Defining the regulatory class of a medical device

Does the classification of my device have an impact on placing it on the marketing?

Classification of a device is an essential step to determine an optimal regulatory strategy to market the right product, a compliant product, safe and effective in the target markets.

The first step is to establish your classification to define the indication of use and its demands.

The regulations for medical devices may differ depending on the country of marketing, which can have an impact on the classification of your product and the approval process.

The establishment of a regulatory strategy is recommended as early on as the feasibility study phase. It allows you to optimise time to market, obtain a regulatory overview to find out the best possible obstacles and roads, and remove ambiguities. This strategy allows you to get organised based on regulatory critical points in order to find the optimal route.

With nex’strategy, you obtain a full and objective regulatory strategy that includes:

  • Clarification of your product and indications for use;
  • Identification of the class of your target by country, according to its demands;
  • Analysis and interpretation of regulations thus avoiding any ambiguity;
  • Identification of critical regulatory issues that will be essential in the development, industrialisation, manufacturing, and marketing stages;
  • Objective analysis to facilitate decision making;
  • Development of a regulatory simplified strategic plan based on possible routes to access the marketing in target countries and according to an objective timeline.

What are the risks in case of misclassification?

A potential error in the classification of the product may have significant impacts:

  • A product that is non-compliant with regulations;
  • Occurrence of non-compliance with implementation of new tests, if necessary;
  • Negative impact with respect to the relationship with the notified bodies or authorities;
  • Lost time;
  • Financial loss;

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