Are you a global medical device organisation without a physical location in Europe? Of course, you are aware of the medical device regulation MDR 2017/745 mandatory requirement to appoint an EU Authorised Representative [(AR) or (EC REP)] to represent your company to the European competent authorities. Remember, this legal obligation is applicable for the marketing of all classes of medical devices, whether or not a notified body is required for CE marking. If you do not appoint a representative, you risk interruption to your supply chain.
Who is the AR?
An AR is any natural or legal entity 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 with regard to the manufacturer’s legal obligations under the Regulations for specific device families. (A manufacturer may have more than one authorised representative!)
What is the written mandate?
The mandate is the agreement document signed by the authorised representative and the manufacturer declaring the specific tasks to be performed by the AR on behalf of the manufacturer. The Authorised Representative will assume and share appreciably more risk and liability than currently assigned under the medical device directive.
What are an AR’s specific legal obligations which require effective collaboration?
As per MDR Article 11 (3), the agreed mandate shall require, and the manufacturer shall enable, the authorised representative to perform the following minimum tasks in relation to the devices that it embodies:
- The AR must verify that the EU declaration of conformity (DoC) and technical documentation (TF) have been prepared and,
- when applicable, that an appropriate conformity assessment procedure has been performed by the manufacturer;
- The AR must keep available a copy of the TF, the EU DoC and, if applicable, maintain a copy of the relevant certificate, including any amendments and supplements, issued according to Article 56 (Certificates of Conformity), at the disposal of competent authorities (CA) for the period of 10 years (15 years for implantables) after the last device has been placed on the market
The manufacturer must enable access for the AR to the current DoC, TF and certificates of conformity for the device family as specified and all updates for 10+ (or 15+) years, including the ability to produce the current version as and when requested by the competent authorities. The AR must fulfil and perform these activities for all device classes, as applicable.
- The AR must register with EUDAMED prior to a conformity assessment requiring notified body involvement and verify that the manufacturer has complied with the EUDAMED registration obligations for UDI for all device classes
- The AR, when requested, must provide the CA with all the information and documentation necessary to demonstrate the conformity of a device, in the official language determined by the Member State
The mandate should specify who is responsible for obtaining and updating the translated conformity documentation and how the AR will be allowed access to the perform documentation assessments and verifications.
- The AR is required to forward to the manufacturer any request by a competent authority for samples, or access to a device and verify that the competent authority receives the samples or is given access to the device
- The AR must cooperate with the competent authorities on any corrective or preventative action taken to eliminate or, mitigate the risks posed by the devices for which they are responsible
The mandate should include methods of communication and information exchange according to your internal procedures and timeliness of appropriate actions.
- The AR must immediately inform the manufacturer about complaints from healthcare professionals, patients and end users about suspected incidents related to a device for which they have been designated
The AR and manufacturer will need secure processes and systems for monitoring, capturing, analysing and exchanging complaints data.
Suppose there is a need for a change of authorised representative for a device family. During the transition period, your organisation must communicate and exchange information with both the outgoing and the new authorised representative (MDR Article 12).
Are Authorised Representatives Audited?
The Competent Authority may audit an AR at any time, including unannounced, to determine if they understand their role, have direct access to the manufacturers documentation and have systems in place to ensure fulfilment of its role according to their mandate.
The AR will dictate and manage your relationship as legal manufacturer, including specified liabilities, with the competent authorities.
- Are you ready to begin communicating with and sharing your most valuable company asset, technical file documentation, as obligatory for the next 10 -15+ years for each device?
- Can your regulatory information management system effectively and securely comply with the required 3rd party data exchange?
- Have you upgraded your procedures to incorporate these additional communication and data exchange actions, including staff training?
- Do you have senior management and key stakeholder commitment for supporting these new collaborative commitment activities?
Regulatory professionals, please engage with your internal cross-functional teams, you are the experts in creating the appropriate MDR strategy. Do not let a lack of organisational understanding of the vital importance of the AR collaboration activities negatively impact MDR compliance and therefore successful management of your medical device supply chain.
Next time: Importers
Factsheet for ARs, importers and distributors: https://ec.europa.eu/health/sites/health/files/md_newregulations/docs/importersdistributors_factsheet_en.pdf
Actor registration module: https://ec.europa.eu/health/md_eudamed/actors_registration_en