The common mistake is the assumption that such matters are not regulated – the assumption is of course erroneous as the promotion of medical devices is governed by several EU Directives, most of which are of general application, as well as the EU member states national laws implementing such Directives. Ultimately, the real challenge resides in the identification of the applicable provisions and their implementation to the specific cases.
The European Commission recently tackled this matter, amongst other new provisions, by adopting two proposals for new regulations, new proposal on medical devices and new proposal on in-vitro diagnostics medical devices. The new proposals are expected to gradually come into force from 2015 to 2019.
However, what are the applicable rules till the above new regulations repeal the current Directives?
The Medical Device Directive 93/42/EEC provides the following basic provisions:
1. Only CE marked medical devices may be promoted and placed on the market (Article 2)
2. Non-CE marked medical devices may be exhibited at trade fair and exhibitions (Article 4(3)). However, they must be clearly marked to be for Demo purposes only and that they are not to be “available to the public” (e.g. – “Any supply of a product for distribution, consumption or use on the Community market in the course of a commercial activity, whether in return for payment or free of charge”)
3. All information related to the medical device (mostly referring to labels & instructions for use) must be in alignment to the national provisions on language requirements (Article 4) – in practice, this means that all displayed information should be, at the very least, in the official language(s) of the EU member state it is intended to be sold in (other languages are permitted);
4. Medical devices may only be promoted in reference of their intended purpose (Article 1(2)(g)
5. Medical devices may not indicate any markings which may be misleading, in reference to the intended purpose of the device nor be in any way, in conflict with the CE marking or otherwise reduce its visibility and legibility (Article 17(3));
Additional to the Medical Device Directive, other provisions on advertising & promotions may be applicable on medical devices by other EU Directives, such as Directive 2006/114/EC, concerning misleading and comparative advertising or Directive 2005/29/EC concerning unfair business-to-consumer commercial practices.
In spite of not being legally binding as a Directive, the recent MEDDEV 2.5/10 guidance document on European Authorized Representative (EAR) indicates that in addition to the mention of the authorized representative name & address, a copy of the label, packaging and instructions for use with such mention, must be submitted to the designated European Authorised Representative (EAR) to be kept readily available for inspection by national authorities.
As a summary - any medical device, promotional or samples of medical devices to be “made available” on the EU market must be in conformity with the above regulatory frameworks – either on the device, the outer packaging or the IFUs.
To know more about the promotion & advertising rules for medical devices, contact us