Manufacturer of Record definition

Manufacturer of Record shall have that meaning set forth for “Manufacturer” in 21CFR§820.3.
Sample 1Sample 2
Manufacturer of Record means, with respect to a medical device, the natural or legal person that Regulatory Authorities in a jurisdiction consider to be responsible for the design, manufacture, packaging and labelling of a medical device placed on the market in such jurisdiction, regardless of whether these operations are carried out by that person or on his behalf by a Third Party.
Sample 1
Manufacturer of Record means the entity that is responsible for a product’s design, manufacture, packaging, labeling, distribution, and regulatory compliance (both pre-market and post-market compliance) regardless of whether these operations are carried out by the entity or on its behalf by another Person.
Sample 1

Examples of Manufacturer of Record in a sentence

  • Such Licence shall include appropriate technology transfer obligations under which XYZ and the Manufacturer of Record shall develop a mutually agreed plan of activities and deliverables to ensure such successful Technology Transfer (the “Transfer Plan”) in order to ensure that the Manufacturer of Record will be able to produce and commercialize the Product.

  • Manufacturer is a Manufacturer of Record and has certain responsibilities pertaining thereto as provided herein for all Products that are Finished Devices.

  • Such Licence shall include appropriate technology transfer obligations under which XYZ and the Manufacturer of Record shall develop a mutually agreed plan of activities and deliverables to ensure such successful Technology Transfer (the “Transfer Plan”) in order to ensure that the Manufacturer of Recordwill be able to produce and commercialize the Product.

  • Therefore, Numet Engineering (part of Rolls-Royce Civil Nuclear Canada Ltd) is the Manufacturer of Record for these pumps.Code ReconciliationIt is understood that the items to be installed in an ASME Section III Class 1, 2, or 3 applications will be manufactured in accordance with the latest revision of the ASME code in effect at the time of manufacture.

  • In countries where Bio-Rad is designated as the Manufacturer of Record for the IVD Kits, Bio-Rad shall appoint Oncocyte as its contract manufacturer subject to the definitive manufacture and supply agreement for the IVD Kits to be negotiated and executed by the Parties pursuant to Section 8.2 in the event the IVD Kits Option is duly exercised.

  • Therefore, Numet Engineering (part of Rolls-Royce Civil Nuclear Canada Ltd) is the Manufacturer of Record for these pumps.Once it has been established that an item is environmentally qualified (EQ), it is necessary to ensure that successive purchases of the item shall be equivalent to the qualified item.

  • Oncocyte will be designated as the Manufacturer of Record for the RUO Assays and will be responsible for all attendant responsibilities, including: (i) all product specifications, design control, and manufacturing; and (ii) product maintenance such as documenting complaints and investigations, recall review and reporting, labels and labeling, and for reviewing changes for product impact.

  • HJL shall maintain a Medical Device Establishment Registration (as defined under the Act) as Manufacturer of Record and Specifications developer for the Products, as is required.

  • The Company will be the Manufacturer of Record, except where OEM has Products manufactured under paragraph 8.4 or manufactures Products under paragraph 17.6 (where an effective remedy is not available to OEM under paragraph 8.4).

  • Annex 2.1(b) sets out the OEM Products, the Manufacturer of Record of the OEM Products, the term of the respective contracts between Biotronik and the Manufacturer of Record of the OEM Products that may impact Acutus, and the countries where the OEM Products may be sold as of the Effective Date of this Agreement.

Related to Manufacturer of Record

  • Retailer of Record means the Retailer who is listed in FortisAlberta’s records through the procedures outlined in the Terms and Conditions, and thereby recognized by FortisAlberta and the Settlement System Code, as a particular Customer’s Retailer for a Point of Service at a particular time;

  • Customer of Record means the person that applies for utility service and is identified in the account records of a public utility as the person responsible for payment of the public utility bill. A customer may or may not be an end user, as defined herein.

