MEDDEV Guidelines definition

MEDDEV Guidelines means those guidelines published by the European Commission promoting a common approach by manufacturers and notified bodies involved in the conformity assessment procedures according to the relevant annexes of the directives, and by the competent authorities charged with safeguarding public health.
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MEDDEV Guidelines means those guidelines published by the European Commission promoting a common approach by manufacturers and notified bodies involved in the conformity assessment procedures according to the relevant annexes of the Medical Device Directive and other applicable EU directives, and by the competent authorities charged with safeguarding public health.
Sample 1Sample 2Sample 3
MEDDEV Guidelines means those guidelines published by the European
Sample 1

Examples of MEDDEV Guidelines in a sentence

  • E.g. Noti- fied bodies shall take into account relevant MEDDEV Guidelines for all aspects of the assess- ment, since these documents reflect the common opinion of the regulators on the subject.Notified bodies shall have a documented procedure that specifies the activities for the renewal of certificates with due consideration to the change in the state of the art.

  • Causality assessments define the relationship between the use of the medical device (including the medical-surgical procedure) and the occurrence of each adverse event, according to MEDDEV (Guidelines on Medical Devices, Clinical Investigations: Serious Adverse Event Reporting).

  • NGPOD® Global Ltd’s Quality Management System has been composed in line with the following: FDA and Canadian Regulations, ISO standards, IVD & MDD Directive, MEDDEV Guidelines.

Related to MEDDEV Guidelines

  • 2%/25% Guidelines has the meaning set forth in Section 13.

  • Program Guidelines means any and all GLO-approved documents reflecting specific rules and regulations governing the implementation of the Program.

  • Procurement Guidelines means the “Guidelines: Procurement under IBRD Loans and XXX Credits” published by the Bank in May 2004 and revised in October, 2006.

  • Design Guidelines means the Fernkloof Estate architectural design guidelines to control all aspects of design and landscaping of any development within the Fernkloof Estate dev elopment, as amended from time to t ime in terms of the constitution of the MPOA or as required by the Council , a copy of the current draft which i s av ailable for inspection at the offices of the Association;

  • Operating Guidelines means the guidelines for the creation and redemption of Units of a class as set out in the schedule to each Participation Agreement as amended from time to time by the Manager with the approval of the Trustee, and where applicable, with the approval of HKSCC and the Conversion Agent, and following consultation, to the extent reasonably practicable, with the relevant Participating Dealers subject always, in respect of the relevant Operating Guidelines for a Participating Dealer, any amendment being notified in writing by the Manager in advance to the relevant Participating Dealer. Unless otherwise specified, references to the Operating Guidelines shall be to the Operating Guidelines for the relevant Sub-Fund applicable at the time of the relevant Application.

  • Guidelines means the Instructions to Authors available on the Xxxxxxx Science website, as well as the Aims & Scope applicable to the relevant Xxxxxxx Science publication). Xxxxxxx Science’s nominated service provider, Xxxxxxx Science, offers English language support services which Assignor may elect to utilise in respect of the Work by completing the applicable box in Schedule 1: Details of the Work. The provision of such services by Xxxxxxx Science shall be subject to Xxxxxxx 2 [v.122016] Science’s prevailing terms and rates relating to such type of optional support.

  • Modification Guidelines has the meaning provided in Section 2.1(a) of this Single Family Shared-Loss Agreement.

  • Fitch Guidelines means the guidelines, as may be amended from time to time, in connection with Fitch’s ratings of the VMTP Shares.

  • Federal poverty guidelines means the poverty guidelines published annually in the Federal Register by the United States Department of Health and Human Services under its authority to revise the poverty line under section 673(2) of subtitle B of title VI of the omnibus budget reconciliation act of 1981, 42 USC 9902.

  • Applicable Guidelines means the policies of the Bank governing the selection and Contract award process as set forth in this RFP.

  • User Guide means such user guide or document issued or prescribed by us, through any medium, setting out instructions on the use of the EB Services;

  • Valuation Guidelines means the valuation guidelines adopted by the Board, as may be amended from time to time.

  • Consulting Guidelines means the Guidelines on the Use of Consultants by Asian Development Bank and its Borrowers (2010, as amended from time to time);

  • Anti-Corruption Guidelines means the “Guidelines on Preventing and Combating Fraud and Corruption in Projects Financed by IBRD Loans and XXX Credits and Grants”, dated October 15, 2006.

  • Environmental Guidelines means the environmental guidelines and occupational health and safety standards of the World Bank Group as in effect on [Bid Date].

  • Xxxxxx Xxx Guides The Xxxxxx Xxx Xxxxxxx' Guide and the Xxxxxx Xxx Servicers' Guide and all amendments or additions thereto.

  • Fixed guideway means a public transit facility that uses and occupies:

  • Consultant Guidelines means the “Guidelines: Selection and Employment of Consultants by World Bank Borrowers” published by the Bank in May 2004 and revised in October 2006.

  • Treasury guidelines means any guidelines on supply chain management issued by the Minister in terms of section 168 of the Act;

  • User Guides means Sprinklr materials made available to Customer through the support portal to assist users of the Platform, as such materials may be updated during the Term.

  • Bidding Guidelines means the “Tariff Based Competitive-Bidding Guidelines for Transmission Service” and “Guidelines for Encouraging Competition in Development of Transmission Projects” issued by Government of India, Ministry of Power dated 13th April 2006 under Section – 63 of Electricity Act and as amended from time to time;

  • Investment Guidelines means the investment guidelines approved by the Board, a copy of which is attached hereto as Exhibit A, as the same may be amended, restated, modified, supplemented or waived pursuant to the approval of a majority of the entire Board (which must include a majority of the Independent Directors).

  • Credit Guidelines means the policies of Credit Acceptance, relating to the extension of credit to automobile, light-duty truck, minivan and/or sport utility dealers and consumers in respect of retail installment contracts for the sale of automobiles, light-duty trucks, minivans and/or sport utility vehicles including the policies for determining creditworthiness of such dealers and consumers and otherwise relating to the extension of credit to dealers and consumers and the maintenance of installment sale contracts, as in effect on the Cut-off Date and as amended from time to time in accordance with the Basic Documents or in accordance with Applicable Law, attached hereto as Exhibit H.

  • Program Guide The Residential Funding Seller Guide for mortgage collateral sellers that participate in Residential Funding's standard mortgage programs, and Residential Funding's Servicing Guide and any other subservicing arrangements which Residential Funding has arranged to accommodate the servicing of the Mortgage Loans.

  • Clinical practice guidelines means a systematically developed statement to assist

  • Policies and Procedures means the written policies and procedures of the Client in any way related to the Services, including any such policies and procedures contained in the Organic Documents and the Offering Documents.