Authorized Representative , Non-European Medical Device manufacturers who are exporting their products to ITLAY and rest of European countries must designate an Authorized Representative, that is established in the European Community, to fulfill one aspect of the requirements for CE marking.
The Authorized Representative performs certain duties under the European Medical Devices Directives and acts as a legal interface between the Medical Device manufacturer and the European Union Authorities. This is why AAA CONSULAZIONE was established. AAA CONSULAZIONE ITLAY meet the criteria for CE marking and, more importantly has sufficient experience in Regulatory Affairs to provide this demanding and highly `responsible´ Service!
AAA CONSULAZIONE makes powerful alliances and provides timely, comprehensive solutions for our clients´ protection, benefit and corporate endurance. We strive to provide the best representation in the ever changing maze of European Regulations.
AAA CONSULAZIONE, your products´ first class address, will be synonymous with quality products and compliance with the European Medical Device requirements. Because each client is unique and different, we provides a customized solution for each one.
AAA CONSULAZIONE serves both the Medical Device and the In Vitro Diagnostic Medical Device industries worldwide. Our clients are successful in their local marketplace and have expanded their expertise into the European arena with MDSS as their Authorized Representative and Regulatory Partner
New Medical Device Regulation (MDR) in Europe
The New European Medical Device Regulation for 2017
In 2016 the European Parliament, the Council and the Commission came to an agreement on the new medical devices regulation (MDR) and on the In Vitro medical devices regulation (IVDR). It is to be expected to enter into force in the first part of 2017.
The concepts are set and manufacturers who do not want to risk the CE mark for their products must evaluate the changes and additions now in order to prepare for a timely implementation.
New CE Mark
It is important to know the new specific requirements for your products and the timelines available to make sure that your products and your company is ready for the “New CE” mark.
AAA CONSULAZIONE is confident that to operate effectively within the constraints of ever changing Medical Device Industry and Medical Device Directives Standards, you need an Authorized Representative who not only represents your company, but does so with your best Regulatory Affairs interests in mind.
Our dedication to our clients is the very reason why you need AAA CONSULAZIONE ITLAY as your “Authorized Representative” for Medical Devices,
The links below will guide you through the papers and regulations concerning Medical Devices. We hope this will give you more insight and understanding of the Medical Device Directives.
From the regulatory point of view, the requirements for the introduction of a medical device on the European market are fulfilled. The CE mark is an indication to show conformity to all obligations for medical devices as required by the Medical Devices Directives. With the CE mark in place your products can be legally marketed in Europe (precisely the EU, EEA and the few other countries having mutual recognition agreements in place).
For the penetration to non-EU markets a Free Sales Certificate must be provided by the manufacturer. The Free Sales Certificate demonstrates from the government that you place products, legally with the CE mark on the European market.
The European Free Sales Certificate (FSC) / Certificate of Marketability, is issued by the Competent Authority of the EU member state where the “manufacturer” in Europe or his authorized representative (EC REP) has his registered place of business. If the manufacturer is not situated in Europe only the Authorized Representative is able to obtain the Free Sales Certificate on behalf of the manufacturer.
Product names and/or model/part numbers
The country you would like to apply for a Free Sales Certificate / Certificate of Marketability
AAA CONSULAZIONE as your Authorized Representative may obtain a Free Sales Certificate for any non European country. Free Sale Certificate can be processed for the following countries:
Algeria, Argentina, Bolivia, Brazil, Cambodia, Chile, China, Colombia, Costa Rica, Ecuador, Egypt, Guatemala, Hong Kong, India, Indonesia, Iran, Israel, Jordan, Kazakhstan, Morocco, Mexico, Nigeria, Panama, Paraguay, Peru, Philippines, Russia, Saudi Arabia, Serbia, Singapore, South Korea, Sri Lanka, Syria, Taiwan, Thailand, United Arab Emirates, Uruguay, Venezuela and Vietnam.