IVDR definition
Examples of IVDR in a sentence
An individual Vehicle Distance Record (IVDR) report for each trip that includes the information required in IFTA Procedures Manual Section P640.
Het “broertje” voor invitrodiagnostica die hier zeer mee vergelijkbaar is, zal niet separaat worden behandeld, Verordening (EU) 2017/746 (IVDR, herschikking).
In the event a non-conformity to EU MDR, IVDR is identified during the checks performed, CONTRACT ACCEPTOR shall immediately and no later than 1 (one) business day after the checks, inform in writing the CONTRACT GIVER.
Tempus shall identify, secure and maintain (or, as applicable, procure the identification, securing and maintenance of) any and all approvals, licenses, permits and certificates required by Applicable Law (including (EU) 2017/746 (IVDR)) which are or may become applicable to Tempus or Approved Subcontractors in connection with any Activities to be performed by any of them under this Agreement and any Task Order.
Manufacturing and hence Agreement Dendreon Corp and Kirin Brewery Co. Supplier Template Agreement MDR & IVDR Easy Medical.
Manufacturers may have to adhere to any relevant regulations specified, for example for in vitro medical devices / medical devices, the current ▇▇▇▇/MDD respectively and from May 2022 the new IVDR or from May 2021 the new MDR.
ANNUAL FEES PRODUCTS & FEES* Based on permanently updated Declaration(s)_of_Conformity of your devices as per IVDR requirements.
All Goods supplied must comply with the European Directive 98/79/EC on In Vitro Diagnostic Medical Devices (IVDMD) (1998) or Regulation (EU) 2017/746 (IVDR) as applicable and as updated and amended from time to time.
POSITION RESPONSIBILITIES: · Establish, implement, and maintain the QMS Per ISO 13485, 21CFR820, IVDD, IVDR, MDD, MDR and other applicable regulatory requirements to secure an ISO 13485:2016 certification.
The addition of such additional devices is considered only possible if for the same devices or its substitute device9 a formal application has been lodged with the IVDR Notified Body before 26 May 2025, and written agreement for the IVDR conformity assessment conducted before 26 September 2025.