CRO & IVDR · Representation
EU Representation & PRRC
An EU regulatory contact for manufacturers established outside the Union, with responsibilities defined in a written mandate. PRRC services are assessed separately against Article 15.
When this service helps
For non-EU manufacturers appointing or changing their authorised representative, and eligible organisations arranging external PRRC availability.
Scope of work
EU authorised representative
Mandate review, verification of the required documentation and regulatory communications within the Article 11 scope.
PRRC arrangements
Confirm eligibility, qualifications, availability and role separation before agreeing the service.
Ongoing coordination
Maintain agreed records and coordinate product changes, authority enquiries and vigilance communications. UK and Swiss representation are scoped separately with local partners.
What you receive
- Mandate and responsibility schedule
- A written scope covering the products, contacts, document access and escalation process.
- Document and registration review
- A record of required information, verification findings and applicable registration actions.
What to prepare
Manufacturer details; product and certificate list; declaration of conformity; technical-file access; label and IFU versions; existing representative arrangements and contact procedures.