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emdn_eudamed_nomenclature_en.pdf.txt | Medical Devices January 2020
DG Health and Food Safety
Directorate Health systems, medical products and innovation
Unit Medical Devices
Page 1 of 1
The European Medical Device Nomenclature (EMDN)
The European Medical Device Nomenclature (EMDN) will be the nomenclature of use by
manufac... |
FAQ_MDR_180117_V1.0-1.pdf.txt | Page 1 of 13
CAMD Transition Sub Group
FAQ – MDR Transitional provisions
Disclaimer :
The information presented in this document is for the purpose of general information only and is not intended to represent legal advice to any individual
or entity. It reflects the outcome of discussions within the Transitio... |
ivd_mfr_stepbystep.pdf.txt | MEDICAL DEVICES CHANGE OF LEGISLATION
Internal market,
Industry,
Entrepreneurship
and SMEs1STEP INTENTION / ACTION
Pre-assessmentBrief management to ensure a clear understanding of the importance and
business implications of the IVDR
Consider organisational challenges: management awareness, staffing capability... |
scheer_o_015.pdf.txt | Final Version
Guidelines on the benefit -risk assessment of the presence of phthalates in certain
medical devices
Scientific Committee on Health, Environmental and Emerging Risks
SCHEER
GUIDELINES
on the benefit -risk assessment of the presence of
phthalates in certain medical devices
c... |
md_transitional-provisions-art-3-and-4_en.pdf.txt | Medical Device
Medical Device Coordination Group Document MDCG 2020 -2 rev.1
MDCG 2020 -2 rev. 1
Class I Transitional provisions under Article
120 (3 and 4) – (MDR)
March 2020
July 2020 rev.1
This doc... |
09 MDCG 2020-9 Regulatory Requirements for Ventilators and Reated Accessories.pdf.txt | Medical Device
Medical Device Coordination Group Document MDCG 2020-9
MDCG 2020-9
REGULATORY REQUIREMENTS
FOR VENTILATORS AND
RELATED ACCESSORIES
April 2020
This document has been endorsed by the Medical Device Coordination Group
(MDC... |
Mdr.Html.txt | L_2017117EN.01000101.xml
5.5.2017
EN
Official Journal of the European Union
L 117/1
REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 5 April 2017
on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regula... |
Guidance-on-Article-15-MDR-IVDR-Person-responsible-for-Regulatory-Compliance.pdf.txt | This document has been endorsed by the Medical Device Coordination Group (MDCG)
established by Article 103 of Regulation (EU) 2017/745. The MDCG is composed of
representatives of all Member States and it is chaired by a representative of the European
Commi ssion.
The document is not a European Commission document ... |
md_mfr_stepbystep.pdf.txt | Implementation Model for
Medical Devices
Regulation
Step by Step Guide
MEDICAL DEVICES CHANGE OF LEGISLATION
1STEP INTENTION / ACTION
Pre-assessmentBrief management to ensure a clear understanding of the importance and
business implications of the MDR
Consider organisational challenges: management awareness,
... |
MDCG 2019-8 v2 Implant guidance Card.pdf.txt | Medical Device
Medical Device Coordination Group Document MDCG 2019-8 v2
MDCG 2019-8 v2
Guidance document
Implant Card relating to the application
of Article 18 Regulation (EU) 2017/745
of the European Pa rliament and of the ... |
md_guidance-manufacturers_en.pdf.txt | Medical Device
Medical Device Coordination Group Document MDCG 2019 -15 rev1
MDCG 2019 -15 rev.1
GUIDANCE NOTES FOR MANUFACTURERS
OF CLASS I MEDICAL DEVICES
December 2019
July 2020 rev.1
This document has been endors... |
mdcg_2019_3_rev1_cecp_en.pdf.txt | Medical Devices
Medical Device Coordination Group Document MDCG 201 9-3 Rev.1
Page 1 of 4
MDCG 2019 -3 Rev. 1
Interpretation of Article 54(2)b
April 2020
This document has been endorsed by the Medical Device Coordination Group
(MDCG) established by Art... |
mdcg_2019_11_guidance_qualification_classification_software.pdf.txt | Medical Device
Medical Device Coordination Group Document MDCG 2019-11
MDCG 2019-11
Guidance on Qualification and Classification
of Software in Regulation (EU) 2017/745 – MDR
and Regulation (EU) 2017/746 – IVDR
October 2019
... |
md_mfr_factsheet.pdf.txt | Factsheet for
Manufacturers
of Medical Devices
What you need to know!MEDICAL DEVICES CHANGE OF LEGISLATION
This Factsheet is aimed at manufacturers of medical devices.
