The international contract in the field of medical devices. What are its advantages?
The internationalization process goes through trade with other parties from different countries.
EU reg. 2017/745 has standardized product disciplines between states of the European Union, however, civil and commercial aspects that are not codified by supranational rules remain freely determined between the parties.
The European market provides for harmonization of rules regarding the manufacture and marketing of medical devices while there has been no similar regulation for marketing.
In international business dealings, it is good practice for a contract to be drawn up between the parties so as to prevent possible conflicts between the parties involved. In fact, should one party complain of some non-performance by the other, it would suffice to appeal to the contractual provisions.
In fact, in the event of a dispute, the court that has a text (the stipulated contract) is able to determine a decision on the basis of what has been written and established by the parties, where the respective obligations of the counterparties are easily inferred. It would, on the other hand, turn out to be complex to establish the obligations of the parties in case of conflict, since in this case the judge would have to base his judgment on other means of evidence such as e-mails and witnesses.
In the case where a contract is not concluded between the parties and therefore the applicable law is chosen, there are two cases:
In the non-EU sphere, the rules of private international law vary from country to country and therefore one appeals to the law chosen by the judge who first will be bold. The choice of law applied will, therefore, also change the outcome of the judgment.
In the EU context, the 1980 Rome Convention applies, according to Article 4 of Rome I, “To the extent that the law governing the contract has not been chosen in accordance with Article 3, the contract shall be governed by the law of the country with which it is most closely connected. However, where a part of the contract is severable from the rest and presents a closer connection with another country, the law of that other country may exceptionally apply to that part of the contract.”
Accordingly, it is desirable for the parties to define the substantive law applicable to the contract through ad hoc clauses.
Among the most important advantages in entering into an international contract is the possibility of regulating “quality management.”
Consider the case where an Italian distributor wants to contract a distributor of another nationality. In this case, the manufacturer complies with the obligations set forth in Art. 10 EU reg. 2017/745 while the distributor complies with the obligations set forth in Art.14.
Therefore, it is necessary for the parties to cooperate and agree in advance on how the obligations are to be fulfilled.
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