Authorised Representative Agreement Medical Device
The Regulation (MDR) applicable to licensed agents and the new Medical Devices Regulation (MDR) 2017/745 will be fully implemented from 26 May 2020. The responsibilities of agents and manufacturers will be changed as technical documents will have to meet the requirements of the new regulations. To learn more about how to prepare your file for the new Medical Devices Regulation, click here. DG Sanco seems to have the idea of turning the agent into an extension of unpaid market surveillance. Not paid, not quite? Paid by the manufacturer, that is. In addition to the legal arguments you have already made in your article, I have moral objections. The EU representative is subject to EU law. However, the device manufacturer is domiciled outside EU jurisdiction and may decide not to cooperate with EU authorities. In order to minimize the agent`s exposure to the fact that he goes to the beneficiary side of a manufacturer`s debts, the sanction clauses provide for an appeal. Confidentiality should be covered in the agreement between your company and the agent in accordance with the Medical Devices Directive, which stipulates that all ERs, including the authorities, are required to respect the confidentiality of all information provided and provided in the technical file. With respect to the first point, the MEDDEV makes it clear that the relationship between the manufacturer and the agent is part of the delegated powers, which means that the agent must exercise those powers with a certain degree of independence. Here are the points that the authorities of the Member States expect in an agreement of authorized representatives.
This has implications for the current agreements, because I know from my own experience of the authorized rep agreements that almost none of the agreements there meet the following requirements that I have put in a slightly lighter language for a simple reading: yes, according to the MDD. The Medical Devices Directive requires that the manufacturer and the agent`s names be printed on the device`s label, so that both parties are held liable. In order to avoid dual liability insurance for the same device, the agent is insured in addition as part of the manufacturer`s global policy. – «The agent must have the knowledge, skills and resources to assess and verify the knowledge and resources mentioned above.» I note that the Medical Devices Directive, since it has been outside the control of DG Enterprises and is under the control of DG Sanco, is slowly but surely moving away from the principles of the `new approach` (now the new legal framework or NLF). With the adoption of Decision 768 and the NLF, the EU intended to harmonize the differences in the `new approach` directives which were the result of 25 years of system development and the «We know better» enthusiasm of specific sectoral divisions within the European Commission. Now it`s DG Sanco that`s starting to go in its own direction. Decision 768 concerns the responsibilities of economic operators, including the manufacturer and agent. I conclude, after seeing your article, that the meddev is not in compliance with this legally binding document, which introduces new unwanted responsibilities. I will be very interested to see if the EU Member States will accept this interpretation. Agreement, plenipotentiary, agent, compliance, non-compliance, agency notified Dear Han, I agree with your observation that the authorities require the AR to do things that do not follow the regulatory logic of the NLF.