MDCG 2022-16 Guidance on Authorised Representatives under MDR and IVDR
Medical devices regulation
When a manufacturer of a device is not established in a Member State, the device may only be placed on the Union market if the manufacturer designates a sole authorised representative (Article 11(1) MDR and IVDR).
Authorized representatives play a critical role in ensuring device compliance and act as a point of contact within the EU for manufacturers not based in the Union.
This guidance also includes important topics such as:
Designation and Mandate
- A manufacturer not based in an EU Member State must designate a sole authorized representative to introduce their device to the Union market.
- A manufacturer can have multiple authorized representatives for different generic device groups, but only one representative per group.
- The authorized representative's mandate must be accepted in writing. Both the representative and the manufacturer set the structure of their contractual relationship as long as they adhere to the minimum requirements.
- Certain elements of the manufacturer's responsibility cannot be delegated, although the representative can assist with these tasks.
- Importers must verify that the manufacturer has designated an authorized representative. This designation can be confirmed using relevant documentation, the EUDAMED database, or by directly contacting the manufacturer or the representative.
Registration and Verification obligations
a) Authorised Representative’s Registration Obligations:
- They must register their details in EUDAMED according to Articles in MDR and IVDR. pdate their registered information within a week of any changes.
- Verify the accuracy of the submitted data annually after the initial submission and biennially thereafter.
- The guide titled ‘EUDAMED: Economic Operator user guide’ gives more details on the registration procedures.
b) Verification Obligations Towards the Manufacturer:
- Authorised representatives should ensure manufacturers have met their UDI and device registration duties in EUDAMED.
- Manufacturers cannot delegate their registration responsibilities to the authorised representative.
Minimum tasks & responsibilities of the Authorised Representative (AR)
- They must verify the presence and correctness of the EU declaration of conformity and technical documentation.
- If any doubts arise regarding the conformity assessment procedure of a device, the manufacturer must be informed.
- They must retain a copy of technical documents, EU declarations, and relevant certifications. These should be available for 10 years after the last device's market introduction, and 15 years for implantable devices.
- Manufacturers must always provide authorised representatives with updated documentation either in hardcopy or electronically.
- Upon request from competent authorities, authorised representatives must present documentation that proves device conformity in the designated official Union language.
- There are additional documentation specifics in various annexes of the regulations.
- Custom-made device statements can be made by either the manufacturer or the authorised representative and must also be retained for the same durations.
- Open communication between the manufacturer and the authorised representative is essential.
- The representative should always have access to updated documents and should prove such access during inspections.
- They must forward any requests for device samples to the manufacturer and ensure compliance.
- Cooperation with competent authorities is necessary, especially for preventive or corrective actions concerning devices.
- They must also quickly inform the manufacturer of any complaints or suspected incidents reported by healthcare professionals or users related to the device they represent.
Liability
- The authorised representative is liable for defective devices if the manufacturer, not based in a Member State, fails to meet obligations under Article 10 of the Regulations.
- The representative's liability depends on:
• The manufacturer's liability for the defective device being established.
• Proof that the manufacturer did not fulfill obligations under Article 10 MDR/IVDR.
- The representative should ensure the manufacturer meets obligations like having sufficient financial coverage.
- Courts will decide on liability matters.
- The representative has the same rights to defend itself as the manufacturer.
Termination of the mandate
- The authorised representative can terminate the mandate if the manufacturer breaches its obligations.
- Termination applies to all devices of the same generic group, not individual devices unless removed from the market.
- On termination, the representative must notify the relevant authority and detail the reasons for termination.
Change of AR
- Procedures for changing representatives should be defined in an agreement.
- A tripartite agreement should exist under Article 12, unless impractical (e.g., due to the prior representative's bankruptcy).
Person Responsible for Regulatory Compliance (PRRC)
- Representatives must have at least one PRRC with expertise on regulatory requirements.
- The PRRC for an 'outside EU' manufacturer and a representative cannot be the same individual.
- No need for a PRRC for 'legacy devices'.
Market Surveillance
- Authorised representatives might be consulted during market surveillance measures.
- They might need to provide documentation/information to authorities.
- Authorities can conduct announced and unannounced inspections.
Our expertise
Since the arrival of Regulation 2017/745, new requirements have been requested and are part of the documentation to be presented to the notified body. CSDmed brings its expertise and a methodical approach to its customers, manufacturers, importers and distributors of medical devices, thanks to a team of specialized experts and consultants, who will be able to handle the MDR transition in its entirety.
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