CEE region – full freedom due to absence of regulation?
Is the medical device sector free to use the advantages of online sales in the CEE region? Or do medical devices (MD) have to be sold in specialist shops? Are online sales restricted to special types of device? Or can the whole range of products, no matter how sophisticated, be offered via the Internet? These are only some of the questions that arise for manufacturers of medical devices intending to sell their consumer products in the CEE region. In most Central and Eastern European countries where bnt attorneys in CEE are represented, no special regulation exists for online sale of MDs. In Poland, online sale of MDs is generally allowed no matter whether by Polish or foreign companies located within the EU. Likewise, virtually no special rules apply to online sales of MDs in the Czech Republic, Bulgaria, Belarus and the Baltic States. In Hungary, sale of MDs forming a medical aid is limited to pharmacies only.
Perhaps the strictest rules in this respect are in place in Slovakia. Online sale of MDs is defined as sale of MDs based on an electronically filed order processed through the website of a public pharmacy or a pharmacy issuing medical devices. This can be done solely by these types of enterprises within Slovakia or from abroad only by a holder of a licence to provide the services of a public pharmacy or a pharmacy issuing MDs. A prohibition of online sale applies to active implantable MDs, in vitro diagnostic MDs, class III MDs, as well as certain class IIa and IIb devices. But we should note that different rules apply as soon as MDs are to be reimbursed by national social security systems.
In Poland, the sale of prescription MDs eligible for reimbursement by national health insurance is possible only if actual delivery occurs in a pharmacy or specialized medical shop located in Poland. Otherwise the patient pays in full, with no reimbursement. Thus, online sales of prescription medicinal products (drugs or e.g. MDs including drugs) are prohibited. In the Baltic States, Belarus, Hungary, Bulgaria, Slovakia, and Czech Republic, too, reimbursed MDs have to be sold either in pharmacies or in certain other specialised shops.
And what does the new Medical Devices Regulation (MDR) add to the topic? The answer is: hardly anything. As complex as it appears, it regulates all aspects of MDs, including duties of their distributors, without however distinguishing between those sold online and those sold in regular shops or pharmacies. The words “online” or “Internet” do not even appear in the MDR text.
Online sale of MDs remains an area that is not directly regulated by EU legislation. Any potential restrictions actually targeting sale of MDs via electronic communication can only be found in local laws.
With certain exceptions and except for reimbursed MDs, online sale is allowed in Poland, the Baltic States, Belarus, Hungary, Bulgaria, and the Czech Republic without limitations, whereas the Slovak Republic applies a stricter regime.