[Updated on 8 July 2021] Further to the entry into force of EU Medical Devices Regulation 2017/745 on May 26 2021, the Romanian Government issued an Emergency Ordinance setting forth the institutional framework for ensuring the MDR’s direct application (“GEO no. 46/2021”) and announced that the Ministry of Health will issue the secondary legislation in the following months.
Pharmaceutical and medical devices companies should be aware that the Romanian authorities intend to implement strict rules for the promotion of medical devices, similar to the ones already applicable to the promotion of medicines for human use.
According to GEO no. 46/2021, the advertising and promotion of medical devices in Romania includes any activity designed to stimulate the use, distribution, sale, or supply of medical devices, such as visits of medical representatives to prescribers, the provision of samples, the sponsorship of promotional events and scientific congresses, and other activities involving the supply of information to healthcare professionals and/or the public.
Promotion of Medical Devices to the Public
Medical devices companies will be able to promote or advertise to the public only those medical devices which can be used without medical intervention.
Advertising materials designed for the public will have to be approved in advance by the National Agency of Medicines and Medical Devices (NAMMD), based on the request of the device’s manufacturer, importer, or local distributor. By law, the NAMMD should assess the advertising materials within 30 days of the request. However, in light of the current state of alert in Romania and the significant workload of the regulatory authorities, certain medical-device companies present on the local market have expressed concern that this new requirement could delay the launch and implementation of promotional campaigns.
GEO no. 46/2021 states that the advertising materials should not be misleading, should present accurate, verifiable, updated, and complete information for the target audience consistent with the user manual, and that claims regarding the product’s intended use and its benefits should be backed up by relevant scientific proof.
Certain prohibitions will impact current market practices. For example, the advertising of medical devices by scientists, healthcare professionals, and/or influencers or other famous people will no longer be permitted. Also, TV spots and advertising materials should observe the new requirements by removing any misleading or inadequate visual representation.
Promotion of Medical Devices to the Healthcare Professionals
Advertising materials intended for healthcare professionals should contain specific information concerning the medical device and should comply with certain new requirements to be further detailed in the secondary legislation. Such materials should expressly indicate that they are designed exclusively for healthcare professionals and provide a minimum level of information regarding the medical device’s name, indications, class, and details regarding proper use.
The NAMMD is empowered to perform compliance checks on material designed for healthcare professionals, even if the company producing that device or material was not required to obtain the NAMMD’s authorization before using the material on the Romanian market.
The NAMMD may apply various fines and sanctions for the failure to comply with the new law, including having the medical device withdrawn from the market, being prohibited from using the medical device or placing it on the market, and having the authorizations held by the medical-device importers and distributors withdrawn or suspended.
The Ministry of Health should elaborate the secondary legislation on the promotion of medical devices within 60 (sixty) days as of the entry into force of GEO no. 46/2021.
By Dan Minoiu, Partner, Musat & Asociatii