№ lp_1_2_22183
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Notified bodies have collaborated to propose amendments to the MDR and IVDR review process, covering various topics such as early dialogue, digitalisation, and breakthrough designation.
Year:
2025
Region / city:
European Union
Topic:
Medical devices regulation, MDR, IVDR
Document type:
Proposal
Institution:
Notified Bodies
Author:
Team-NB and non-Team-NB members
Target audience:
Manufacturers, notified bodies, European Commission
Action period:
Ongoing review process
Approval date:
N/A
Date of amendments:
N/A
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Organization:
United Nations Development Programme
Document type:
Request for Proposal
RFP number:
36-21
Project title:
E-services and digital infrastructure as COVID-19 response measure
Country:
Montenegro
Issued on:
1 November 2021
Procurement category:
Services
Subject matter:
Development of communication campaign on digitalisation and electronic services
Issuing office:
UNDP Montenegro
Procurement method:
Competitive bidding
Applicable sections:
Instructions to Bidders, Evaluation Criteria, Terms of Reference, Bidding Forms
Relevant policies:
UNDP Programme and Operations Policies and Procedures
Target participants:
Bidders and service providers
Approval date:
1 November 2021
Approving officials:
Procurement Associate; Team Leader
Year:
2021
Date:
October 2021
Location:
Friedrichshafen, Germany
Company:
ENGEL AUSTRIA GmbH
Industry sector:
Plastics processing and injection moulding
Event:
Fakuma 2021
Document type:
Press release
Authorised representative:
Dr. Christoph Steger, CSO of the ENGEL Group
Key topics:
Sustainability, digitalisation, circular economy, hybrid and all-electric injection moulding machines
Products presented:
ENGEL e-speed 420, e-mac, e-motion TL
Technologies mentioned:
IML thin-wall technology, LSR processing, mono-material food packaging
Production sites:
Europe, North America, Asia (China and Korea)
Target audience:
Industry professionals, customers, journalists
Contact persons:
Ute Panzer; Susanne Zinckgraf
Headquarters:
Schwertberg, Austria
Website:
www.engelglobal.com
Year:
2024
Region / City:
European Union
Topic:
Regulatory simplification, digitalisation, reporting requirements
Document Type:
Explanatory memorandum
Institution:
European Commission
Author:
European Commission
Target Audience:
Policymakers, businesses, public authorities
Period of validity:
Ongoing
Approval date:
N/A
Date of changes:
N/A
Year:
2017
Regulation:
EU 2017/746
Annexes:
II, III
Device Types:
Class C, D, A, B
Intended Users:
Manufacturers, Regulatory Bodies
Document Type:
Technical Documentation Checklist
Applicable Legislation:
Regulation (EU) 2017/746 (IVDR)
Target Audience:
Manufacturers of medical devices
Purpose:
Compliance assessment for IVDR documentation
Date of Issue:
Not specified
Date of Last Revision:
Not specified
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:
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)
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:
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:
2019
Region / City:
India
Subject:
Telecommunications
Document Type:
List
Organization:
Ministry of Communications, Government of India
Author:
Not specified
Target Audience:
Telecom industry professionals, manufacturers
Effective Period:
1st October 2019 - 1st August 2024
Approval Date:
Not specified
Amendment Date:
Not specified
Note:
Context
Year:
2023
Region / city:
Europe
Topic:
Hybrid audits, quality management systems, MDR/IVDR
Document type:
Position paper
Organ / institution:
Team-NB
Author:
Team-NB
Target audience:
Notified bodies, auditors, manufacturers
Validity period:
Indefinite
Approval date:
May 16th, 2023
Date of amendments:
Not specified
Year:
2021
Note:
Region / city
Theme:
Medical Device Regulation
Document Type:
Proposal
Author:
Team-NB
Target Audience:
Competent Authorities, Notified Bodies
Approval Date:
06/10/2021
Year:
2013
Region / City:
Auckland
Theme:
Urban Planning, Future Development Zones
Document Type:
Urban Planning Document
Organization / Institution:
Auckland Council
Author:
Auckland Council
Target Audience:
Local Government, Urban Planners, Developers
Period of Validity:
Indefinite until further amendment
Approval Date:
30 September 2013
Date of Changes:
Not specified
Issuing body:
Notified Body PCBC
Country:
Poland
Legal basis:
Regulation of the Minister of Health of 17 February 2016; Directive 93/42/EEC; Directive 90/385/EEC
Subject:
Conformity assessment of medical devices and active implantable medical devices
Type of document:
Regulatory submission checklist
Scope:
Required statements, technical documentation, clinical and preclinical evaluation, risk management, and quality assurance system documentation
Applicable to:
Manufacturers and Authorised Representatives of medical devices
Related standards:
PN-EN ISO 14971; PN-EN ISO 10993-1; PN-EN 62366; EN ISO 14971; EN ISO 10993-1
Related regulations:
Commission Regulation (EU) No. 722/2012; Directive 2011/65/EU (RoHS2)
Referenced national acts:
Act on Medical Devices; Journal of Laws of the Republic of Poland 2016 item 211; Journal of Laws of the Republic of Poland 2011 No. 63 item 922
Content structure:
Statements and commitments; Technical documentation; Manufacturer Quality Assurance System Documentation
Year:
2023
Region / City:
EU
Theme:
Machinery Regulation, Certification
Document Type:
Press Release
Organization:
TÜV Rheinland
Author:
TÜV Rheinland Press Office
Target Audience:
Manufacturers, Industry Professionals
Effective Period:
From 20 January 2027
Approval Date:
Not specified
Modification Date:
Not specified