Responsibilities of the EU Rep
- Access and availability of your most up to date technical file
- Act within 24 hours in case of incidents and Field Safety Corrective Action (FSCA) reporting.
- First point of contact for the competent authority
Due to the increased liability under the MDR/IVDR, Qserve has updated her processes and systems to meet the requirements underlying article 11. Qserve will review your technical documentation and provide support where necessary. Together we ensure that your documentation complies with the regulations. Once completed, your devices will be registered.
Depending on the classification of the device the type of review may vary. For Class I devices the manufacturer has to self-declare the conformity to the MDR/IVDR. For Class II and III, there is Notified Body involved, and only after approval (CE Certificate) the EAR can register the devices.
The roadmap of Qserve's EU Rep
Interested in our Authorized Representative Services?
After completing the form, you will receive the EU Authorized Representative brochure.
We will contact you within 2 business days to help with any questions.
Information request
EU Rep
Qserve’s EU Authorized Representative Service Package
Use of name and registered address within the EU on all product related labelling.
Official appointed contact address for European regulatory agencies.
A thorough review of your EU declaration of conformity and technical documentation.
Preparation and registration of the initial product in the electronic system.
Update listing of product registration in the electronic system.
Assistance in communication between the competent authority and the manufacturer.
Assistance and coordination of complaint handling and incident reporting to the Competent Authorities.
Updates regarding regulatory changes which might impact devices and registrations
Advice on registration strategies
4 hours ad-hoc consultancy