Medical device manufacturing organizations are scattered all around the globe. Some of them are localized into countries, while others have managed to spread their operations globally, and many are still struggling to do so.
Those medical device manufacturing organizations that want to expand their operations in Europe have to comply with the continent’s rule, especially if they do not have a physical presence in Europe. For such organizations, it is necessary to appoint an Authorized Representative (abbreviated as AR or EC REP). This Authorized Representative shall be responsible for displaying those medical device manufacturing organizations’ compliance to the European authorities. Hiring this Authorized Representative is a condition to which these organizations must show compliance if they want to market their devices in the European market.
Major Role of EU Authorized Representative
The EU Authorized Representative’s major role is to connect his medical device manufacturing organization with the relevant National Competent Authorities (or Ministries of Health). This will help the medical device manufacturing organization to ensure its compliance within Europe.
Appointing a Distributor as EU Authorized Representative
It is legal for the companies to select their distributors as their Authorized representatives. However, a distributor is not usually competent intellectually and functionally. He cannot show compliance to the obligatory responsibilities which lie upon him as an Authorized Representative. Also, he is not well-aware of regulatory affairs, although he may know about sales and marketing. Therefore, it is recommended to hire an independent and competent representative who has a thorough knowledge of regulatory affairs rather than sales and marketing for this specific purpose.
What Impact does EU MDR have on an Authorized Representative?
EU Medical Device Regulations impose more risks and obligations upon European Authorized Representatives. In case of medical device malfunctioning, EU MDR shall hold the EU Authorized Representative liable. He shall face joint and individual liability. Hence, the EU Authorized representative’s responsibility is to work vigilantly for the organization that has recruited him.
Getting Access to the European Market without an EU Authorized Representative
The medical device manufacturers can’t gain access to the EU market without an Authorized Representative because MDR requires Notified Bodies to appoint an Authorized Representative in advance for those medical device manufacturing organizations situated outside Europe. Once the company appoints an Authorized Representative, the Notified Body shall grant it a C.E. certificate.
For those medical device manufacturers that do not have an Authorized Representative, there is a high probability that these devices can be held at the customs.
Name of the EU Authorized Representative on Packaging, Labeling, & IFUs of the Device
Organizations situated outside the EU shall display their Authorized Representative’s name and mailing address after the authorized EU Authorized Label logo. This information should be displayed on:
Competent Authority & Inspection of the Authorized Representative
It is up to the Competent Authority to check the Authorized Representative at any given time. The Competent Authority shall conduct this assessment via regulatory inspections to determine whether if:
- The Authorized Representative is fulfilling his role
- He has direct access to client documentation or not (for example, Technical File and Design Dossier)
- He has prepared processes to carry out his designated role of Authorized Representative.
Replacing the Appointed EU Authorized Representative
It is allowed for a medical device manufacturing organization to change its appointed Authorized Representative. However, this process can be very costly as changing the EU Authorized Representative means changes in device labeling, IFUs, and exterior packaging.
Need an Authorized Representative?
The EU MDR will not allow manufacturers to market their medical devices in the EU market without an Authorized Representative. This condition is implied upon all the medical device manufacturers across the globe. In this regard, TSQ Asia & Middle East is facilitating those Asian medical device manufacturers who are interested in reaching out to the European market. With vast experience in the medical device manufacturing industry and having an impeccable knowledge of standards and regulations such as EU MDR, our Authorized Representative will help you in showing compliance to the MDR’s requirements. Visit our website tsqasia for further details.