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- Von Ardenne Institute of Applied Medical Research
- NB Confirmation Letter
NB Confirmation Letter
NB Confirmation Letter
- Application and Agreement: The letter confirms the receipt of a formal application and a signed written agreement with the manufacturer, Von Ardenne Institut für Angewandte Medizinische Forschung GmbH, for devices under MDR.
- Device Identification: Devices are categorized into two tables: those for which the NB is responsible for surveillance and those for which it is not yet responsible. The document specifies devices covered by certificates under previous directives (AIMDD/MDD) that expired between 26 May 2021 and 20 March 2023.
- Transition Timelines: The document outlines transition timelines for compliance with MDR, including deadlines for different classes of devices, such as Class III custom-made implantable devices by 26 May 2026, and other classes by 31 December 2027 or 2028.
- Validity and Renewal: The confirmation is valid until 30 September 2025 and will be renewed regularly.
- Device Details: Table 1 provides details of devices under MDR application, including the IRATHERM®1000M, classified as Class IIa under MDD, with specific certificate references.
- Revision History: The document includes a revision history, noting the initial issue date as 18 April 2024.
Catalog excerpts
SLG Pruf- und Zertifizierungs GmbH Unser Zeichen Bearbeiter Datum (E-Mail: [email protected]) Confirmation of the status of a formal application, written agreement, and appropriate surveillance in the framework of Regulation EU 2023/607 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices This letter confirms that, SLG Pruf- und Zertifizierungs GmbH, a Notified Body (NB) designated against Regulation (EU) 2017/745 (MDR) and identified by the number NB 0494 on NANDO, has received a formal application in accordance with Section 4.3, first subparagraph of Annex VII of MDR and has signed a written agreement in accordance with Section 4.3, second subparagraph of Annex VII of MDR with the following manufacturer: Von Ardenne Institut fur Angewandte Medizinische Forschung GmbH SLG Pruf- und Zertifizierungs GmbH Burgstadter Str. 20 09232 Hartmannsdorf T + 49 3722 7323 - 0 F + 49 3722 7323 - 899 E [email protected] I www.slg.de.com Dipl.-Ing. Kay-Uwe Schult Dipl.-Ing. Thomas Frank Bettina Hahnel Kuhnert Deutsche Bank AG Chemnitz VAT-ID DE 140 855 197 Sparkasse Chemnitz
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The devices covered by the formal application and the written agreement mentioned above are identified in the Tables below. Table 1 identifies the devices for which an MDR application has been received, written agreement concluded and for which the NB is also responsible for appropriate surveillance of the corresponding devices under the applicable Directive. Table 2 identifies the devices for which an MDR application has been received and a written agreement concluded, but the NB has not yet taken the responsibility for appropriate surveillance of the corresponding devices under the applicable...
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SLG Pruf- und Zertifizierungs GmbH Table 1: Devices covered by this letter and for which the NB is also responsible for appropriate surveillance of the corresponding devices under the applicable Directive:
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SLG Pruf- und Zertifizierungs GmbH Confirmation Letter Revision History Date
Open the catalog to page 4All Von Ardenne Institute of Applied Medical Research catalogs and technical brochures
IS013485 Certificate EN1 Page
IRATHERM®1000M Brochure4 Pages
