If your company does not have a physical location within the EU, Billev Pharma East can act as an authorised representative to effectively assist You in complying with European legal requirements.
Under the MDR (EU) 2017/745 and IVDR (EU) 2017/746, authorised representatives have greater responsibilities and take on significantly more risk and liabilities, therefore you can expect Billev Pharma East to scrutinise your documentation more thoroughly.
As an authorized representative we offer
- development/verification of product technical documentation;
- making the technical documentation available to the notified bodies and competent authorities for inspection;
- assistance in product certification;
- sustainable compliance with EU Commission Regulation and requirements of ISO 13485:2016 related to manufacturing of medical devices;
- guiding and supporting post-market surveillance;
- managing vigilance, including reporting of serious incidents and field safety corrective actions.
A manufacturer established outside the European Union is obliged to appoint an authorised representative within the EU. An authorised representative, known also as EC-REP, is defined as being any natural or legal person established within the European Union who has received and accepted a written mandate from a manufacturer located outside the EU, to act on the manufacturer’s behalf in relation to specified tasks regarding the latter’s obligations under the Regulations. The EC-REP symbol may be found on the label of a medical device, and it indicates who is the European authorised representative.
Authorised representative is the entity to which the authorities and institutions of the Member States may address the obligations set out in the legal requirements for medical devices. With the new Europe’s Medical Device Regulation (MDR) and In-Vitro Diagnostic Medical Device Regulation (IVDR), authroised representative takes on more risk and liability and will be held jointly and severally liable for defective medical devices or IVDs together with manufacturer.
For manufacturers who are not established in the European Union, the authorized representative plays a pivotal role in ensuring the compliance of the devices produced by those manufacturers and in serving as their contact person established in the European Union. Medical devices Regulation (MDR) and in vitro diagnostic medical devices (IVDR) outlines the obligations and introduces enhanced responsibility for the authorized representative. Many of the general obligations of authorised representatives are described in MDR/IVDR Article 11. In addition to the already mentioned obligation to contact the authorities, institutions of the Member States, including the supervisory authorities, the authorised representative has an obligation:
- to verify that the EU declaration of conformity and technical documentation have been drawn up and, where applicable, that an appropriate conformity assessment procedure has been carried out by the manufacturer (MRD/IVDR Article 11(3)(a));
- to keep copies available of all documents and make them accessible to authorities on request. This includes technical documentation, declarations of conformity, and certificates, including their amendments and supplements (MDR/IVDR Article 11(3)(b));
- verify that the manufacturer has registered the requested information in EUDAMED (MDR/IVDR Article 11(3)(c));
- have permanent and continuous access to a person responsible for regulatory compliance (MDR/IVDR Article 15(6));
- to accept a Competent Authority inspection at any time to determine if they understand their role, have direct access to client documentation such as the Technical File/Design Dossier and have processes in place to meet its obligations as an authorized representative;
- ensure that the product is correctly labelled;
- respond in case of a medical incidents;
- cooperate with authorities on preventive and corrective actions, and inform the manufacturer immediately about complaints and authorities’ requests for samples of devices;
- to assist with Incident and Field Safety Corrective Action (FSCA) reporting, in cooperation with manufacturers and distributors;
- to register in EUDAMED to obtain a single registration number (SRN);
- to terminate the mandate if the manufacturer fails to meet its obligations and keep the appropriate authorities informed.
The Regulations also describe activities that cannot be delegated to an authorised representative, and that may not be part of the mandate between a manufacturer and an authorised representative (MDR/IVDR Article 11(4)). Examples include requirements related to the design of a device, the quality management system, or the drafting of technical documentation; these are the exclusive responsibilities of the manufacturer.
The authorised representative should be an independent organisation acting in agreement with the manufacturer. If you are considering appointing an authorised representative for your company, consider that authorised representative:
- has access to the full technical documentation, including information on the project;
- should be kept informed of any changes in legal regulations and should warn your company of the changes well in advance;
- should be able to represent the manufacturer adequately and answer all questions from the Competent Authorities concerning the manufacturer’s medical devices;
- has a proper knowledge of legislation requirements related to manufacturers of medical devices including requirements of ISO 13485:2016;
- is appointed in all information materials: labels, packaging, instructions for use.