European Authorized Representative

Yes. A medical device or IVD manufacturer established outside the European Union must designate an EU-based Authorized Representative (EC REP) to place applicable products on the EU market. The EC REP acts on behalf of the manufacturer for defined regulatory responsibilities and serves as a key contact for European Competent Authorities.

An EC REP represents a non-EU manufacturer for specified regulatory matters within the European Union. Responsibilities can include verifying regulatory documentation, maintaining required records, supporting registration, communicating with Competent Authorities and Notified Bodies, and assisting with vigilance, incident reporting, and Field Safety Corrective Actions.

An EC REP must maintain access to specified regulatory documentation, including copies of the manufacturer’s Declaration of Conformity, technical documentation, and applicable CE certificates and associated documents. The representative must retain the required records for the applicable regulatory period and make them available to authorities when requested.

The EC REP must retain specified regulatory documentation for the periods required under the applicable EU framework. The provided requirements identify a retention period of 10 years for general medical devices and 15 years for implantable devices. Manufacturers should ensure their EC REP arrangements support these documentation-retention obligations.

Yes. The EC REP’s name and address must be represented on applicable medical device labeling, packaging, instructions for use, and relevant regulatory documentation. Manufacturers should ensure that the representative’s details are correctly incorporated into product information before placing the device on the EU market.

An EC REP represents a non-EU manufacturer for defined regulatory obligations within the European Union, while a Notified Body performs conformity assessment activities when required under the applicable regulatory pathway. The EC REP does not replace the Notified Body. Manufacturers may need both depending on the device and conformity assessment requirements.

An EC REP can support and manage applicable registration activities with EU National Competent Authorities on behalf of a non-EU manufacturer. Registration requirements depend on the device, regulatory framework, and applicable national or EU processes. Manufacturers should ensure their representative has the information and documentation required for the relevant registration.

An EU Authorized Representative can represent manufacturers of both medical devices and IVDs, provided the representative can fulfill the applicable regulatory responsibilities under the relevant EU frameworks. Medical devices are regulated under EU MDR, while IVDs are regulated under EU IVDR, so documentation and compliance obligations may differ between product categories.

The EC REP acts as a regulatory communication channel between the non-EU manufacturer and European Competent Authorities. When authorities request information, the representative can coordinate the response and provide or facilitate access to required documentation. The manufacturer must maintain appropriate records and cooperate with the EC REP to address regulatory requests.

Yes. EC REP responsibilities can include supporting vigilance activities, incident communications, and Field Safety Corrective Actions (FSCA). The representative may coordinate regulatory communications and assist with information requests related to product safety. Manufacturers must maintain appropriate post-market processes and provide the EC REP with information needed to fulfill its regulatory responsibilities.