The Medical Device Directive (MDD) previously defined the role of the Authorised Representative quite narrowly, often leading to confusion where the importer was mistakenly considered the Authorised Representative. However, the MDR defines the duties and responsibilities of an Authorised Representative more broadly and accurately, giving us some much-needed clarity regarding the role.
Who Is an Authorised Representative?
Any natural or legal entity established within the European Union that has obtained and accepted a written mandate from a manufacturer located outside the EU to act on the manufacturer’s behalf with regard to specific tasks concerning the latter’s compliance with the Regulations is referred to as an Authorised Representative. An Authorised Representative needs to:
Be established in the EU: They must have a physical address in one of the member states of the EU.
Possess a written mandate: The representative’s authority must be outlined in a written agreement provided by the manufacturer.
Carry out specified tasks: This includes keeping track of technical paperwork, monitoring compliance with the MDR, and serving as a liaison with regulatory bodies.
What Is the Need for an Authorised Representative?
Legislators primarily need an Authorised Representative for foreign manufacturers in order to create a legally accountable entity inside the European Union. For example, in the event that a patient sustains an injury as a result of a medical equipment malfunction, the individual can seek reimbursement from the manufacturer. However, it raises legal questions about the patient’s ability to pursue reimbursement if the manufacturer is based outside of the EU. By offering a liable party within the EU, the presence of an Authorised Representative helps in addressing this problem.
Responsibilities and Liabilities of an Authorised Representative
Facilitating compliance and communication between the manufacturer and EU regulatory authorities is the primary responsibility of the Authorised Representative. Other responsibilities include:
1. Verify Manufacturer’s UDI and Registration
It is not possible to delegate the manufacturer’s responsibility to register its information and devices in EUDAMED (MDR/IVDR Article 11(4)). However, it is the responsibility of the Authorised Representative to confirm that the manufacturer has complied with UDI and device registration regulations.
2. Verify EU Declaration of Conformity, Technical Documentation, and Conformity Assessment Procedure
The Authorised Representative has to ensure that the EU Declaration of Conformity and all necessary technical documentation have been prepared correctly. They also have to see to it that the appropriate conformity assessment procedure has been carried out (MRD/IVDR Article 11(3)(a)).
3. Maintain Records
For a minimum of ten years following the final device covered by the declaration’s distribution to the market, the designated representative must preserve copies of the technical documentation, the EU Declaration of Conformity, and any relevant certificates. This time frame lasts for at least 15 years in the case of implanted devices. In addition, copies of scientific opinions and related documents, records of changes, decisions and reports from the notified body, and paperwork pertaining to the manufacturer’s quality management system will have to be retained by the Authorised Representative, depending upon the situation (MDR/IVDR Article 11(3)(b)).
4. Prove That the Documents are Verified
The Authorised Representative must keep lines of communication open with the manufacturer and make sure that all required documentation is accurate and up to date in order to demonstrate compliance. Additionally, they have to prove to the authorities that these evaluations have been carried out.
5. Inform the Manufacturer of Any Complaints
Should patients, healthcare providers, or users report complaints regarding the device, the Authorised Representative must alert the manufacturer right away. (MDR/IVDR Article 11(3)(g)).
6. Collaborate with Competent Authorities
The Authorised Representative shall provide, in an official language specified by the relevant Member State, all information required to prove the device’s compliance upon request from a competent authority. Along with ensuring that these demands are met, they must relay any requests for device samples or access made by the appropriate authority. Additionally, the Authorised Representative must work with the authorities to carry out any corrective or preventive measures that are made to mitigate the risks associated with the devices. This may include cooperating with medical device distributors, importers, and other supply chain partners (MDR/IVDR Article 11(3)(d)) and (MDR/IVDR Article 11(3)(e)).
7. Terminate Agreement Upon Non-Compliance
Since the Authorised Representative assumes liability from the manufacturer, their legal appointment requires the establishment of a formal agreement. Specific requirements outlined in MDR Article 11(3) should be included in this agreement. It should also specify that in the event that the manufacturer violates any Medical Device Regulations (such as IVDR or MDR), the Authorised Representative has the authority to terminate the agreement. This means that if the manufacturer refuses to correct any identified noncompliance, the Authorised Representative shall immediately terminate the contract (MDR/IVDR Article 11(3)(h)).
8. Take Legal Accountability in Case of Defective Products
Authorised Representatives serve as the Manufacturers’ contact person established in the Union and play an important role in ensuring that the products they create comply with regulations for Manufacturers who are based overseas. Owing to their crucial role, the MDR legally holds Authorised Representatives liable for defective products in the event that a Manufacturer based outside of the Union fails to carry out its general obligations. (MDR/IVDR Article 11(5)).
Liability of an Authorised Representative After Termination of Service
Article 12 of MDR/IVDR provides clarity on how manufacturers can change their Authorised Representatives. It has already been discussed how an Authorised Representative is obliged to retain all technical documentation while working with a manufacturer. Manufacturers should also incorporate clauses in their agreements that guarantee the retention of copies of this Technical Documentation by their former Authorised Representatives. This is because concerns regarding devices that are still on the market will continue to fall under the purview of the former Authorised Representative. Furthermore, any post-market feedback should still be forwarded to the manufacturer by the former Authorised Representative.
PRRC
Every medical device manufacturer, with the exception of micro and small businesses (those with fewer than fifty employees or a revenue of less than 10 million euros), is required by Article 15 of the MDR to have its own PRRC. They might also employ a third-party PRRC. The maker must then have permanent and continued access to this PRRC.
The responsibilities of a PRRC include:
- Verifying the compliance of devices per the quality management system
- Monitoring the development of the technical documentation and performing routine inspections
- Ensuring adherence to post-market surveillance requirements
- Supervising obligations related to incident reporting
Key Takeaways
To sum up, the introduction of MDR and IVDR has led to Authorised Representatives shouldering even more responsibility regarding compliance and safety in the medical device sector. They are in charge of keeping track of important documentation and facilitating communication between regulatory bodies and manufacturers. This also means that Authorised Representatives are jointly and severally liable, with the importer and the Manufacturer in case of defective devices. Careful selection of Authorised Representatives and a strong collaborative relationship can enhance regulatory compliance and ultimately protect public health.
Are you a medical or IVD device manufacturer looking to enter the European market? An experienced and reliable European Authorised Representative like MedQAIR can make the process a breeze.
We can serve as your company’s Authorised Representative before European authorities, playing the vital role of a liaison for the EU MDR Regulation.
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