AR & PRRC
AR & PRRC Services
Manufacturers located outside of Europe are required to appoint an Authorized Representative (AR or EC-Rep) to represent them to European competent authorities. EC-Rep has similar pre- and post-market obligations as manufacturers and acts as a liaison between the competent authority of the European member states and manufacturers. Under the European Medical Device Regulation (MDR), such obligation shall be performed under the supervision of a qualified PRRC, who possesses the requisite expertise in the field of medical device.
As of 26 May 2021, the EU MDR has entered into force, but a necessary MRA between Switzerland and European Union is still pending. As a result, all manufacturers located outsides of Switzerland are required to appoint a Swiss Authorised Representative to continuously trade and coordinate market surveillance activities. For more on this topic, see the blog “Pending MRA of CH-EU”.
Below you can find the necessary information regarding Authorised Representative:
- Definition of Authorised Representative
- Roles & Responsibilities of Authorised Representative
- Information Requested from the Manufacturers
- The Name and Address of Authorised Representative
- Why choose us as your Authorised Representative?
- Frequent Asked Questions
- Our Services & Fees
Definition of Authorised Representative
Means any natural or legal person established within the European Union who has received and accepted a written mandate from a manufacturer, located outside the Union, to act on the manufacturer’s behalf in relation to specified tasks with regard to the European Medical Device Regulation (MDR) and European in vitro Diagnostic Medical Device Regulation (IVDR).
Roles & Responsibilities of Authorised Representative
- Verify that the EU declaration of conformity and technical documentation have been drawn up and that manufacturer has carried out an appropriate conformity assessment procedure;
- Registers itself to European electronic system (Eudamed) and obtains a single registration number (SRN) for the foreign manufacturer;
- The manufacturer shall use the SRN when applying to a notified body for conformity assessment and for accessing Eudamed;
- Verify that manufacturer has complied with the registration obligations to the UDI system (Unique Device Identification) and registration of devices;
- In response to a request from a competent authority, provide that competent authority with all the information and documentation necessary;
- Forward to the manufacturer any request by a competent authority of the Member State;
- Cooperate with the competent authorities on any preventive or corrective action;
- Immediately inform manufacturers about complaints and reports from healthcare professionals, patients and users.
Information requested from the manufacturer
- EU declaration of conformity;
- Copy of the label, packaging and instruction for use (in all languages requested by the countries where the device is marketed);
- Notified Body certification (except Class I non-sterile, non-measuring or non-reusable surgical instruments);
- Post market surveillance process and data, vigilance reports and complaints, processes and data;
- Technical documentation relevant to market surveillance investigation being undertaken by the Member State;
- Relevant clinical data / notification;
- Details of any distributors / suppliers putting the CE marked devices on the market;
- Incident reports and corrective actions taken.
The name and address of Authorised Representative
- On the device label acc. To MDR/IVDR, however, shall be additionally on the instruction for use (IFU) acc. To MDD/AIMDD/IVDD;
- On the EU declaration of conformity;
- Be submitted to European database (Eudamed);
- Be on the certificates issued by notified body.
Why choose us as your Authorised Representative?
- Our experienced consultants will review your Technical Documentation, register your medical device to national competent authority or Eudamed when available;
- We respond to any requests or concerns from the European Competent Authority and forward the information to the manufacturer and vice versa;
- Our vast expertise with European and Chinese regulations and the linguistic capability with Chinese and English, facilitate smooth and efficient registration process and communication flow;
- We provide frequent updates to the manufacturers with regulatory changes focused on Europe;
- Manufacturers have full online access to their technical documentation and regulatory intelligence information including guidance, recommendation and more.
EC-REP Services & Fees Prior CE-marking
After signing off a service contract we review the clients’ technical documentation and quality management system, choose the suitable notified body, select the conformity assessment procedure, write the understandable English technical documentation and align with the notified body until obtaining the CE mark in a timely manner.
EC-REP Services & Fees Post CE-marking
After the EU Authorised Representative mandate is signed off, we officially represent our clients in European Union as Authorised Representative with fulfillment of our roles and responsibilities such as verifying the EU declaration of conformity, device technical documentation, registering itself in the Eudamed in order to obtain a SRN for the client and serve as a liaison between European competent authorities and the foreign manufacturers with regard to complaint and safety relevant communication and etc.
Interested in our services? Please contact us
Frequent Asked Questions
What is the role of the Authorized Representative under the MDR?
Authorized Representatives will take on more risk and liability under Europe’s new Medical Device Regulation (MDR). The authorised representative will be held jointly and severally liable for defective medical devices, so you should expect that your representative will monitor your compliance more thoroughly.
What happens if we do not appoint an authorised representative?
Notified Body requires appointment of an authorised representative before they issue a CE certificate. Even for the Class I medical device without a need engaging Notified Body, appointing an authorised representative is essential because compliance with the applicable Directive or Regulation is mandatory for any device placed in the EU market. If you do not appoint a rep, your products may be stopped at the border.
Can a Competent Authority inspect my Authorised Representative?
Yes. A Competent Authority can inspect an Authorised Representative at any time to determine if they understand their role, have direct access to manufacturers’ technical documentation and have processes in place to ensure it can fulfill its role as an Authorised Representative.
Can I change Authorised Representatives after I appoint one?
Yes. You may switch your authorised representative; however, since the current Authorised Representative (name and address) is printed on your device label and the EC Certificate, you need to be aware of the impact of such change.