Advertising of medical devices, what changes with the new European regulation


As is known, health advertising for medical devices must respond to a series of additional requirements with respect to that relating to other types of market. Although limiting for corporate marketing, these constraints respond to the need for special safeguards typical of healthcare products.

Recent, important changes have been made in the medical device sector, with the introduction of the new European Regulation (EU) 745/2017, fully applicable from May 26, 2021.

The relevant aspects for the business world are the central topic of the interview granted to me by Silvia Stefanelli, lawyer owner of the Stefanelli & Stefanelli law firm, specializing in issues relating to health law.

What are the novelties of the new Advertising Regulation?

The main new element concerns the very introduction of a community regulation on advertising. We must in fact remember that on this specific aspect Directive 93/42 / EEC (MDD) did not contain any regulations: in the implementation phase of the same, the Italian legislator then introduced art. 21 of Legislative Decree 46/97, which establishes a legal architecture of an authorization nature similar to that of the drug.

In Regulation (EU) 745/2017, advertising is expressly regulated in an article (Article 7) called “declarations”, a title that expresses the fact that the reference areas are not limited to advertising, but extend to all that is declared regarding medical devices.

Therefore, if before we could have thought that in the absence of EU legislation there could be a space for the national legislator to issue its own legislation on advertising, today the legal instrument has changed and this, in my opinion, requires a change in the scenario.

Firstly, we are no longer dealing with a directive, but with a regulation: as such, legislation directly applicable in the same way in all Member States that does not require any element of national implementation.

This legislative choice today provides a discipline at Community level which can be considered exhaustive and which, in my opinion, leaves no room for national disciplines.

Secondly, the EU legislator has expressed its opinion on how it believes that the advertising of medical devices should be regulated: this should make us reflect on the possibility of keeping art. 21 of Legislative Decree 46/97.

How could article 7 of the MDR impact the communication and marketing strategies of companies in the long term?

A legal question arises on this point. The question that everyone is asking is whether the setting of art. 21, with the authorization regime and the apparatus of ministerial guidelines, must be completely maintained, both in the procedural aspects (those related to the authorization) and in the content (i.e. the contents of the guidelines and the criteria with which the authorization is issued, borrowed from the world of drugs) or whether we should embrace the legal thesis that art. 7 has canceled the legislative provisions in place at national level.

In the first case, the provisions of art. 7 MDRs would be added as such to the national discipline: this is the position taken by the Ministry of Health in the Circular of 12 November 2021.

In the second, which I personally believe to be more legally founded, the provisions of art. 7 MDRs would be the only ones to follow.

In this regard, I believe a clarification is appropriate: art. 7 is very punctual and reminds all the parties involved (not only the manufacturer, but also the distributors and those who simply present the product verbally) to the utmost consistency between the declarations relating to the medical device and the scientific evidence related to it.

This means that, even embracing the thesis that art. 7 has done away with all the authorization apparatus, the criteria are still very stringent.

Boasting, in the communication activity, characteristics not supported by adequate scientific foundations referred to in the technical file of the product, the sanctioning consequences that will be established in the decree under development (pursuant to art.15 l.n. 53/2021) or the sanctions of the more general discipline of misleading advertising.

Moreover, reading the provisions of art. 7 clearly shows the fact that it is a specification of the general regulation on misleading advertising contained in the Consumer Code for patients and in the Legislative Decree 145/2007 for B2B advertising.

The MDR seemed to have also eliminated the need for ministerial authorization but a circular from the ministry reaffirmed that the authorization regime of Legislative Decree 46/97 is compatible with the new regulatory framework. What is your opinion about it?

Personally, I do not agree with the legal position taken by the Ministry of Health, because I believe that the compatibility assessment must be carried out on the basis of specific legal principles expressed by the community judgments.

In my opinion, an authorization regime such as the one referred to in art. 21 of Decree 46/97 and the ministerial guidelines cannot be considered compatible with European legislation because it is very restrictive also from the point of view of the free circulation of goods and services.

We must not forget that advertising is a former business activity. art. 41 of the Constitution, pertains to the area of ​​free circulation of community services and is an element of absolute importance in the field of competition.

