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:
- The information provided by the manufacturer together with the medical device must be in the Romanian language, without excluding the presentation of such information in other official languages of the European Union. Instructions of use for healthcare professionals (“HCPs”) can also be provided in English, subject to the written consent of the HCPs.
- A new system facilitating the traceability and transparency of medical devices—the unique device identification system (“UDI”)—has been introduced. Public and private health institutions in Romania are obliged to store and keep, in electronic format, UDIs of all implantable medical devices provided by or to these institutions.
- Public and private health institutions must report serious incidents to the competent Romanian authority (“NAMMD”) involving the use of a medical device manufactured within such institutions, for their own use, and the corrective measures taken.
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:
- only advertising for medical devices that can be used without the intervention of HCPs (with the exception of pharmacists) is allowed;
- the mandatory minimum information for advertising materials is regulated (e.g., a clear definition of the purpose of the medical device);
- there are several restrictions on the content of advertising materials (e.g., such cannot suggest that the health of individuals may be affected if the medical device is not used);
- the manufacturer, importer or distributor must obtain a permit from NAMMD prior to advertising a medical device to the general public.
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.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.