With the adoption of the European Regulations 2017/745 MDR (Medical Device Regulation) and 2017/746 IVDR (In Vitro Diagnostic Regulation), the regulations for medical devices and in vitro medical devices have changed dramatically.
With the MDR (Medical Device Regulation), the figures of economic operators were, at last, regulated; figures that were not fully considered in the previous European directive.
In the MDD (Medical Device Directive) only the figures of the manufacturer and the authorized representative were regulated, while with the new MDR (Medical Device Regulation) the figures of the importer and the distributor, which were not regulated in the MDD (Medical Device Directive), were also regulated.
In the MDD (Medical Device Directive) the authorized representative had a very narrow and contained discipline, it happened that very often the figure of the authorized representative was mistakenly assumed by the one who acted as the importer.
With the MDR (Medical Device Regulation) there is a more regulated definition of the obligations and role of the authorized representative, consequently the role of the authorized representative is more understood.
But who is the authorized representative?
An authorized representative is “Any natural or legal person established in the Union who has received and accepted from the manufacturer, established outside the Union, a written mandate authorizing him or her to act on behalf of the manufacturer in relation to certain activities with respect to the manufacturer’s obligations under the MDR.”
It is clear from the definition that there is a difference in the role of the authorized representative established in the MDD (Medical Device Directive) and MDR (Medical Device Regulation), i.e., the assumption of the role of the authorized representative through a written mandate. This element is reiterated in Article 11(2) where the framework states that the designation constitutes the mandate of the authorized representative and is valid only if accepted in writing.
The written mandate is nothing more than a contractual form under international law, so one must take into account which language is considered legally binding. The contract can, of course, be drafted in several languages, but there must be only one language, chosen by both parties, that is binding.
The second element that needs to be taken into account is what is the applicable discipline; if there are, for example, doubts of interpretation, the discipline of a country determined by the parties applies.
A third element that needs to be considered is where the dispute is going to be settled; the parties can either choose a court to settle the dispute or work out alternative solutions.
The alternative solutions that the parties can choose are:
- Conciliation chamber, which is generally less expensive;
- International mediation;
- The arbitration clause where the counterparties define that if there is a dispute, arbitrators will be appointed to decide the dispute. The arbitration clause allows for a choice of competent judges; however, it is much more expensive than the previous alternatives. the international contract entered into must contain the elements stipulated as legal obligations by the Medical Device Regulation (MDR).
Articles 11 and 12 of the MDR (Medical Device Regulation) regulate the roles and duties of the authorized representative.
The authorized representative, in fact, has obligations that intervene before placing on the market, such as: declarations of conformity, technical declaration etc.
In addition, the authorized representative can ask the manufacturer for access to the technical file or a part of it, access to the technical file can create issues related to the protection of internal know-how.
The authorized representative must, also, explicate whether the manufacturer has carried out the declaration of conformity, the contract should, therefore, contain this possibility of ” control”; for example of an audit within the manufacturer’s production site.
But can the agent terminate the mandate?
As Article 11 paragraph 3 letter e-h points out, the authorized representative has the obligation to terminate the mandate if the manufacturer acts contrary to the obligations imposed by the MDR (Medical Device Regulation), consequently the authorized representative must be well acquainted with the MDR (Medical Device Regulation).
Relevant element is Article 11 Paragraph 5, it states that the authorized representative is jointly and severally liable before the law, on defective medical devices on a par with the manufacturer.
But what is meant by joint and several liability?
Joint and several liability occurs when the jointly and severally liable parties, in this case there are two the manufacturer and the authorized representative, are called upon to compensate a damage or pay the penalty to the competent authority or the consumer who received the damage.
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