Both Medical Device Regulation (EU MDR 2017/745) and In Vitro Diagnostic Medical Device Regulation (EU IVDR 2017/746) state that where a non-EU manufacturer places a device on the European market, he shall designate an Authorized Representative in the European Union.
Are you looking for an Authorized Representative in the EU?
Contact us:
+49 176 67510274
info@mdrc-consulting.com
A European Authorized Representative may also be referred to as a EUAR, EC REP, CE REP, EU REP or EAR. All of these are common among medical device professionals, and they denote the same: EU Authorized Representative.
A European Authorized Representative is defined as being any natural or legal person within the European Union who has accepted a written mandate from a non-EU manufacturer to act on their behalf in relation to specified tasks under MDR or IVDR. Specifically, Authorized Representatives play a pivotal role in ensuring the compliance of the devices and in serving as point of contact for the European authorities and Notified Bodies.
MDR and IVDR describe the tasks that can be delegated by the manufacturer to the authorized representative, and the conditions under which this can take place. This relationship should be covered by a precise mandate agreed between the EC REP and the manufacturer. The Authorized Representative shall perform the tasks specified in the mandate. A copy of the mandate shall be provided by the Authorized Representative to the competent authority, upon request.
The Authorized Representative is liable for defective medical devices together with the manufacturer, as well as any manufacturer's incompliance or noncompliance.
MDR and IVDR clearly outline the core of the role of the Authorized Representative and his obligations, which shall be referenced in the mandate. The EU REP mandate shall require, and the manufacturer shall enable, the Authorized Representative to perform at least the following tasks in relation to the devices that it covers:
As per the minimum qualifications, the Authorized Representatives shall have permanent and continuous access to at least one Person Responsible for Regulatory Compliance (also known as PRRC) who has sufficient expertise regarding the European regulatory requirements for medical devices or in vitro devices. The requisite expertise shall be demonstrated by either of the following qualifications:
A) a diploma, certificate or other evidence of formal qualification, awarded on completion of a university degree or of a course of study recognized as equivalent by the Member State concerned, in law, medicine, pharmacy, engineering or another relevant scientific discipline, and at least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices;
B) Alternatively, four years of professional experience in regulatory affairs or in quality management systems relating to medical devices.
MDR and IVDR also describe activities that cannot be delegated to an authorized representative, and that may not be part of the mandate between a manufacturer and an Authorized Representative. Examples include requirements related to the design of a device, the quality management system, or the drafting of technical documentation; these are the exclusive responsibilities of the manufacturer.
You may switch your EC REP without invalidating your product approvals in the European Union. However, the change of Authorized Representative requires a proper agreement that defines the arrangements between the manufacturer and both the outgoing and the new EC REP.
Besides, keep in mind that because your EC REP information must be printed on your labeling, switching your European Authorized Representative may incur additional costs as you will need to change labeling and deal with the issue of products that are already on the market.
Both Medical Device Regulation (EU MDR 2017/745) and In Vitro Diagnostic Medical Device Regulation (EU IVDR 2017/746) state that where a non-EU manufacturer places a device on the European market, he shall designate an Authorized Representative in the European Union.
A European Authorized Representative may also be referred to as a EUAR, EC REP, CE REP, EU REP or EAR. All of these are common among medical device professionals, and they denote the same: EU Authorized Representative.
Are you looking for an Authorized Representative in the EU?
+49 176 67510274
info@mdrc-consulting.com
A European Authorized Representative is defined as being any natural or legal person within the European Union who has accepted a written mandate from a non-EU manufacturer to act on their behalf in relation to specified tasks under MDR or IVDR. Specifically, Authorized Representatives play a pivotal role in ensuring the compliance of the devices and in serving as point of contact for the European authorities and Notified Bodies.
MDR and IVDR describe the tasks that can be delegated by the manufacturer to the authorized representative, and the conditions under which this can take place. This relationship should be covered by a precise mandate agreed between the EC REP and the manufacturer. The Authorized Representative shall perform the tasks specified in the mandate. A copy of the mandate shall be provided by the Authorized Representative to the competent authority, upon request.
The Authorized Representative is liable for defective medical devices together with the manufacturer, as well as any manufacturer's incompliance or noncompliance.
We will be happy to act as your Authorized Representative in the EU.
+49 176 67510274
info@mdrc-consulting.com
MDR and IVDR clearly outline the core of the role of the Authorized Representative and his obligations, which shall be referenced in the mandate. The EU REP mandate shall require, and the manufacturer shall enable, the Authorized Representative to perform at least the following tasks in relation to the devices that it covers:
MDR and IVDR also describe activities that cannot be delegated to an authorized representative, and that may not be part of the mandate between a manufacturer and an Authorized Representative. Examples include requirements related to the design of a device, the quality management system, or the drafting of technical documentation; these are the exclusive responsibilities of the manufacturer.
As per the minimum qualifications, the Authorized Representatives shall have permanent and continuous access to at least one Person Responsible for Regulatory Compliance (also known as PRRC) who has sufficient expertise regarding the European regulatory requirements for medical devices or in vitro devices. The requisite expertise shall be demonstrated by either of the following qualifications:
A) a diploma, certificate or other evidence of formal qualification, awarded on completion of a university degree or of a course of study recognized as equivalent by the Member State concerned, in law, medicine, pharmacy, engineering or another relevant scientific discipline, and at least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices;
B) Alternatively, four years of professional experience in regulatory affairs or in quality management systems relating to medical devices.
You may switch your EC REP without invalidating your product approvals in the European Union. However, the change of Authorized Representative requires a proper agreement that defines the arrangements between the manufacturer and both the outgoing and the new EC REP.
Besides, keep in mind that because your EC REP information must be printed on your labeling, switching your European Authorized Representative may incur additional costs as you will need to change labeling and deal with the issue of products that are already on the market.
If you need an EU Authorized Representative contact us:
+49 176 67510274
info@mdrc-consulting.com
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