№ lp_1_2_39124
File format: docx
Character count: 47677
File size: 326 KB
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).
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The product description is provided for reference. Actual content and formatting may differ slightly.
Year:
2017
Region / City:
European Union
Theme:
Medical Devices
Document Type:
Checklist
Organization / Institution:
European Union
Author:
European Commission
Target Audience:
Medical device manufacturers
Period of Validity:
Ongoing
Approval Date:
[Insert Date]
Revision Date:
[Insert Date]
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:
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:
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:
Madrid, Spain
Topic:
IEEE 11073, HL7 Health Care Devices, PoCD WG
Document Type:
Meeting Agenda
Organization:
IEEE, HL7 International
Author:
ANSI - HL7 International
Target Audience:
IEEE EMBS 11073 SC, PoCD WG, HL7 Health Care Devices WG members
Effective Period:
May 8-11, 2017
Approval Date:
2017-04-27
Date of Last Revision:
2017-04-27
Year:
2023
Region / city:
EU
Topic:
Medical Device Safety
Document Type:
Checklist
Organization:
European Commission
Author:
European Commission
Target Audience:
Medical device manufacturers
Effective Period:
Ongoing
Approval Date:
2023
Revision Date:
Not specified
Year:
2024-2028
Region / city:
Australia
Topic:
ICT policies in schools
Document type:
Procedure/Guideline
Organ / institution:
Department of Education (DoE)
Author:
Department of Education
Target audience:
School employees, students, parents/guardians
Period of validity:
2024-2028
Approval date:
Not specified
Amendment date:
Not specified
Year:
2025
Region / city:
N/A
Theme:
Technical adaptation, mobile devices, network operators
Document type:
Industry Specification
Organization / institution:
GSMA
Author:
GSMA
Target audience:
Manufacturers, Mobile Network Operators (MNOs), device developers
Period of validity:
Indefinite
Approval date:
N/A
Modification date:
N/A
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:
Global
Topic:
Mobile device technical adaptation, customisation
Document type:
Industry specification
Organisation / institution:
GSMA
Author:
GSM Association
Target audience:
Manufacturers, MNOs, MVNOs
Period of validity:
Not specified
Approval date:
Not specified
Date of changes:
Not specified
Year:
2007
Region / city:
United States
Subject:
Encryption of unclassified data at rest
Document Type:
Policy Memorandum
Organization:
Department of Defense
Author:
Not specified
Target audience:
DoD personnel, contractors, and other related stakeholders
Period of validity:
Ongoing
Approval date:
July 3, 2007
Amendment date:
Not specified
Organization:
Asia-Pacific Telecommunity
Meeting:
The 31st Meeting of the APT Wireless Group (AWG-31)
Document number:
AWG-31/INP-85
Meeting date:
22–26 May 2023
Document date:
15 May 2023
Location:
Ha Noi, Socialist Republic of Viet Nam
Country case study:
Viet Nam
Document type:
Input document
Subject:
Monitoring and locating Rogue Base Station devices
Technology:
GSM, LTE
Target group:
National radio frequency authorities and regulators
Related bodies:
APT Wireless Group, Working Group Harmonization, Sub-Working Group on Spectrum Monitoring
Proposed outcome:
Development of a new APT Report
Period covered:
Since 2022
Technical focus:
Network monitoring, direction finding, spectrum analysis, MME log analysis
Regulatory context:
Radio frequency regulation enforcement
Year:
2022
Note:
Region / city
Topic:
Medical Devices, Safety, Compliance
Document Type:
Checklist
Organization / institution:
DFAR Department
Target Audience:
Manufacturers, Regulatory Bodies, Medical Device Industry
Effective Date:
31/10/2022
Review Due Date:
30/10/2025
Year:
2022
Region / city:
International
Topic:
Medical Devices
Document Type:
Technical Guidance
Organization:
International Medical Device Regulators Forum (IMDRF)
Author:
IMDRF PMD WG
Target Audience:
Regulatory Authorities, Conformity Assessment Bodies, Industry
Effective Period:
2022
Approval Date:
10 August 2022
Date of Changes:
N/A