ANSWERED ON THIS PAGE:
· Whatare the responsibilities of an EU Authorized Representative (ECREP)?
· CanI appoint a distributor as my representative?
· Whathappens if I want to change my EC REP?
Interested in obtaining CE certification to sell your medicaldevices in Europe? If your company does not have a physicallocation in the EU, you are required to appoint an AuthorizedRepresentative, also referred to as an EC REP, to represent yourcompany to European authorities. You must retain an EC REP as longas you sell your devices in Europe.
What is the role of an EU AuthorizedRepresentative?
Your European Authorized Representative serves as a liaison betweenyou and the national Competent Authorities (Ministries of Health).Additionally, your appointed representative will:
· Assistwith certain device registrations, as required
· Beidentified on your product labeling throughout Europe
· Makea current copy of your Technical File or CE Declaration ofConformity available for inspection by a Competent Authority, uponrequest
· Assistwith Incident and Field Safety Corrective Action (FSCA) reporting,in cooperation with you and your distributors
It is possible to appoint a distributor as your AuthorizedRepresentative in Europe, but it is not recommended because mostdistributors are not prepared to fulfill the mandatoryresponsibilities of the EC REP. Instead, select an independentrepresentative that will focus on regulatory affairs, rather thansales and marketing. Read more about the benefits of hiring anindependent firm to act as your EC REP in Europe.
Why choose SUNGO asyour European Authorized Representative?
SUNGO isthe largest Authorized Representative for medical devices and IVDs,representing more than 1,000 device companies worldwide.
· Ourexperienced consultants will review your Technical File, registeryour medical device or IVD, as required, and respond to any or concerns from the Competent Authorities.
· Youwill have secure online access to all of your documentation andregulatory information, including technical files, labelinginformation and symbols, language re, directives,guidelines, and more.
· Ourvast expertise with European regulations, registering thousands ofdevices, facilitates a smooth and efficient registrationprocess.
· Wesend frequent updates to all of our Authorized Representationclients with important regulatory updates focused onEurope.
· Inaddition to our European offices, we maintain offices in the US,Canada, Japan, Korea, Brazil, and many other places worldwide. Wecan serve you efficiently regardless of your time zone.
Ask us about our special 3-year and "deferred payment" packages fornew European representation clients.
Common Questions
What happensif we do not appoint an EC REP AuthorizedRepresentative?
Your Notified Body re of an EC REP before they will issue a CE certificate.Compliance with the applicable Directive is mandatory for anydevice placed in the EU market; therefore, engaging and identifyingyour chosen representative is essential. If you do not appoint arep, your products may be stopped at the border.
Do we haveto put the name of the Authorized Representative on our labeling,packaging and IFUs?
Yes. You must list the nameand address of the Authorized Rep on the product label, outerpackaging and/or Instructions for Use. The name and address of theAuthorized Representative should be shown next to the official ECREP logo.
Can aCompetent Authority inspect my AuthorizedRepresentative?
Yes. A Competent Authority caninspect an Authorized Representative at any time to determine ifthey understand their role, have direct access to clientdocumentation such as the Technical File/Design Dossier and haveprocesses in place to ensure it can fulfill its role as anAuthorized Representative.
Can I changeAuthorized Representatives after I appoint one?
Yes. You may switch your ECREP without invalidating your product approvals in Europe. However,keep in mind that because your EC REP must be printed on yourlabeling, switching can be somewhat costly as you will need tochange labeling and deal with the issue of products that arealready on the market.
What is therole of the Authorized Representative under theMDR?
Authorized Representativeswill take on more risk and liability under Europe's new MedicalDevice Regulation (MDR). The EC REP will be held jointly andseverally liable for defective medical devices so you can expectthat your representative will monitor your compliance morethoroughly. Download our 15-page white paper to learn more aboutthe MDR changes.
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