Vincenzo Salvatore (pictured below right), head of the healthcare and life sciences focus team at BonelliErede, and colleague, associate, Giuseppe Ragucci (bottom left), explore the implications of the European Parliament’s adoption of the new EU Medical Devices Regulation and how the UK fits in the grand scheme of things given it is no longer in the EU
The new EU Medical Devices Regulations are now in force, but create ongoing uncertainty over the advertising and promotion of innovative new technologies
With the EU Medical Devices Regulation (MDR) now fully applicable, the need for clarity in the advertising and promotion of medical devices has become a critical issue for stakeholders.
The MDR partially addresses the matter by establishing some general rules: for instance, that promotional material for medical devices must be compatible with the device’s intended use.
Article 7 of the MDR establishes that in the advertising of medical devices, it is prohibited to use text, names, trademarks, pictures, and figurative or other signs that are likely to mislead the user (i.e. healthcare professionals) or patient as to the medical device’s intended purpose, safety, and performance by: (a) ascribing functions and properties to the device which the device does not have; (b) creating a false impression regarding treatment or diagnosis, functions, or properties the device does not have; (c) failing to inform the user or patient of a likely risk associated with the use of the device in line with its intended purpose; and/or (d) suggesting uses for the device other than those stated to form part of the intended purpose for which the conformity assessment was carried out.
These provisions are similar to those in consumer protection legislation on the marketing of products in general (e.g. Directive 2005/29/EC on unfair business-to-consumer commercial practices and Directive 2006/114/EC on misleading and comparative advertising).
The uncertainty can lead stakeholders to conduct themselves in ways that expose them to civil and criminal liability
This legislation, given the absence of more-specific rules on the advertising and promotion of medical devices, should be used as general guidelines.
So, in a nutshell, because the MDR lays down only the principles according to which medical devices should be advertised and promoted, and thus does not cover all possible scenarios, stakeholders are left in a state of uncertainty.
The reality is that the applicable legal framework has not changed drastically compared to Directive 93/42/EEC (MDD), which essentially left it to national legislators to regulate the subject by setting and enforcing specific rules.
Given that the MDR repealed the MDD, the fate of national regulations is questionable, especially when it comes to determining whether they are compatible with the current legal framework.
This situation does not make it easier for stakeholders to manufacture and market medical devices across the EU and the UK
That said, any incongruity should probably be considered a matter of national competence.
However, other issues that stakeholders had hoped would be covered by the MDR still need to be clarified at EU level. For example, it is still unclear whether medical devices that are not CE-marked may be advertised.
The implicit general rule in the MDD was that a medical device without CE marking could be advertised only in limited circumstances: article 4(3) of the MDD stated that medical devices without CE marking could be shown at trade fairs, exhibitions, demonstrations, and similar events – which meant that the devices could be advertised in those settings – but said nothing about how they could be advertised, except that the devices were to bear a visible sign clearly indicating that they could not be placed on the market or put into service until they were CE-marked.
Conversely, the MDR has no provision like article 4(3) of the MDD and so stakeholders are lacking even a principle to which to adhere to advertise medical devices under development that are not yet CE-marked.
Intervention at EU level might thus be needed; but in the meantime, the rules on advertising products in general might be applicable.
The uncertainty arising from an incomplete regulation on the advertising and promotion of medical devices at EU level raises several concerns.
First, there is a lack of coherence on the part of the EU legislator, as the issue has been thoroughly regulated in other areas of the life sciences. Consider, for example, the legal framework on medicinal products for human use.
Second, this uncertainty can lead stakeholders to conduct themselves in ways that expose them to civil and criminal liability.
In this latter respect, public attention has been drawn in recent years to the need for transparency in the relationships between companies that provide products and services in the healthcare sector, healthcare professionals, and patients (e.g. the Sunshine Act).
For this reason, all transfers of value between the mentioned parties – especially between companies and healthcare professionals – have been brought under the spotlight.
Neither legal framework provides clear, unambiguous guidance for stakeholders – which means stakeholders are forced to take precautionary measures when advertising and promoting medical devices
Due to the absence of specific provisions, more and more self-regulation is being seen: the goal is to provide stakeholders guidance so they can avoid any liability resulting from conduct in relation to which the rules are lacking.
An example of this approach is the MedTech Europe Code of Ethical Business Practice.
Moreover, this situation does not make it easier for stakeholders to manufacture and market medical devices across the EU and the UK, which is no longer an EU member.
Indeed, the UK appears to have the same approach as the EU when it comes to regulating the advertising and promotion of medical devices (see, for example, the MHRA’s guidance on the post-Brexit regulation of medical devices in the UK.
Given that, ultimately, the EU and the UK share the European medical device market, the situation could well be ripe for fruitful discussion between the two sides.
In conclusion, though it would be incorrect to claim that the advertising and promotion of medical devices are unregulated in the EU and the UK, neither legal framework provides clear, unambiguous guidance for stakeholders – which means stakeholders are forced to take precautionary measures when advertising and promoting medical devices.