In recent years, we have seen a dynamic increase in online sales of medical devices. The electronic distribution channel for medical devices remained out of the control of regulators until February 20, 2016. The gullity of customers – especially the elderly, unreliable advertising, and finally the sale of devices that often did not meet the essential requirements and could pose a threat to potential users – caught the attention of the Legislature, which introduced regulations aimed at increasing patient safety. Currently, the sale of medical devices online is subject to the supervision of the President of the Office of Registration of Medicinal Products, Medical Devices and Biocidal Products.
The Medical Devices Act defines the mail order sale of devices as: 'a contract for the sale of a device concluded with a consumer under an organised distance contracting system, without the simultaneous physical presence of the parties, using only one or more means of distance communication up to and including the time of conclusion of the contract'.
In order to regard online sales of a product as distance mail order within the meaning of the above definition, the following conditions must be met:
- the absence of a simultaneous physical presence of the parties – one of which must be a trader and the other a consumer – related to the form of contracting resulting from the use of distance communication techniques (Internet) up to and including the conclusion of the contract;
- the conclusion of the contract should take place within the framework of a distance contracting system organised by the trader, which includes situations where the trader has included the possibility of concluding a contract by means of distance communication within a certain organisational framework, i.e. the conclusion of such an agreement cannot be exceptional or incidental from the trader's perspective.
Since February 20, 2016, the supervision of the President of the Office of Registration of Medicinal Products, Medical Devices and Biocidal Products is also subject to mail order sales of medical devices. This means that traders providing means of distance communication are obliged, at the request of the President of the Office, to make available to him without delay data relating to products and entities selling products by mail order, such as:
- the name and address of the operator and, if available, his telephone number, fax number and e-mail address;
- the name and address of the manufacturer of the device;
- the trade name and generic name of the product.
The law provides for a fine for breach of the obligation to make the data available to mail order operators of medical devices.
KONDRAT Law Firm and Partners
biuro@kondrat.pl
photo source: www.freeimages.com