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Regulatory guidance document setting out notified body expectations for the content, structure, and submission of technical documentation for in vitro diagnostic medical devices under Regulation (EU) 2017/746.
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
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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
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)
Information on the entry into force of amended annexes A and B to the Minamata Convention on Mercury
Year:
2025
Region / City:
Geneva
Subject:
Mercury pollution, international environmental agreements
Document Type:
Information note
Organization:
United Nations Environment Programme (UNEP)
Author:
UNEP Secretariat
Target Audience:
Parties to the Minamata Convention, stakeholders in international environmental policy
Effective Period:
2025–2027
Approval Date:
25 April 2024
Amendment Date:
19 May 2025
Year:
2017
Region / City:
United Kingdom
Topic:
Housing Ombudsman Scheme, Dispute Resolution, Governance
Document Type:
Framework Document
Organization / Institution:
Department for Communities and Local Government (DCLG)
Author:
Housing Ombudsman
Target Audience:
Government officials, social landlords, housing authorities, housing professionals
Period of Validity:
2013-ongoing
Approval Date:
December 2017
Amendment Date:
June 2021
Context:
A government framework document outlining the roles, responsibilities, and accountability of the Housing Ombudsman (THO) in relation to housing complaints and dispute resolution within the UK housing sector.
Year:
2021
Region / City:
Great Britain
Topic:
Biocidal Products Regulation, Biocidal Products
Document Type:
Consultation Document
Organization:
Health and Safety Executive (HSE)
Author:
Health and Safety Executive (HSE)
Target Audience:
Businesses, stakeholders in the biocidal products industry
Period of Application:
From Autumn 2023
Approval Date:
Not specified
Date of Changes:
Not specified
Year:
2013
Region / city:
Geneva
Topic:
Laboratory quality management
Document type:
Standard Operating Procedure
Organization / institution:
Laboratory quality department
Author:
Not specified
Target audience:
Laboratory staff
Period of validity:
Not specified
Approval date:
Not specified
Date of changes:
Not specified
Year:
2016
Region / City:
Not specified
Topic:
Open Geospatial Consortium Best Practices
Document Type:
OGC® Best Practice
Organization:
Open Geospatial Consortium (OGC)
Author:
Carl Reed
Target Audience:
Professionals and organizations involved in geospatial data
Period of Validity:
Not specified
Approval Date:
2016-04-04
Publication Date:
Not specified
Modification Date:
Not specified
Note:
Year
Note:
Year
Year:
2025
Note:
Region / City
Theme:
Human Medicines
Document Type:
Product Information
Authority / Organization:
European Medicines Agency
Target Audience:
Healthcare professionals, regulatory authorities
Approval Date:
14 April 2025
Year:
2023
Region / City:
Addis Ababa
Theme:
Monitoring and Evaluation
Document Type:
Operational Annex
Author:
Ministry of Agriculture
Target Audience:
Government agencies, implementing partners
Period of Effectiveness:
PSNP5
Approval Date:
Not specified
Date of Changes:
Not specified
Year:
2022
Region / city:
Global
Theme:
United Nations Joint Programmes
Document Type:
Guidance Note
Organization / Institution:
United Nations
Author:
United Nations Development Coordination Office (DCO)
Target Audience:
UN organizations, non-UN partners, government bodies
Period of Validity:
Indefinite
Approval Date:
October 2022
Date of Changes:
Not specified
Year:
2012
Region / City:
Islamabad, Pakistan
Topic:
Good Manufacturing Practices (GMP) for Sterile Products
Document Type:
Guideline
Organization / Institution:
Drug Regulatory Authority of Pakistan
Author:
Drug Regulatory Authority of Pakistan
Target Audience:
Manufacturers, Inspectors
Effective Date:
Not specified
Date of Approval:
Not specified
Date of Changes:
Not specified
Year:
2022
Region / city:
Global
Topic:
Joint Programmes, UN Cooperation
Document Type:
Guidance Note
Organization / Institution:
United Nations
Author:
UN Development Coordination Office
Target Audience:
UN Organizations, Partners
Period of validity:
October 2022 onwards
Approval Date:
October 2022
Date of Changes:
N/A