With the implementation of the new EU Medical Device Regs in May come a lot of changes that will have a big impact on the way we do business in the EU. One of those changes is the responsibilities of the AR, or Authorized Representative. It's especially important for companies to understand how the role and responsibilities of their AR is changing, and that they make sure whoever they've contracted as their AR has the means to implement and adhere to the new regulations.
What is an AR?
An Authorized Representative is a legal entity designated by non European Union (EU) manufacturers, to represent them in the EU and ensure their compliance with the European Directives. A non EU manufacturer must hire an AR if: 1) They do NOT have a physical company location within any of the EU member states, and 2) They wish to sell their product in the EU. This representative must be a natural-born citizen of the EU, or a legal person/entity established within the EU (such as RQMIS).
In the days of old, if someone had a P.O. box in an EU member state they could essentially call themselves an "AR" and represent a non EU manufacturing company. However under the new EU MDR, this is no longer possible and the responsibilities of the AR have increased tenfold. It is critical that your AR understands the new regulations and is ready to comply with them to represent your business abroad.
EU MDR Implementation Timelines
For medical devices (MDs) the transition period will end on 26 May 2020, the “Date of Application” (DoA) of the MDR
For in vitro diagnostic devices (IVDs) the transition period will end on 26 May 2022, the DoA of the IVDR
What has changed?
CE Marking Requirements: Content and analysis of the CER (Clinical Evaluation Report) need to be conducted more in-depth thanpreviously required
Supply Chain Traceability and Unique Device Identifiers (UDIs): The UDI will now allow all stakeholders to access basic information on devices through the European Database on Medical Devices (EUDAMED)
Traceability: Distributors and importers must cooperate with manufacturers or authorized representatives to achieve an appropriate level of traceability of devices
Transparency: The new EUDAMED database will include information on UDIs, the registration of economic operators (except for distributors) and devices, certificates, clinical and performance investigations, post-market surveillance, vigilance and market surveillance. EUDAMED will also be used by manufacturers to report incidents, and as a platform for EU/EEA authorities to cooperate and exchange information.
Is your EU Authorized Representative ready? Do they have the expertise to comply with these new responsibilities?
Under the new regulations, your Authorized Representative will be responsible for the following:
1. Documentation Check
Verify the Declaration of Conformity
Review the Technical Documentation
Check where applicable that an appropriate conformity assessment exists
Keep the previous documentation (Declaration of conformity, Technical Documentation, certificates issued by Notified Body and amendments) at the disposal of competent authorities (at least 10 years; 15 for implantable devices)
2. Registration Check
Verify that the manufacturer is complying with the registration of the Unique Device Identification according to Article 27
Ensure the registration of the device is performed according to Article 29
Ensure the registration of the manufacturer, Authorized Representative, and importers are completed according to Article 31
3. Audit Support
In case requested by the competent authorities, the Authorized Representative should give all the information and documentation necessary to prove the conformity of a device, in an official language
Keep the manufacturer informed of any request coming from the competent authorities
Verify that the competent authorities receive the samples or is given access to the device
Cooperate with the competent authorities for any preventive or corrective action taken to cut or mitigate the risks posed by devices
4. Vigilance Report
Immediately tell the manufacturer about complaints and reports from healthcare professionals, patients and users related to suspected incidents performed by their device
Terminate the mandate if the manufacturer acts contrary to its obligations under this regulation
6. Administrative tasks
The specific national notification requirements
Need an AR?
With an office in Spain, RQMIS is already serving as the AR for a number of clients - and we can be yours too!