Parallel importation of medical devices: implications and applicability of Article 16 examined
Parallel importation of medical devices is a concept borrowed from the pharmaceutical sector, applied de facto in the medical sector.
The essential activity is the marketing of a medical device by a third party other than the legal manufacturer in the territory of a Member State where the manufacturer is already marketing the same device.
The concept of parallel importation has to be contextualized within the Community legal framework on medical devices (Regulation EU 2017/745 or MDR).
The Regulation establishes that medical devices should be compliant with the European safety and quality standards, regardless their distribution channel.
Consequently, medical devices parallelly imported should meet all European requirements, such as the CE marking, certifying the compliance with the general performance and safety requirements. Parallel distributors are bound to ensure that the devices are marketed in compliance with the local regulations.
In particular, they must ensure that the imported devices did not undergo any change compared to the originals, that are correctly labelled and accompanied by the documentation required for their safe use.
On this regard, the Regulation introduces Article 16, a novelty compared to previous regulations.
Importer or Manufacturer?
In particular, article 16.1 defines which actions/operations carried out on a medical device imply that a different subject, such as a distributor or an importer, is considered as a “manufacturer” and therefore takes on the obligations of this figure.
This happens if a distributor, an importer or another natural or legal person:
- a) puts a device on the market with their name, their trade name or their trademark, except for the cases where a distributor or an importer makes a deal with a manufacturer, based on which the manufacturer is indicated as such in the label, and is responsible for the compliance with the manufacturer’s obligations according to the regulation.
- b) changes the intended use of a device already placed on the market or put into service;
- c) changes a device already placed on the market or put into service in such a way that its conformity to the applicable provisions may result as compromised.
The legal figure that carries out this kind of changes on devices already placed on the market is considered as the legal manufacturer of the product, taking on the obligations and responsibilities related to the device distribution. They are therefore obliged to follow all conformity assessment procedures, prepare any technical documentation, and obtain the CE marking for the modified device.
But which are the changes mentioned under letter c) involving the applicability of this article?
Article 16.2 specifies the cases where specific operations of importers and distributors are not considered changes in the device that could affect its conformity.
Some examples of such changes are the relabeling because of the translation of the information provided by the manufacturer and required to market the device in the concerned Member State, as well as the changes in the outer packaging of a device, provided that the repackaging is carried out in such conditions that the original condition of the device is not affected. In these cases, the changes would not affect the conformity of the device, as per 16.1, letter c).
Even in this case, it should be clarified what is meant by repackaging, and to which extent this does not affect the original condition of the device.
The MDCG 2021-26 – Questions and Answers on repackaging & relabelling activities under Article 16 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746 – has the purpose of orienting economic operators carrying out any of the operations listed under article 16.2, letters a) and b), on the topic of relabelling and repackaging of devices, defining the conditions to be met to market a device in a given Member State. Please refer to the guideline for an in-depth analysis.
Parallel importation and MDR
One can see that this topic is complicated by the convergence of several aspects: regulating frameworks (like the right conferred by the trademark), application contexts (such as the good functioning of the European Union internal market) and the regulators’ goals (such as a high level of safety and health).
The final result leads to extremely insecure situations for the applicability of Article 16, with relevant consequences on the appropriate distribution and importation of medical devices.
In such a context, that is at the same time complex and characterized by specific and limiting requirements, when the latter are not met, the practice of parallel importation risks to be non-existent. To protect patients and ensure medical device quality, it is essential that parallel importation is strictly monitored, in compliance with the European and national laws. Only in this way it will be possible to combine market competitiveness with safe and reliable medical devices.
