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This document is a checklist for the mandatory documents required for performance studies of in vitro diagnostic medical devices according to the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746.
Year:
2017
Region / city:
EU
Topic:
In vitro diagnostic medical devices, Performance studies
Document type:
Checklist
Organization:
European Union
Author:
Unknown
Target audience:
Manufacturers of in vitro diagnostic medical devices, clinical investigators, regulatory bodies
Effective period:
Ongoing
Approval date:
Unknown
Date of changes:
Unknown
Price: 8 / 10 USD
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The product description is provided for reference. Actual content and formatting may differ slightly.
Year:
2023
Region / City:
EU
Subject:
Medical Devices
Document Type:
Regulatory Document
Author:
Medical Device Coordination Group (MDCG)
Target Audience:
National Authorities, Conformity Assessment Bodies, Medical Device Manufacturers
Applicable Period:
N/A
Approval Date:
N/A
Date of Amendments:
N/A
Year:
2024
Region / city:
EU
Subject:
Medical device regulation
Document Type:
Template
Authority / Organization:
Medical Device Coordination Group (MDCG)
Author:
MDCG
Target audience:
Regulatory bodies, notified bodies
Period of validity:
Not specified
Approval date:
January 2025
Date of changes:
Revision 1, January 2025
Year:
2021
Month:
July
Document type:
MDCG guidance document
Issuing group:
Medical Device Coordination Group (MDCG)
Regulatory framework:
Regulation (EU) 2017/746
Related regulation:
Regulation (EU) 2017/745
Subject:
Applied-for scope of designation and notification of a Conformity Assessment Body
Field:
In vitro diagnostic medical devices
Geographical scope:
European Union
Legal status:
Non-binding guidance
Endorsement:
Endorsed by the Medical Device Coordination Group
Year:
2023
Document type:
Position paper
Guidance type:
Best practice guidance
Regulatory framework:
In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746
Annexes referenced:
Annex II, Annex III
Adoption date:
27/02/2023
Version:
V1
Issuing organization:
Team-NB – The European Association of Medical Devices Notified Bodies
Editors:
Team-NB
Geographic scope:
European Union
Target entities:
Manufacturers of in vitro diagnostic medical devices
Subject matter:
Technical documentation submission requirements
Regulatory process:
Conformity assessment
Applies to device classes:
All classes of IVD medical devices
Source type:
Regulatory guidance document
Interpretative basis:
Team-NB interpretation of IVDR
Year:
2023
Region / City:
European Union
Theme:
Medical Device Regulation
Document Type:
Compliance Checklist
Organization / Institution:
[Company]
Author:
[Author Name]
Target Audience:
Regulatory Authorities, Manufacturers
Period of Validity:
Ongoing
Approval Date:
[Date]
Date of Changes:
[Date]
Year:
2024
Region / City:
European Union
Topic:
In vitro diagnostic medical devices, transitional provisions
Document Type:
Declaration
Organization / Institution:
Manufacturer
Author:
Manufacturer
Target Audience:
Regulatory authorities, notified bodies, manufacturers
Validity Period:
Transition period for medical devices
Approval Date:
N/A
Amendment Date:
N/A
Context Description:
Declaration regarding the transitional provisions for in vitro diagnostic devices under Regulation (EU) 2024/1860, outlining the conditions for continued market placement and conformity assessment procedures.
