Eudamed Agreement Annex

The activity described above differs from the specific activities described in paragraph 2, points a) and b). But if this is a specific concern, you should perhaps include the damaged goods management rules in your quality agreement with your dealer. Article 58 of the EU MDR deals with the change of body notified. Article 58 stipulates that the manufacturer must have an agreement with the (new) notified body. In addition, it is stated that the agreement “b) must indicate the date on which the identification number of the outgoing notified body can be indicated in the information provided by the manufacturer… This is an issue that needs to be discussed with your designated organization. There is no time limit in the EU MDR. If the number of a notified organization changes, it must also change the labeling and instructions when accompanied by the CE mark. However, the timetable for changing the number can normally be negotiated and agreed with the notified agency concerned.

To find out if your notified organization`s number is likely to change, contact your notified organization`s account representative or manager. For the four bodies designated by the UK that plan to transfer their certificates to EU-27 offices in the event of a Non-Brexit Deal, it is expected that their numbers for notified bodies will change if there is no agreement on Brexit. Any outsourcing or consultation of external staff must be properly documented, must not involve intermediaries and is the subject of a written agreement including, among other things, confidentiality and conflicts of interest. The notified organization takes full responsibility for the tasks of the subcontractors. We have already signed a quality agreement with a distributor and we have a few doubts about Article 16 (3) – 4). 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 MDD did not comment on this subject, nor did the EU MDR. However, given that Article 1, paragraph 1, of the EU MDR states that “this regulation contains rules for the marketing of equipment …¬†you can read the “Blue Guide” on EU product rules (ref.