EU Authorized Representative
HealthLink Europe Provides Authorized Representative Services
EU rulings issued a Medical Devices Directive (MDD), stipulating that all foreign manufacturers without a permanent legal address or business in a member state must appoint an Authorized Representative in the EU. The address and contact numbers of the Representative must appear on the labeling or inserts of all medical devices.
Utilizing HealthLink’s European Distribution Center (EDC) + services, shipments can be made and special added-value services can be administered to help manage costs. Moreover, the HealthLink EDC+ service can operate an Authorized Representative service to carry out certain tasks required by the Medical Devices Directive (MDD) on our customer’s behalf. Many clients prefer to maintain their independence with respect to importers and distributors; therefore HealthLink has the regulatory requirements to represent customers effectively as their official European Authorized Address.
Upon engaging HealthLink Europe as your Authorized Representative we would carry out the following activities:
- Notify The Netherland’s authorities concerning its address and the category of the device(s) being placed in the EU-market by The Customer, in accordance with Article 14
- Appoint a “safety officer” in compliance with current EU member states currently requiring such or equivalent officer
- Provide and maintain an accessible telephone line to fulfill the terms and responsibilities agreed upon in this Agreement. This telephone line will be maintained on working days, (for distributors/agents/end-users), between 08:30 and 17:00 MET.
HealthLink’s Responsibilities are as follows:
- HealthLink Europe will deal with all customers’ inquires, complaints and other information from distributors and/or end-users sources by confirming the receipt of said information, notifying The Client immediately & forwarding the information to: The Client’s address.
- Following prior approval from The Client, HealthLink Europe will report, when necessary, occurrences to the Medical-Products-Observation-and-Report-System of the EC.
- Upon the request of The Client, HealthLink Europe will use its best effort to procure product(s) that have possibly been the cause of a customer complaint and return said product(s), either directly or via customer / distributor, to The Client for evaluation purposes, thus meeting the requirements stipulated by the FDA.
- Upon prior written request, HealthLink Europe will transmit legal advice on behalf of The Client.
- HealthLink Europe will use its best effort in observing all changes in legislation occurring within the European Union concerning medical devices and report these to The Client. HealthLink Europe will provide copies of all correspondence created in the execution of these responsibilities and identification of any other “safety officers” appointed to fulfill the responsibilities under the EU directive, to The Client’s head office.