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If your organization does not have a physical presence in Europe, but you want to sell medical devices in Europe, you should employ an Authorized Representative (also abbreviated as EC REP or AR) to showcase your company’s compliance to European authorities. It is now a requirement that you must retain an E.A.R on condition that you market your medical devices in Europe.
EU Authorized Representative Role
European Authorized Representative works as a connection between your company and the relevant national Competent Authorities (Ministries of Health) to ensure your compliance in Europe. Moreover, selected representative will make sure following:
- Contribute with some medical device registrations, as needed.
- E.A.R needs to be branded on the device labeling all through Europe.
- Prepare an updated copy of concerned Technical File or CE Declaration of Conformity accessible for inspection by a Competent Authority, as needed.
- Support your company with Incident and Field Safety Corrective Action (FSCA) reporting, in collaboration with the organization and its distributors.
You can appoint a distributor as your Authorized Representative in Europe; but, it is not endorsed because most distributors are not equipped intellectually and functionally to comply the obligatory responsibilities of the. In its place, it is recommended to appoint an independent representative that emphasize on regulatory affairs, instead of sales and marketing. Common Questions
MDR Impact on Authorized Representative European Authorized Representatives will bear more risk and obligation under Europe’s new Medical Device Regulation (MDR). The E.A.R. will face joint and individual liability for malfunctioning medical devices, so organizations can anticipate that E.A.R will monitor organization’s compliance more systematically.
Download our white paper to learn more about the MDR.
Accessibility to European market without the role of an E.A.R.
With the new MDR, if you are not based in Europe, the Notified Body needs appointment of an E.A.R. in advance, after that they will render a CE certificate. Compliance with the relevant Directive is obligatory for any device located in the EU market; consequently, engaging and recognizing your selected representative is vital. If you do not employ a E.A.R, your devices may be stationed at the customs.
Name of the Authorized Representative on labeling, packaging and IFUs
The organization outside EU must exhibit the name and mailing address of the E.A.R. on the device label, exterior packaging and/or IFUs (Instructions for Use). The name and mailing address of the Authorized Representative should be exhibited following the authorized E.A.R. logo.
Inspection of Authorized Representative by Competent Authority
A Competent Authority can examine an Authorized Representative at any point of time through regulatory inspections to identify if they comprehend their role, have direct accessibility to client documentation for instance the Technical File and Design Dossier and have processes prepared to make sure it can bear out its role as an Authorized Representative.
Change of Appointed Authorized Representatives
One can definitely change E.A.R. without canceling the medical devices endorsements in Europe. But, remember that because E.A.R. must be published on device labeling, exchanging can be rather expensive as the organization will be required to update labeling and cope up with the concern of devices that are by now present on the market.
Why choose TS Quality as your European Authorized Representative?
TS Quality is trustable Authorized Representative for medical devices and IVDs, representing several medical device companies globally.
Our knowledgeable and competent consultants will assess your Technical File, ease the process of registration of a medical device or IVD, as needed, and answer to any queries or apprehensions from the Competent Authorities.
You will have protected online right of entry to all your documents and regulatory evidences, together with labeling information, technical files, language requirements, applicable directives, plans, helpful material and more.
Our huge proficiency with European regulations, will facilitate an effective and well-organized registration route. We provide recurrent and comprehensive updates to all our Authorized Representation customers about significant regulatory updates for European Market . Along with our European offices, we have offices in the Asia region and collaborate with various bodies worldwide. We can help you professionally irrespective of the time zone.
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