Since authorised representatives and manufacturers are jointly and severally liable if the documentation does not comply with European conformity standards, it is of the utmost importance that a RA has a thorough understanding of the relevant directives, standards and more. DG Sanco seems to have the idea of transforming the trustee into an unpaid extension of market surveillance. Not paid, not quite? Paid by the manufacturer, that is. Beyond the legal arguments you have already put forward in your article, I have moral objections. What I observe is that since the Medical Devices Directive came under the control of DG Enterprise and under the control of DG Sanco, it has slowly but surely moved away from the principles of what used to be called the `new concept` (now The New Legislative Framework or NLF). With the adoption of Decision 768 and the NLF, the EU intended to harmonise the differences between the New Approach directives, which were the result of 25 years of development of the system, and the enthusiastic “We know better” of some sectoral divisions within the European Commission. Now it`s DG Sanco who is starting to go in his own direction. Decision 768 is very specific as regards the responsibilities of economic operators, including the manufacturer and the authorised representative. Reading your article, I come to the conclusion that Meddev does not comply with this legally binding document, which introduces new undesirable responsibilities. I will follow with great interest whether the EU Member States accept this interpretation. Why do I need a proxy? Medical device manufacturers established outside the EU must have an authorised representative in order to sell their products within the European Union. This applies to manufacturers of all medical devices (classified into four main categories according to the EU MDR 2017/745): Agreement, authorised representative, authorised representative, conformity, non-conformity, notified body What is an authorised representative? A European authorised representative (also known as a RA or CE REP) is a legal person that acts as a link between a manufacturer established outside the EU and a competent national authority (Ministry of Health) within the EU. The authorised representative acts within the European Union on behalf of the manufacturer.
They ensure that products sold on the EU market comply with European directives. – “In the event of manifest non-compliance on the part of the manufacturer, who could assume the responsibility of the authorised representative and the manufacturer refuses to rectify, the authorised representative shall have the right to terminate his contract with the manufacturer. The authorised representative is even obliged to terminate the contract if the non-performance of the manufacturer`s obligations leads him to infringe national law.. . . .