№ lp_1_2_34526
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This document provides best practice guidance for manufacturers to ensure proper submission of technical documentation under the Medical Device Regulation (EU) 2017/745, focusing on Annex II and III, in order to facilitate the conformity assessment process.
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
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The product description is provided for reference. Actual content and formatting may differ slightly.
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:
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:
2020
Region / City:
Rochester, MN
Topic:
Cybersecurity of medical and research devices
Document type:
Vendor packet
Organization / Institution:
Mayo Clinic
Author:
Mayo Clinic
Target audience:
Vendors, healthcare technology management teams
Period of validity:
N/A
Approval date:
N/A
Date of amendments:
N/A
Year:
2025
Region / city:
EU
Topic:
Health Technology Assessment
Document Type:
Guidance
Organization / Institution:
HTA CG
Author:
European Commission
Target audience:
Professionals in Health Technology Assessment
Validity period:
From 28 NOVEMBER 2025
Approval date:
28 NOVEMBER 2025
Amendment date:
Not specified
Year:
2023
Region / City:
Global
Topic:
Internet of Things, IoT Device Testing
Document Type:
Industry Specification
Organization / Institution:
GSMA
Author:
GSMA
Target Audience:
Mobile Network Operators, IoT Service Providers, IoT Device Makers, IoT Device Application Developers, Communication Module Vendors, Radio Baseband Chipset Vendors
Validity Period:
N/A
Approval Date:
N/A
Amendment Date:
N/A
Description:
Industry specification document outlining test cases for IoT device compliance with GSMA IoT Device Connection Efficiency Guidelines, focusing on device behavior and network resource management.
Note:
Year
Document type:
Worksheet
Year:
2025
Region / city:
Global
Topic:
Internet of Things (IoT)
Document Type:
Industry Specification
Organization / Institution:
GSM Association
Author:
GSM Association
Target audience:
Mobile Network Operators, IoT Device Manufacturers, IoT Device Application Developers
Period of validity:
Ongoing
Approval date:
May 2025
Date of changes:
Not specified
Year:
2025
Region / City:
United Kingdom
Topic:
COVID-19 treatment, lateral flow device tests
Document Type:
Service Specification
Organization / Institution:
NHS England
Author:
NHS England
Target Audience:
Pharmacy contractors, healthcare professionals
Period of Validity:
Ongoing, from 6 November 2023
Date of Approval:
May 2025
Date of Changes:
01 May 2025
Note:
Year
Subject:
Emergency Use Treatment
Document Type:
Informed Consent Form
HDA Standard Pharmaceutical (Rx-only) Product and Medical Device Information Short Form Instructions
Note:
Year
Theme:
Pharmaceutical products, Medical devices
Document type:
Instructions, Form
Organization / Institution:
HDA
Target audience:
Distributors, Manufacturers, Supply chain professionals
Year:
XXXX
Region / City:
XXX
Theme:
Post-market Surveillance
Document Type:
Report
Organization:
XXX
Author:
XXX
Target Audience:
Regulatory Authorities, Healthcare Professionals
Period of Validity:
[start date] - [end date]
Approval Date:
YYYY-MM-DD
Revision Date:
YYYY-MM-DD
Year:
YYYY
Region / City:
[City/Region]
Topic:
Medical Device Safety and Performance Monitoring
Document Type:
PMCF Plan
Organization:
[Manufacturer Name]
Author:
[Author Name]
Target Audience:
Regulatory Authorities, Medical Device Manufacturers
Validity Period:
YYYY/MM/DD to YYYY/MM/DD
Approval Date:
DD/MM/YYYY
Revision Date:
XXXX
Date of Changes:
YYYY/MM/DD
Year:
2020
Region / city:
Not specified
Theme:
Defense, Technology Development
Document Type:
Statement of Objectives
Organization / Institution:
Not specified
Author:
Not specified
Target Audience:
Defense contractors, technology developers
Period of validity:
Not specified
Approval date:
Not specified
Modification date:
Not specified