Placing your product into the European market is contingent upon your compliance with the Medical Device Directive 93/42/EEC. While this Directive is a law to all 27 Member States within the European Union, each Member State has its own way of implementing the Directive within their country essentially by adding regulations to the Directive and creating Local Legislation.
An example of such local implementation of the Directive is now present in Portugal which requires, in addition to the CE marking (as opposed to the essence of the CE marking which is “Free Circulation of Goods”), that Class IIb and III medical devices to be placed on the Portuguese market will go through a Device registration process. This process is similar to the pre-market notification requirement for Class I Medical Devices (as stated in the European Directive MDD 93/42/EEC Article 14) only in Portugal it is applicable for Class IIb and Class III. The devices must be registered online to the Portuguese Competent Authorities according to n.º 3 of l' article 8º-C of the Order in Council nº30/2003 February 14.
In addition to this registration and in accordance with the Decree-Law n.º 273/95, of 23rd of October, all manufacturers of active and non active Classes of IIb and III medical devices will need to communicate their device details to the Portuguese Competent Authorities through their legal entity, including labeling and Instructions For Use information (which are required to be in Portuguese).
Distributors also have requirements to fulfill under the Portuguese regulation. Distributors are required to notify the Competent Authorities of all medical devices they are placing on the Portuguese market. They can communicate this to the Authorities through the online registration database.
Class I medical devices are not exempt. While they do not have to fulfill all the requirements of the Class IIb and III devices, Class I devices are required to complete the registration sheet and Declaration of Conformity on the Portuguese database.
As a non-EU manufacturer of medical devices, the requirements under the Portuguese regulation need to be complete by a legal representative in the Community - a European Authorized Representative.
To complete these requirements, the Authorized Representative will need to be presented with the following:
- EC Declaration of Conformity
- CE Certificate
- Labeling (must be in Portuguese)
- Instructions For Use (must be in Portuguese)
- Technical file
Notifications by Distributor and Manufacturer (or Authorized Representative) are independent and not replaceable.
Third party commercial entities, like distributors, should not register your products for several reasons, a few of which are:
1. By allowing a third party commercial entity to register in your behalf, the manufacturer relinquishes an essential part of his control over his product in Portugal
2. If you decided to end the relationship with your commercial distributor at any point, you would be required to take your product completely off the market until you could re-register that product within Portugal for a second (third, fourth, etc.) time
3. Your third party commercial entity will expect exclusivity, limiting the open distribution of your product
1. For the benefit of non-EU manufacturer, the distributor must be cleared from any regulatory affairs
2. The manufacturer should register their products with the Italian database through his appointed European Representative
Local Legislations, such as this one, are growing rapidly in Europe and strengthen the need for a professional European Authorized Representative present at all times.
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