Manufacturer of Record definition

Manufacturer of Record shall have that meaning set forth for “Manufacturer” in 21CFR§820.3.
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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

  • 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.

  • During the IVD Phase, Oncocyte will be designated as the Manufacturer of Record for the IVD Kits within the Territory and Bio-Rad will be designated as the Manufacturer of Record for the IVD Kits outside the Territory.

  • 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.

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;

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

  • 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. Any linking, collection or aggregation of self-archived Contributions from the same Work is strictly prohibited. Appendix “Author’s Reuse Rights” The Publisher acknowledges that the Author retains the ability to copy, distribute or otherwise reuse the Contribution, without the requirement to seek specific prior written permission from the Publisher, (“Reuse”) subject to and in accordance with the following provisions: (a) Reuse of the Contribution or any part of it is permitted in a new edition of the Work or in a new monograph or new textbook written by the same Author provided that in each case the new work is published by the Publisher under a publishing agreement with the Publisher; and (b) Reuse of the Version of Record (as defined below) of the Contribution or any part of it is permitted in a thesis written by the same Author, and the Author is entitled to make a copy of the thesis containing content of the Contribution available in a repository of the Author’s awarding academic institution, or other repository required by the awarding institution; an acknowledgement should be included in the citation: “Reproduced with permission from Springer Nature”; and (c) any other Reuse of the Contribution in a new book, book chapter, proceedings or journal article, whether published by the Publisher or by any third party, is limited to three figures (including tables) or a single text extract of less than 400 words; and (d) any further Reuse of the Contribution is permitted only to the extent and in so far as is reasonably necessary: (i) to share the Contribution as a whole to no more than 10 research colleagues engaged by the same institution or employer as the Author for each colleague's personal and private use only; (ii) for classroom teaching use by the Author in their respective academic institution provided that the Contribution or any part of it is not included in course packs for sale or wider distribution to any students, institutions or other persons nor any other form of commercial or systematic exploitation; or (iii) for the Author to use all or parts of the Contribution in the further development of the Author's scientific and/or academic career, for private use and research or within a strictly limited circulation which does not allow the Contribution to become publicly accessible nor prejudice sales of, or the exploitation of the Publisher's rights in, the Contribution (e.g. attaching a copy of the Contribution to a job or grant application).

  • 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.

  • Address of record means the designated address recorded

  • Master Batch Record or “MBR” shall mean, with respect to each Presentation of Clinical Product or Commercial Product to be Produced hereunder, a formal set of instructions for the Production of each Presentation of such Product. The MBR shall be developed and maintained in Xxxxxx’x standard format by Baxter, using Celator’s master formula and technical support.

  • 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.