№ lp_2_3_45164
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This document serves as a confirmation letter from a Notified Body regarding the formal application, written agreement, and surveillance responsibilities under the EU IVDR regulation for medical devices and in vitro diagnostic devices.
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
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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:
2025
Region / City:
European Union
Topic:
Medical Devices
Document Type:
Application Form
Authoring Organization:
Medical Device Coordination Group (MDCG)
Target Audience:
Conformity assessment bodies
Period of Validity:
Ongoing
Approval Date:
January 2025
Amendment Date:
N/A
Year:
2017
Region / City:
European Union
Theme:
Medical Device Regulation
Document Type:
Regulatory Document
Organization / Institution:
Medical Device Coordination Group (MDCG)
Target Audience:
National Authorities, Notified Bodies, Conformity Assessment Bodies
Period of Validity:
Not specified
Approval Date:
Not specified
Amendment Date:
Not specified
Year:
2017
Region / City:
N/A
Theme:
Medical Device Regulation
Document Type:
Fee List
Organization / Institution:
Notified Body XXXX
Target Audience:
Manufacturers of medical devices
Period of Validity:
N/A
Approval Date:
N/A
Date of Changes:
N/A
Year:
2025
Region / City:
European Union
Subject:
Medical Devices
Document Type:
Template
Organization / Institution:
Medical Device Coordination Group (MDCG)
Author:
MDCG
Target Audience:
Conformity Assessment Bodies (CABs), Designating Authorities (DAs), Reviewers
Validity Period:
Not specified
Approval Date:
January 2025
Amendment Date:
Not specified
Year:
2024
Region / City:
European Union
Subject:
Medical device regulation, re-assessment process
Document Type:
Template
Organization / Institution:
Medical Device Coordination Group (MDCG)
Author:
MDCG
Target Audience:
Notified bodies, Designating Authorities, European Commission
Period of Validity:
Not specified
Approval Date:
May 2024
Amendment Date:
Not specified
Year:
2022
Region / City:
European Union
Topic:
Medical Device Regulation
Document Type:
Best Practice Guidance
Organization:
Team-NB
Author:
Team-NB
Target Audience:
Manufacturers, Notified Bodies
Period of Validity:
Indefinite (subject to revision)
Approval Date:
5/10/2022
Next Revision Date:
5/10/2024
Year:
2022
Region / City:
EU
Topic:
Medical Device Regulation
Document Type:
Technical Documentation
Organization / Institution:
European Union
Author:
Guillaume Valenzuela
Target Audience:
Medical Device Manufacturers
Period of Validity:
Not specified
Approval Date:
19JAN2022
Date of Changes:
Not specified
Context description:
A technical document outlining the General Safety and Performance Requirements (GSPR) checklist for medical devices in compliance with the EU Medical Devices Regulation 2017/745 (MDR).
Year:
Not specified
Region / Countries:
EU/EEA/UK (Northern Ireland), Turkey and Switzerland; countries outside EU/EEA/UK
Regulatory Framework:
Regulation (EU) 2017/745 (MDR)
Document Type:
Clinical investigation application form
Subject:
Clinical investigation of medical devices
Sponsor:
To be completed
Legal Representative:
To be completed
Coordinating Investigator:
To be completed
Investigational Device:
Medical device (CE marked or non-CE marked)
Comparator:
Medical device (if applicable)
Submission Type:
First submission, national submission, or resubmission
Clinical Investigation Plan:
CIP Code, version and date
Development Stage:
Pilot, pivotal or post-market stage
Design:
Exploratory, confirmatory, observational, first-in-human or not first-in-human
Methodology:
Controlled, randomised, double blind, open, parallel, cross-sectional or case control
Population:
Defined by medical condition, therapeutic area, gender, age range, inclusion and exclusion criteria
Endpoints:
Primary, secondary and other endpoints
Participating Countries:
Listed EU and non-EU countries
Ethics Committee:
Information required
National Competent Authority:
Decision status and date (if applicable)
Status of Clinical Investigation:
To be specified
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:
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:
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)