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This document is a template used for preliminary assessment reviews in the context of conformity assessment under the Medical Devices Regulation (EU) 2017/745, providing a structured approach for evaluating applications and conducting reviews by Designating Authorities.
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
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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:
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:
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:
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:
2012
Region / City:
Falls Church, VA
Topic:
TRICARE Dental Program, Data Exchange
Document Type:
Interface Control Document (ICD)
Organization / Institution:
DHSS Program Executive Office
Author:
Not specified
Target Audience:
DHSS Program Executive Office, TMA Contract Operations Office
Period of Validity:
Ongoing
Approval Date:
June 7, 2012
Date of Changes:
May 25, 2012
Year:
2004
Region / City:
Falls Church, VA
Topic:
Data Exchange, Health Care Provider Record
Document Type:
Technical Specification
Organization:
EI/DS Program Office
Author:
Mr. Phil Dederer, Mr. Steve Luhrman, Mr. Jeffrey Lopata, Mr. Allen Johnston
Target Audience:
Technical personnel, EI/DS Program Office members, TRICARE Management Activity-Aurora (TMA-Aurora) staff
Effective Period:
Not specified
Approval Date:
May 7, 2004
Revision Date:
Not specified
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:
2010
Region / City:
Falls Church, VA
Subject:
Data Exchange Interface
Document Type:
Interface Control Document
Organization:
DHSS Program Office
Author:
Paul Lindsey
Target Audience:
DHSS personnel, DHIMS personnel
Period of Validity:
Ongoing (until changes made)
Approval Date:
May 10, 2010
Modification Date:
November 23, 2009 (Mod 1)
Description:
This document defines the data exchange process for medical appointments and referrals between the Composite Health Care System (CHCS) and the Military Health System (MHS) Data Repository (MDR).
Document type:
Accountability log
Scope:
Clinical investigation site
Subject matter:
Investigational medical devices
Regulatory framework:
EU Regulation 2017/745 on Medical Devices (MDR)
Applicable date:
26 May 2021
Version date:
18 August 2021
Responsible organization:
Kliniska Studier Sverige
Responsible network:
National network for clinical investigations with medical devices within Clinical Studies Sweden
Geographical context:
Sweden
Intended setting:
Clinical investigation site(s)
Signatory role:
Principal Investigator
Source category:
Clinical research documentation
Year:
2020
Region / city:
East region
Topic:
Health care data management
Document Type:
Technical specification
Organization / Institution:
TRICARE
Author:
N. Bowling
Target audience:
TRICARE contractors, healthcare providers, data analysts
Period of validity:
Ongoing
Approval Date:
12/17/2020
Date of changes:
12/17/2020
Year:
2012
Region / City:
N/A
Subject:
Historical Data Management
Document Type:
Technical Specification
Organization / Institution:
N/A
Author:
D. Sexton
Target Audience:
Developers, Data Managers
Period of Validity:
N/A
Approval Date:
01/07/2012
Date of Changes:
N/A
Year:
2008
Region / City:
Falls Church, VA
Topic:
Case Management Data Exchange
Document Type:
Interface Control Document (ICD)
Organization:
DHSS Program Office
Author:
Paul Lindsey
Target Audience:
DHSS Program Office, BEA, and MHS personnel involved in data exchange
Period of Validity:
Ongoing
Approval Date:
August 18, 2008
Change Date:
N/A
Year:
2016
Region / City:
N/A
Topic:
Data Management / System Integration
Document Type:
Technical Specification
Organization / Institution:
N/A
Author:
T. Comer
Target Audience:
System developers, data administrators
Effective Period:
N/A
Approval Date:
09/27/2016
Revision Date:
N/A
Change History:
Initial versioning
Content:
This document specifies the structure, transmission, and transformation processes for the MTF Location File within the MHS Data Repository (MDR), focusing on linking workload and personnel data from CHCS to MHS Genesis system.