Contrary to the regulatory tradition regarding the medical device advertising, and surprisingly given the lack of similar regulations in European legislation, in the summer of 2021 the Romanian legislator opted for the establishment of an obligation to approve all advertising materials intended for the general public and that concern products included in the medical devices category, which range from toothpaste and condoms to wheelchairs and pulse-oximeters.
The legislative project that is covered by our informative pierce creates a potentialy significant impact on the activity of all companies that carry out activities related to medical devices in Romania – from those specialized in this field to retail operators that sell a limited category of medical devices. All of these companies will be forced to reconsider their entire strategy for promoting the medical devices that they have in their portfolio, and to do so quickly.
Following the publication of the emergency ordinance that established the institutional framework and measures for the implementation of Regulation 2017/745 on medical devices, the position expressed by the national regulatory authority (National Agency of Medicines and Medical Devices in Romania, in Romanian short: ANMDMR) was in the sense that until the publication of the rules of application of the Emergency Ordinance no. 46/2021 on establishing the institutional framework and measures for the implementation of Regulation (EU) 2017/745, the provisions relating to advertising do not apply.
In September 2022, more than 15 months after the entry into force of GEO no. 46/2021, the Ministry of Health publishes in transparency the draft Order for the approval of the Methodological Norms regarding advertising of medical devices (“the draft Order”).
- Recipients of the provisions of the Draft Order
- Scope of the Draft Order
- The newly established obligations for economic operators
- Prohibitions and restrictions
- The obligation to notify the organization of medical events
- Entry into force and potential transitory issues
In summary, in the Prohibitions and Restrictions sections, the draft Order provides the following:
- Actions that are forbidden include:
- advertising intended for the general public presented through social media or mobile applications
- advertising to the general public containing promotional offers or references to discounts, price reductions, special prices
- comparative advertising for the general public. Comparative advertising aimed at healthcare professionals is permitted only under the restrictively regulated conditions
- Advertising for medical devices in the audiovisual field is allowed only in the case of medical devices that are not intended for use by health professionals.
- Samples will be offered only exceptionally, only to persons qualified to prescribe or distribute such products, in compliance with the conditions imposed by the regulations in force.
- Sponsorship of any kind aimed at the general public cannot be linked to the name of a medical device.
Our full overview on the topic is available (in Romanian only) HERE.
For specific details on the matters of interests concerning medical devices and the promotion activities regarding them, please contact Ana-Maria Baciu or Ana-Maria Corugă.