For a general overview of the impact of the In-Vitro Medical
Devices Regulation (IVDR) on manufacturers see the Factsheet
for manufacturers of... |
cnd_general_principles_en.pdf.txt | Medical Devices January 2020
DG Health and Food Safety
Directorate Health systems, medical products and innovation
Unit Medical Devices
Page 1 of 13
The CND Nomenclature
‘Classificazione Nazionale Dispositivi medici’
Table of Contents
1. Background and General Principles ............... |
emdn_eudamed_nomenclature_en.pdf.txt | Medical Devices January 2020
DG Health and Food Safety
Directorate Health systems, medical products and innovation
Unit Medical Devices
Page 1 of 1
The European Medical Device Nomenclature (EMDN)
The European Medical Device Nomenclature (EMDN) will be the nomenclature of use by
manufac... |
FAQ_MDR_180117_V1.0-1.pdf.txt | Page 1 of 13
CAMD Transition Sub Group
FAQ – MDR Transitional provisions
Disclaimer :
The information presented in this document is for the purpose of general information only and is not intended to represent legal advice to any individual
or entity. It reflects the outcome of discussions within the Transitio... |
ivd_mfr_stepbystep.pdf.txt | MEDICAL DEVICES CHANGE OF LEGISLATION
Internal market,
Industry,
Entrepreneurship
and SMEs1STEP INTENTION / ACTION
Pre-assessmentBrief management to ensure a clear understanding of the importance and
business implications of the IVDR
Consider organisational challenges: management awareness, staffing capability... |
scheer_o_015.pdf.txt | Final Version
Guidelines on the benefit -risk assessment of the presence of phthalates in certain
medical devices
Scientific Committee on Health, Environmental and Emerging Risks
SCHEER
GUIDELINES
on the benefit -risk assessment of the presence of
phthalates in certain medical devices
c... |
md_transitional-provisions-art-3-and-4_en.pdf.txt | Medical Device
Medical Device Coordination Group Document MDCG 2020 -2 rev.1
MDCG 2020 -2 rev. 1
Class I Transitional provisions under Article
120 (3 and 4) – (MDR)
March 2020
July 2020 rev.1
This doc... |
09 MDCG 2020-9 Regulatory Requirements for Ventilators and Reated Accessories.pdf.txt | Medical Device
Medical Device Coordination Group Document MDCG 2020-9
MDCG 2020-9
REGULATORY REQUIREMENTS
FOR VENTILATORS AND
RELATED ACCESSORIES
April 2020
This document has been endorsed by the Medical Device Coordination Group
(MDC... |
Mdr.Html.txt | L_2017117EN.01000101.xml
5.5.2017
EN
Official Journal of the European Union
L 117/1
REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 5 April 2017
on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regula... |
Guidance-on-Article-15-MDR-IVDR-Person-responsible-for-Regulatory-Compliance.pdf.txt | This document has been endorsed by the Medical Device Coordination Group (MDCG)
established by Article 103 of Regulation (EU) 2017/745. The MDCG is composed of
representatives of all Member States and it is chaired by a representative of the European
Commi ssion.
The document is not a European Commission document ... |
md_mfr_stepbystep.pdf.txt | Implementation Model for
Medical Devices
Regulation
Step by Step Guide
MEDICAL DEVICES CHANGE OF LEGISLATION
1STEP INTENTION / ACTION
Pre-assessmentBrief management to ensure a clear understanding of the importance and
business implications of the MDR
Consider organisational challenges: management awareness,
... |
MDCG 2019-8 v2 Implant guidance Card.pdf.txt | Medical Device
Medical Device Coordination Group Document MDCG 2019-8 v2
MDCG 2019-8 v2
Guidance document
Implant Card relating to the application
of Article 18 Regulation (EU) 2017/745
of the European Pa rliament and of the ... |
md_guidance-manufacturers_en.pdf.txt | Medical Device
Medical Device Coordination Group Document MDCG 2019 -15 rev1
MDCG 2019 -15 rev.1
GUIDANCE NOTES FOR MANUFACTURERS
OF CLASS I MEDICAL DEVICES
December 2019
July 2020 rev.1
This document has been endors... |
mdcg_2019_3_rev1_cecp_en.pdf.txt | Medical Devices
Medical Device Coordination Group Document MDCG 201 9-3 Rev.1
Page 1 of 4
MDCG 2019 -3 Rev. 1
Interpretation of Article 54(2)b
April 2020
This document has been endorsed by the Medical Device Coordination Group
(MDCG) established by Art... |
mdcg_2019_11_guidance_qualification_classification_software.pdf.txt | Medical Device
Medical Device Coordination Group Document MDCG 2019-11
MDCG 2019-11
Guidance on Qualification and Classification
of Software in Regulation (EU) 2017/745 – MDR
and Regulation (EU) 2017/746 – IVDR
October 2019
... |
md_mfr_factsheet.pdf.txt | Factsheet for
Manufacturers
of Medical Devices
What you need to know!MEDICAL DEVICES CHANGE OF LEGISLATION
This Factsheet is aimed at manufacturers of medical devices.
