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The document is a compliance checklist for verifying that a medical device meets the General Safety and Performance Requirements outlined in EU Regulation 2017/746 for in vitro diagnostic devices.
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]
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The product description is provided for reference. Actual content and formatting may differ slightly.
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
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:
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:
Not specified
Region / City:
Not specified
Subject:
Laboratory biosafety
Document Type:
Manual
Organization / Institution:
Not specified
Author:
Not specified
Target Audience:
Laboratory personnel, safety officers
Period of Validity:
Not specified
Approval Date:
Not specified
Date of Changes:
Not specified
Year:
2023
Region / City:
Not specified
Topic:
Stakeholder Engagement and Information Disclosure
Document Type:
Guidance
Organization / Institution:
World Bank
Author:
Not specified
Target Audience:
Project developers, environmental and social experts, stakeholders involved in project preparation
Period of validity:
Not specified
Approval Date:
November 2023
Date of Changes:
Not specified
Year:
2017
Region / City:
Nevada
Topic:
Legal Document Requirements
Document Type:
Legal Notice
Organization / Institution:
County Recorder
Author:
Nevada Revised Statutes
Target Audience:
Individuals or entities submitting real property documents for recording
Period of Action:
Ongoing (from October 1, 2017)
Approval Date:
October 1, 2017
Date of Changes:
N/A
Year:
Not specified
Region / city:
Not specified
Topic:
Biblical studies, Life of Jesus
Document type:
Lesson plan / Bible study guide
Author:
Not specified
Target audience:
Students or Bible study participants
Scripture references:
John 19, Isaiah 53, Psalm 22, Psalm 34, Psalm 51, Psalm 69, Zechariah 12, Exodus 12, Leviticus 14, Numbers 19, Hebrews 9, Ephesians 1, 1 John 1
Purpose:
To understand the fulfillment of prophecies in the life and death of Jesus and explore the theological significance of his crucifixion and resurrection
Year:
2024
Region / City:
Vienna, Austria
Subject:
Environmental Product Declarations, Life Cycle Assessment
Document Type:
Product Category Rules (PCR)
Organization / Institution:
Bau EPD GmbH
Author:
Bau EPD GmbH
Target Audience:
Stakeholders in the environmental product declaration process, including manufacturers and environmental professionals
Period of Validity:
Not specified
Approval Date:
2024-01-24
Date of Changes:
2024-10-10
Year:
2024
Region / City:
Vienna, Austria
Theme:
Environmental Product Declarations (EPD) for Drywall Systems
Document Type:
Product Category Rules (PCR)
Organization / Institution:
Bau EPD GmbH
Author:
Bau EPD GmbH
Target Audience:
Manufacturers and stakeholders in the building industry
Validity Period:
Ongoing, updates as per EPD review and revisions
Approval Date:
2024-10-10
Date of Changes:
2024-10-10
Year:
2016
Region / City:
Not specified
Subject:
Video Surveillance Systems
Document Type:
Product Guide Specification
Standard:
CSI 3-Part Format, MasterFormat 2016
Manufacturer:
ZHEJIANG DAHUA VISION TECHNOLOGY CO., LTD.
Address:
No.1399, Binxing Road, Binjiang District, Hangzhou, P.R. China
Postal Code:
310053
Telephone:
+86-571-87688888 28933188
Email:
[email protected]
Website:
www.dahuasecurity.com
Warranty:
3 years for replacement and repair
Installer Experience Requirement:
Minimum 5 years
Manufacturer Experience Requirement:
Minimum 10 years
Supported Video Features:
Face detection, vehicle detection, perimeter protection, construction monitoring
Camera Resolution:
Up to 1920×1080
Power Supply:
12 VDC, 5 A ± 10%
Operating Temperature:
–20 °C to +55 °C
Protection Rating:
IP66, surge and lightning protection
Intelligence Type:
WizMind
Year:
2026
Region:
South East London, UK
Topic:
Prescribing and Shared Care Policy
Document Type:
Official Letter Template
Organization:
South East London Integrated Medicines Optimisation Committee (SEL IMOC)
Target Audience:
General Practitioners, Hospital Pharmacists
Applicable Period:
Current prescribing and shared care arrangements
Reference:
SEL Interface Policy, EL (95)5
URL:
http://www.selondonjointmedicinesformulary.nhs.uk/default.asp
Year:
2023
Region / city:
Vienna, Austria
Theme:
Environmental Product Declaration, Concrete and Concrete Elements
Document type:
Technical specification
Organization:
Bau EPD GmbH
Author:
Bau EPD GmbH
Target audience:
Environmental professionals, construction industry stakeholders
Validity period:
2023-05-30 onwards
Approval date:
2023-05-30
Date of revisions:
2018-06-13, 2019-07-06, 2020-11-05, 2021-01-12, 2021-04-07, 2021-08-27, 2021-11-27, 2023-01-27, 2023-05-30
Scope:
Concrete, Precast concrete parts
Relevant standards:
EN 15804, ISO 14025, ÖNORM EN 206, ÖNORM B 4710-1, ÖNORM EN 13369
Type of LCA calculation:
Specific for Concrete and Concrete Elements
LCA standards:
EN 15804+A2, EN 16757
Publishing institution:
Bau EPD GmbH
Declaration holder:
To be determined by Bau EPD GmbH
Accreditation mark:
ECO Platform
Description:
Technical document outlining the requirements for creating Environmental Product Declarations (EPDs) for concrete and concrete elements, based on ISO 14025 and EN 15804 standards.
Date:
2023-09-20
Region / City:
Austria, Vienna
Topic:
Environmental Product Declarations for Drywall Systems
Document Type:
Standards and Guidelines
Organization:
Bau EPD GmbH
Author:
Bau EPD GmbH
Target Audience:
Industry professionals, manufacturers, environmental consultants
Period of Validity:
Not specified
Date of Approval:
2023-09-20
Date of Changes:
2023-09-20
Year:
2023
Region / city:
Vienna, Austria
Theme:
Environmental Product Declarations, Construction Clay Products
Document Type:
Guidelines
Organ / Institution:
Bau EPD GmbH
Author:
Bau EPD GmbH
Target audience:
Companies and professionals in the construction industry
Validity Period:
Not specified
Approval Date:
2023-09-20
Date of Changes:
2023-09-20
Year:
2023
Document type:
Verification report and checklist
Subject:
Verification of LCA tools for Environmental Product Declarations
Standard:
EN 15804:2012+A2:2019+AC:2022
Reference standards:
CEN TR 16970; ECO Platform Guidelines
Programme operator:
Bau EPD GmbH
Organisation:
Austrian Bau-EPD Ltd. (Bau-EPD GmbH)
Related framework:
ECO Platform
Version history:
Version 0.1 draft; Version 1.0 approved
Date of approval:
2023-09-20
Scope:
Verification of LCA tools and related project reports
Validity period:
Maximum 5 years for LCA tools
Verification method:
ECO Platform checklist and M-Document 19a
Target application:
EPD creation using LCA tools
Checklist reference:
Procedure Verification LCA-Tool – Bau-EPD GmbH
Source type:
Conformity assessment and verification documentation