June 2021 – On 11 June 2021, the Government Emergency Ordinance no. 46/2021 (“GEO no. 46/2021”), which establishes the institutional framework and measures for the implementation of Regulation (EU) 2017/745, entered into force. The aim of GEO no. 46/2021 is to ensure the proper functioning of the placing and making available on the market of medical devices for human use and the accessories for such devices.
Below is a summary of the key changes introduced by GEO no. 46/2021:
Advertising of medical devices
One of the most active areas of legislative reforms remains the advertising of medical devices. GEO no. 46/2021 introduces provisions on this topic, distinguishing between advertising to HCPs and to the general public. The advertising regime for medical devices presents elements of similarity with the advertising of medicinal products – e.g. distinct rules for HCPs/general public; NAMMD permit for advertising to the general public.
For HCPs, advertising of medical devices may be performed via visits by medical representatives; the provision of samples; sponsorship of promotional meetings, with persons qualified to recommend or distribute medical devices as participants; sponsorship of scientific conferences; and, in particular, the payment of transportation and accommodation expenses.
Advertising to HCPs of a medical device with a high degree of risk to public health must be notified in advance to NAMMD.
For the general public, GEO no. 46/2021 provides that:
In case of non-compliance, fines ranging from RON 10,000 (approx. EUR 2,050) to RON 20,000 (approx. EUR 4,100) and the advertising cessation can be triggered.
There are still various points opened for discussion, particularly concerning the advertising of medical devices. These are expected to be clarified via the norms of implementation to be enacted in the coming months, which will probably pencil also the approach of NAMMD towards the new rules.