Year:
2024
Region / City:
EU
Topic:
Medical Devices, In Vitro Diagnostic Devices
Document Type:
Confirmation Letter
Body/Institution:
Notified Body (NB)
Author:
Not specified
Target Audience:
Medical Device Manufacturers
Validity Period:
Until 31 December 2029
Approval Date:
Not specified
Revision Date:
Not specified
Year:
Based on Regulation (EU) 2017/746
Region:
European Union
Legislative Framework:
Regulation (EU) 2017/746 (IVDR)
Annexes Referenced:
Annex II and Annex III
Article Referenced:
Article 29
Subject:
In Vitro Diagnostic Medical Devices Technical Documentation Requirements
Document Type:
Regulatory compliance checklist
Scope:
Technical documentation requirements for IVDR conformity assessment
Applicable Device Classes:
Class A, B, C and D (SSP specifically for Class C and D)
Intended Users:
Manufacturers of in vitro diagnostic medical devices
Key Sections:
Device description and specification; Information supplied by the manufacturer; Design and manufacturing information
Regulatory Elements Covered:
UDI, Declaration of Conformity, Classification rules, EMDN classification, SSP, Labelling and IFU requirements, Safety and performance documentation
Source Basis:
Regulation (EU) 2017/746 (IVDR)
Year:
2020
Region / City:
United Kingdom
Topic:
Pension Scheme, Coronavirus
Document Type:
Letter
Organization:
Spirit (Legacy) Pension Scheme Trustee
Author:
Iain Urquhart
Target Audience:
Pension Scheme Members
Period of Action:
Ongoing
Approval Date:
May 2020
Date of Changes:
None
Year:
2009
Region / City:
N/A
Topic:
iSCSI Boot Firmware Table (iBFT), ACPI 3.0b, Microsoft
Document Type:
Technical Specification
Organization / Institution:
Microsoft Corporation
Author:
Microsoft Corporation
Target Audience:
Developers, Firmware Engineers
Period of Validity:
N/A
Approval Date:
N/A
Amendment Date:
N/A
Year:
Not specified
Region / City:
Not specified
Subject:
Small Business Participation in Public Works Projects
Document Type:
Regulatory Text
Agency / Institution:
Department of General Services, Office of Small Business and DVBE Services
Author:
Not specified
Target Audience:
Contractors, Subcontractors, Small Business Enterprises (SBEs)
Period of Validity:
Not specified
Approval Date:
Not specified
Modification Date:
Not specified
Note:
Year
Topic:
Actuarial reports, Pension plans, Audits
Document type:
Guide
Target audience:
CPAs, Auditors
Year:
2021
Organization:
Microsoft Corporation
Document Type:
Technical specification / glossary
Subject:
Digital content protection, PlayReady, A/V content standards
Effective Date:
1st November 2021
Related Protocols:
AACS, AirPlay, COPP, Bluetooth Audio Profiles
Target Audience:
Developers and engineers implementing PlayReady compliance
Year:
2019
Region / City:
United States
Topic:
Pension Plan Actuarial Reporting
Document Type:
Form
Agency:
Department of the Treasury, Internal Revenue Service, Employee Benefits Security Administration, Pension Benefit Guaranty Corporation
Author:
Unknown
Target Audience:
Actuaries, Pension Plan Administrators, Legal and Financial Professionals
Period of Validity:
2019
Approval Date:
Not provided
Date of Amendments:
Not provided
Plan Type:
Single Employer Defined Benefit Plan
Plan Size:
More than 500 participants
Funding Target:
Available for participants and beneficiaries
Effective Interest Rate:
123.12%
Liquidity Shortfall:
Not provided
Year:
2020
Region / City:
United Kingdom
Topic:
Pension Scheme Management
Document Type:
Implementation Statement
Organization:
Compagnie Fruitiere UK Limited
Author:
Trustees of the Compagnie Fruitiere UK Limited Pension and Assurance Scheme
Target Audience:
Stakeholders, Pension Scheme Beneficiaries, Trustees
Period of Application:
1 January 2020 to 31 December 2020
Approval Date:
1 January 2020
Amendment Date:
1 January 2021
Year:
2014
Region / City:
Australia
Topic:
Cardiovascular Health
Document Type:
Supplementary Material
Author:
National Heart Foundation of Australia
Target Audience:
Healthcare Professionals, Cardiologists
Period of Action:
Not specified
Approval Date:
Not specified
Modification Date:
Not specified
Context:
A supplementary material detailing cardiovascular diagnoses and procedures eligible for cardiac rehabilitation, as defined by the National Heart Foundation of Australia.
Year:
2022
Region / City:
Colorado, United States
Topic:
Legal Evidence and Burden of Proof
Document Type:
Legal Instruction
Institution:
Colorado Judicial Department
Author:
Colorado Supreme Court
Target Audience:
Legal professionals, Judges, Lawyers
Period of validity:
Ongoing
Approval Date:
2022-01-01
Modification Date:
N/A
Year:
2026
Region / City:
Mombasa, Kenya
Document Type:
Tender Document
Organization:
Kenya Ports Authority
Contact Email:
[email protected]
Telephone:
+254 41 2112999 / 2113999
Tender Number:
KPA/046/2025-26/ICT
Subject:
Implementation and provisioning of secure software defined wide area network (SD-WAN)
Tendering Method:
Open National Competitive Bidding
Tender Security:
Kshs. 100,000
Validity Period of Tender Security:
240 days from tender opening
Submission Requirements:
One original, one copy, and one PDF on flash disk
Year:
2017
Region / City:
N/A
Topic:
BRAM Timing Diagram
Document Type:
VHDL Code
Institution / Organization:
N/A
Author:
Prof Jeff Falkinburg
Target Audience:
Engineers, Developers
Period of Validity:
N/A
Approval Date:
N/A
Date of Changes:
N/A