Since MDR came into force, a lot has changed in the European context: in fact, MDR has sought to involve functions and regulate areas that were poorly or not-at-all regulated under the previous directive (MDD 93/42/EEC as amended).
In the field of Medical Device advertising, a constant reference element is the intended use: due to MDR, it is of crucial importance to state the intended use in an accurate, detailed, correct and identical manner in all parts of the Technical Documentation and related advertising communication. For example, if the intended use appears within the Technical Documentation, in the instruction for use, in the surgical technique, then it must also be stated using the same wording in the advertising material in order to avoid problems.
The topic of advertising is addressed in several parts within MDR (UE) 2017/745: as an example, it is mentioned in Article 5 of the MDR, which replaced the directive and which is the legislative measure through which, if compliant, Medical Devices can be placed on the market.
This article states that “a device may only be placed on the market if it complies with this Regulation”: it is therefore not possible, and constitutes misleading advertising, to promote a device that does not comply with the Regulation.
Not complying with the Regulation may be also due to the addition of properties that have not been validated under regulatory terms, for example during the clinical evaluation, the risk management or usability process or due to a lack of supporting documentation.
For the first time, Article 7 of the MDR in a legislative measure applied to Medical Devices on the regulatory level, regulates certain aspects related to advertising activities: the concept of “labelling” (which is typically American) has also been adopted by and used in relation to the European context, and with regard to relations with the FDA it indicates all information delivered outside the organization (to the patient, the professional, etc., also at the promotional level). Labelling includes not only the instructions for use accompanying the device and the characteristics of the device, but also advertising information.
Article 7 therefore stipulates that in labelling, in the instructions for use, when making a device available and putting it into use, and lastly in the advertising it is prohibited to use text, names, trademarks, pictures and figurative or other signs that could mislead the user or patient with regards to the device’s intended use, safety and performance.
This relates to the above-mentioned concept of misleading advertising, which can be created by:
- attributing to the device functions and properties that it lacks;
- creating false impressions regarding treatment or diagnosis, functions or properties that the device lacks;
- failing to inform the user or patient of a potential risk associated with the use of the device in accordance with its intended purpose;
- suggesting different uses of the device other than those declared to be part of the intended purpose for which the conformity assessment was carried out.
In Article 7(d) of MDR, there is therefore a ban on off-label advertising (and use) of the product, outside the label and the intended use as indicated on the label. The reference point is the Technical Documentation and System documentation which lead to product conformity.
Article 7 is mentioned in other parts, such as in Art.2.1 All. XV MDR (UE) 2017/745 dedicated to clinical investigations which are carried out according to an appropriate investigation plan corresponding to the state of scientific and technical knowledge and defined in such way as to confirm or reject the Manufacturer’s statements (the “claims” mentioned in Art.7 MDR) concerning the safety, performance and all aspects related to the benefits/risks of the device.
Due to MDR, it is not permitted to place on the market, other than devices that comply with the regulation, but it is permitted (as with MDD) to advertise, particularly at trade fairs, exhibitions and demonstrations, devices that are not yet marked. However, there must be a visible indication on the device that it is not certified, but it is instead a prototype used for exhibition purposes only.
In conclusion, it is necessary for those involved in communication and marketing to faithfully and truthfully state the regulatory-approved information in the advertising material before it is issued.
>>> How can we help you advertise your Medical Device in compliance with MDR requirements?
Through our strategic-regulatory consulting services, Thema’s experts can guide you in complying with the requirements of the MDR Medical Device Regulation (EU) 2017/745 regarding communication and advertising.
Contact us for more information!