For a general overview of the impact of the In-Vitro Medical
Devices Regulation (IVDR) on manufacturers see the Factsheet
for manufacturers of... |
cnd_general_principles_en.pdf.txt | Medical Devices January 2020
DG Health and Food Safety
Directorate Health systems, medical products and innovation
Unit Medical Devices
Page 1 of 13
The CND Nomenclature
‘Classificazione Nazionale Dispositivi medici’
Table of Contents
1. Background and General Principles ............... |
mdcg_2019_2_gui_udi_dev_en.pdf.txt | Medical Devices
Medical Devices Coordination Group Document MDCG 201 9-2
Page 1 of 3
MDCG 201 9-2
Guidance on application of UDI rules to
device -part of products referred to in Article
1(8), 1(9) and 1(10) of Regulation 745/2017
February 2019
... |
mdcg_2018_4_udi_core_spp_en.pdf.txt | Medical Devices
Medical Devices Coordination Group Document MDCG 2018 -4
Page 1 of 3
MDCG 2018 -4
Annex: UDI database
Definitions/Descriptions and formats
of the UDI core elements for systems
or procedure packs
October 2018
This document has been endor... |
faq_udi_en.pdf.txt | Introduction to the new
UDI system and the
obligations of operators
The existing regulatory framework on medical
devices dates back to the 1990s and consists of
three Directives. Two new Regulations (Regulation
(EU) 745/2017 on medical devices and Regulation
(EU) 746/2017 on In Vitro diagnostic medical devices)... |
mdcg_2019_1_budi_rules_ie_en.pdf.txt | Medical Devices
Medical Devices Coordination Group Document MDCG 2019 -1
Page 1 of 2
MDCG 201 9-1
MDCG guiding principles for issuing entities
rules on Basic UDI -DI
January 2019
This document has been endorsed by the Medical Device Coordination G... |
MDCG 2018-1 v3 Guidance on basic UDI-DI and changes to UDI-DI.pdf.txt | 1
Medical Device
Medical Device Coordination Group Document MDCG 2018-1 v3
MDCG 2018-1 v3
Guidance on BASIC UDI-DI
and changes to UDI-DI
March 2020
This document has been endorsed b y the Medical Device Coordinat ion Group (MDCG) established... |
mdcg_2018_5_software_en.pdf.txt | Medical Devices
Medical Devices Coordination Group Document MDCG 2018 -5
Page 1 of 3
MDCG 2018 -5
UDI Assignment to Medical Device Software
October 2018
This document has been endorsed by the Medical Device Coordination Group
(MDCG) established by Article 1... |
mdcg_2018_7_languages_en.pdf.txt | Medical Devices
Medical Devices Coordination Group Document MDCG 2018 -7
Page 1 of 3
MDCG 2018 -7
Provisional considerations regarding language
issues associated with the UDI database
(Annex VI, Part A Section 2 and Part B of the
Medical Device Regulation (EU) 2017/745 (MDR)
and the In... |
mdcg_2018_6_art16_en.pdf.txt | Medical Devices
Medical Devices Coordination Group Document MDCG 2018 -6
Page 1 of 2
MDCG 2018 -6
Clarifications of UDI related responsibilities in
relation to Article 16 of the Medical Device
Regulation (EU) 2017/745 and the
In-Vitro Diagnostic Medical Device
Regulation (EU) 2017/746... |
mdcg_2018_2_nomenclature_en.pdf.txt | This document has been endorsed by the Medical Device Coordination Group (MDCG)
established by Article 103 of Regulation (EU) 2017/745. The MDCG is composed of
representatives of all Member States and it is chaired by a representative of the European
Commi ssion.
