Eudamed Agreement Annex

A complete definition of the applicable regions can be found in the European Commission`s guidelines, the `Blue Guide`. >>>> link here. For Switzerland, there is also the EU-Switzerland agreement on mutual recognition of compliance assessment, which includes medical devices. >>> link here. There is only one producer at a time within the meaning of the regulations. The manufacturer is the person who fulfills the general obligations set out in section 10 and all other obligations to the manufacturer, including the mention of his name and address on the device and in the instructions; is registered in EUDAMED as a manufacturer, etc. In accordance with section 16, paragraph 1, point (a), as long as you enter into an agreement with the manufacturer under which the manufacturer is identified as such on the label and is responsible for complying with the requirements imposed on manufacturers in the regulation. You can make available on the market a device under your name, trade names or trademarks without accepting Dener`s obligations. The EU MDR does not deal with this issue. Any restrictions on the modification of the old MDD certificates most likely stem from the internal procedures of the notified body or the agreements it has entered into with its competent authority or with the notified group of operations.

Your designated organization is the best organization to answer your question. Please take into account the European Commission`s guidelines on this matter. >>> link in brief: if there is a withdrawal agreement, your company will be able to continue to place its devices on the EU market after the date of Brexit, on the basis of the UK certificate of the body notified until the end of the withdrawal agreement. If there is no withdrawal agreement, called a no deal, your company will not be able to continue to place its devices on the EU market after the date of Brexit, based on the UK certificate from the notified body. Only with a certificate issued by an EU-27 notified body. However, for devices already on the EU market before Brexit, they can be put into service until 27 May 2025 (depending on their shelf life). Please read Article 120, paragraph 4 of the EUMDR.