  • Teacher of record means a teacher who meets all of the following:

  • Authorized distributor of record means a pharmaceutical wholesaler with whom a manufacturer has established an ongoing relationship to distribute the manufacturer's prescription drugs. An ongoing relationship is deemed to exist between such pharmaceutical wholesaler and a manufacturer, as defined in Section 1504 of the Internal Revenue Code, when the pharmaceutical wholesaler has a written agreement currently in effect with the manufacturer evidencing such ongoing relationship, and the pharmaceutical wholesaler is listed on the manufacturer's current list of authorized distributors of record.

  • Owner of record The meaning set forth in the System Description.

  • Lot of record means any lot, the description of which is properly recorded with the Register of Deeds, which at the time of its recordation complied with all applicable laws, ordinances, and regulations.

  • Version of Record is defined as the final version of the Contribution as originally published, and as may be subsequently amended following publication in a contractually compliant manner, by or on behalf of the Publisher.

  • Architect of Record means the architect licensed by the State who has the contract responsibility for the Project, who designs and prepares the construction documents from which the building is constructed, and who signs the required documents.

  • Shareholder of Record means the record owner of shares issued by an Investment Company or, in the case of joint ownership of such shares, all record owners, as designated (1) in the initial account application, or (2) in writing accompanied by a signature guarantee, or (3) pursuant to procedures as set forth in the Application.

  • Clinical record means a legible electronic or hard-copy history that documents the criteria established for medical records as set forth in rule 441—79.3(249A). A claim form or billing statement does not constitute a clinical record.

  • Client record means collected documentation of the behavioral health services provided to and information gathered regarding a client.

  • Research record means any data, document, computer file, computer diskette, or any other written or non-written account or object that reasonably may be expected to provide evidence or information regarding the proposed, conducted, or reported research that constitutes the subject of an allegation of research misconduct. A research record includes, but is not limited to, grant or contract applications, whether funded or unfunded; grant or contract progress and other reports; laboratory notebooks; notes; correspondence; videos; photographs; X-ray film; slides; biological materials; computer files and printouts; manuscripts and publications; equipment use logs; laboratory procurement records; animal facility records; human and animal subject protocols; consent forms; medical charts; and patient research files.

  • Broker Dealer of Record means GWM Limited or any successor or replacement thereto or any other entity appointed as broker dealer of record in accordance with the terms of the Broker Dealer of Record Agreement.

  • Address of record means the designated address recorded

  • Batch Record means the production record pertaining to a Batch.

  • patient record means a written account of all services provided to a patient by the home health agency, as well as other pertinent information necessary to provide care.

  • Master Batch Record means the document, proposed by Lonza and approved by Customer, which defines the manufacturing methods, test methods and other procedures, directions and controls associated with the manufacture and testing of Product.

  • instructions for use means the information provided by the manufacturer to inform the user of the device’s intended purpose and proper use and of any precautions to be taken;

  • System of records means a group of any records under the control of any agency from which information is retrieved by the name of the individual or by some identifying number, symbol, or other identifying particular assigned to the individual.

  • Operation of a System of Records means performance of any of the activities associated with maintaining the SOR, including the collection, use, maintenance, and dissemination of records.

  • Student record means information that constitutes education rec- ords as that term is defined by the Family Educational Rights and Privacy Act of 1974 (20 U.S.C. Section 1232g(a)(4)) [see FL] and information in a record of an applicant for admission to an educa- tional institution, including a transfer applicant.

  • Education Record means those records that contain information directly related to a student and which are maintained by an education agency or institution or by a party acting for the agency or institution.

  • Medical record means any document or combination of documents, except births, deaths, and the fact of admission to or discharge from a hospital, that pertains to the medical history, diagnosis, prognosis, or medical condition of a patient and that is generated and maintained in the process of medical treatment.

  • Health record means the same as that term is defined in § 32.1-127.1:03.

  • Project Record means the separate set of Drawings and Specifications as further set forth in paragraph 4.02A.

  • Educational records means: those official records, files, and data directly related to a student and maintained by the school or local education agency, including but not limited to records encompassing all the material kept in the student's cumulative folder such as general identifying data, records of attendance and of academic work completed, records of achievement and results of evaluative tests, health data, disciplinary status, test protocols, and individualized education programs.