet all the requirements according to the legislation specific to the MDs.

The Directive 93/42/EEC does not establish requirements specific to the e-commerce of medical devices. It must be reminded that this law was approved in the early 90s and its last change went back up to 2007, when online sales were present but they were not as widespread as nowadays.

Guidelines concerning health advertising of MDs were published on the website of the Italian Ministry of Health; these documents defines the possibility of including advertisements on websites. An advertisement could undergo authorization from the Ministry of Health depending on the kind of information present in the advertisement itself.

The Regulation (EU) 2017/745, which will enter in force repealing the directive on the 26th of May, 2021, after a delay due to the pandemic, gives some information about online sales. The Regulation establishes that an economic operator shall offer a MD by means of distance sales only if the MD meets the requirements of the Regulation itself. The Regulation thus makes the conformity of the MD explicit for an economic operator, stressing the need for the CE marking, in order to sell the MD online. The directive did not make this aspect explicit, although the obligation of conformity was clearly established for all the MDs placed on the market or put into service in the EU territory.

The Regulation also defines some features concerning the accompanying documents to be put at user’s disposal for the online sales. In the section related to the requirements to be met according to Annex I for the provided information, the law establishes that the manufacturer must make available all the information for identification of MD and manufacturer, for safety and for performance in the last updated form on manufacturer’s website, if any. This requirement does not apply to digital platform offering products on behalf of the manufacturer.

The sale of MDs is not only subjected to special laws, but it is also subjected to laws which apply to all product classes, such as the Italian “Codice del Consumo” (i.e. Consumer Code). This law provides directions regarding distance sales which are applicable to all products; these directions also include that the necessary information (as an example, information related to principal features of goods and services) must be provided in a way appropriate to the used communication means in a simple and comprehensible language style for distance sales. As a consequence this information shall be written in Italian language.

Written by: Daniele Scarpino

Foto di Pete Linforth da Pixabay