From this point of view, I consider the national regime to be very restrictive and I believe that this restriction is not “justified” (according to EU principles) from the point of view of the protection of public health. In general, in fact, Member States are not prohibited from introducing limitations to European legislation, but here we are in the presence of a structured and harmonized regulation.

In this context it is not absolutely forbidden to introduce limitations at national level but it would be necessary to specify the objectives, the rationale, the legal position that these additional constraints allow to protect. Moreover, unlike other countries, we have an identical authorization regime for the advertising of medical devices, regardless of the class they belong to and the risk they can cause to patients’ health.

Therefore, an option could be to limit the additional constraints only to higher-class devices, those related to greater risk. In this case, the will of the Italian legislator to respond to the need for collective protection would be clear.

Moreover, the November 2021 circular to which you referred is very sparse and does not provide justifications in support of the compatibility between EU and national legislation.

Do you believe that the provision intends to prevent the risk of discretion in the interpretation of the rule?

I think not. Analyzing the rules on misleading advertising, now contained in the “Consumer Code”, the analogy with art. 7, also from the terminological point of view.

Today, all advertising schemes are, within the EU, free and subject to subsequent control, according to a discipline that also provides for very heavy penalties for companies.

The fundamental legal choice is between two alternatives: the imposition of a preventive regime (authorization) or the use of a subsequent legislative control instrument.

Personally, I believe that the advertising of medical devices (being healthcare products) must comply with very stringent criteria, be subject to a very precise control and possible penalties, even serious, but I disagree on the need for prior authorization.

Moreover, I believe that if the EU legislator had deemed an authorization regime necessary, it would have introduced it in the new Regulation, like what happened in the drug directives.

I also believe that, in the context of a single market, it is penalizing, also from the point of view of competition, to subject Italian companies to an authorization regime in a legal framework in which goods and services circulate freely, including online. This could have been adequate in other historical periods, but not in the current one, in which the organization of the market itself, even in its online channels, makes its management very complex.

What do you think are the most critical regulatory aspects of health advertising on social media?

Social media is the most mobile and editable thing there can be. A static legal regime such as the authorizing one clashes when applied to instruments designed according to a logic of dynamism: it is precisely the chosen legal architecture, in my opinion, that is not in step with the times, as well as not in compliance with the Community legislative framework.

That said, we are all well aware of the possible risks associated with incorrect or non-transparent advertising and certainly the adoption of a preventive regime allows you to check the message a priori and take time to assess its possible repercussions on public health.

But it is a very stringent and limiting system, which can negatively impact Italian companies, which find themselves operating within a very competitive market. With this in mind, I believe that it would be necessary to introduce a subsequent control thought in a completely different way and structured on the basis of other dynamics.

Is the European advertising framework in general harmonized?

From a European point of view, advertising began to be regulated with Directive 84/450 / EEC on misleading advertising, which has been applied to both B2C and B2B. Subsequently, the regulatory path forked. On the one hand, Directive 2006/114 / EC survived for the aspects concerning B2B advertising, implemented in Italy by Legislative Decree 145/2007.

On the other hand, consumer advertising has been absorbed within the broader Directive 2005/29 / EC on unfair commercial practices, which also includes advertising, to be understood as a message with promotional purposes.

Is there a specific discipline on advertising on social channels?

No. And we couldn’t, in my opinion, even have it. But all the general legal principles of correctness, transparency and truthfulness of the advertising discipline are also applied to social networks.

We must specify that social media are only a means of advertising and, as such, are regulated with the same legal instruments as all other communication channels. In fact, control does not depend on the medium but on the content of the advertising message.

Regulation (EU) 745/2017 – Article 7

In the labeling, instructions for use, making available, putting into service and advertising medical devices, the use of texts, names, trademarks, images and figurative or other signs that could induce the user or patient in error regarding the intended use, safety and performance of the device:

  • attributing to the device functions and properties it lacks;
  • creating erroneous impressions about the treatment or diagnosis, functions or properties that the device lacks;
  • failing to inform the user or patient about a potential risk associated with the use of the device according to its intended use;
  • proposing uses of the device other than those declared as part of the intended use for which the conformity assessment was carried out.

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