The document is not a European Commission documen... |
12 MDCG 2020-12 Guidance on transitional provisions for consultations of authorities on devices.pdf.txt | Medical Device
Medical Device Coordination Group Document MDCG 2020-12
Page 1 of 6
MDCG 2020-12
Guidance on transition al provisions for
consultations of authorities on devices
incorporating a substance which may be
considered a med... |
mdcg_2018_8_crf_transfer_en.pdf.txt | Medical Devices
Medical Devices Coordination Group Document MDCG 2018 -8
Page 1 of 2
MDCG 2018 -8
Guidance on c ontent of the certificates,
voluntary certificate transfers
November 2018
This document has been endorsed by the Medical Device Coord... |
mdcg_2019_14_MDR_codes.pdf.txt | 1
Medical Device
Medical Device Coordination Group Document MDCG 2019-14
MDCG 2019-14
Explanatory note on MDR codes
December 2019
This document has been endorsed by the Medical Device Coordination Group
(MDCG) established by Article 103 o... |
QA requirements for notified bodies V2 01102019.pdf.txt | Medical Devices
Medical Device Coordination Group Document MDCG 2019-6 v2
(01/10/2019)
Page 1 of 14
MDCG 2019-6 v2
Questions and answers:
Requirements relating to notified bodies
Version 2 - October 2019
This document has been endorsed by the Medical Device Coordination Gro... |
mdcg_2020_4_nb_audits_covid-19_en.pdf.txt | Medical Device
Medical Device Coordination Group Document MDCG 20 20-4
Page 1 of 6
MDCG 20 20-4
Guidance on temporary extraordinary
measures related to medical device Notified
Body audits during COVID -19 quarantine orders
and travel restrictions
April 2020
... |
Guidance on significant changes & annexes.pdf.txt | 1
Medical Device
Medical Device Coordination Group Document MDCG 2020 - 3
MDCG 2020 -3
Guidance on significant changes regarding
the transitional provision under Article 120
of the MDR with regard to devices covered
by certificates according to MDD or AIMDD ... |
md_application-transitional-provisions-certificates_en.pdf.txt | Medical Device
Medical Device Coordination Group Document MDCG 201 9-10 rev.1
Page 1 of 2
MDCG 201 9-10 rev. 1
Application of transitional provisions concerning
validity of certificates issued in accordance to
Directives 90/385/EEC and 93/42/EEC
October 2019 ... |
md_2020-14-guidance-mdsap_en.pdf.txt | 1
Medical Devices
Medical Device Coordination Group Document MDCG 2020-14
MDCG 2020-14
Guidance for notified bodies on the use of
MDSAP audit reports in the context of
surveillance audits carried out under the
Medical Devices Regulation (MDR)/ In Vitro
Diag... |
mdcg_2019_13_sampling_MDR_IVDR.pdf.txt | 1
Medical Device
Medical Device Coordination Group Document MDCG 2019 -13
MDCG 2019 -13
Guidance on sampling of MDR Class IIa / Class IIb
and IVDR Class B / Class C devices
for the assessment of the technical documentation
... |
11 MDCG 2020-11 Guidance on the renewal of designation and monitoring of notified bodies under Directives 90385EEC and 9342EEC.pdf.txt | Medical Device
Medical Device Coordination Group Document MDCG 2020-11
1
MDCG 2020-11
Guidance on the renewal of designation and
monitoring of notified bodies under Directives
90/385/EEC and 93/42/EEC to be performed in
accordance with Commission Impleme... |
mdcg_2019_5_legacy_devices_registration_eudamed_en.pdf.txt | Medical Device
Medical Device Coordination Group Document MDCG 201 9-5
Page 1 of 4
MDCG 201 9-5
Registration of legacy devices in EUDAMED
April 2019
This document has been endorsed by the Medical Device Coordination Group
(MDCG) established by Article... |
mdcg_2019_4_devices_registration_eudamed_en.pdf.txt | Medical Device
Medical Device Coordination Group Document MDCG 201 9-4
Page 1 of 2
MDCG 201 9-4
Timelines for registration of device
data elements in EUDAMED
April 2019
This document has been endorsed by the Medical Device Coordination Group
(MDCG... |
2020-15-position-paper-actor-registration-module_en.pdf.txt | Medical Devices
Medical Device Coordination Group Document MDCG 2020-15
MDCG 2020-15
MDCG Position Paper on the use of the
EUDAMED actor registration module and
of the Single Registration Number (SRN)
in the Member States
August 2020
T... |
05 MDCG 2020-5 Guidance on Clinical Evaluation - Equivalence.pdf.txt | Medical Device
Medical Device Coordination Group Document MDCG 2020-5
MDCG 2020-5
Clinical Evaluation - Equivalence
A guide for manufacturers and notified bodies
April 2020
This document has been endorsed by the Medical Device Coordination Group (MDCG)
establi... |
10-1 MDCG 2020-10-1 Guidance on safety reporting in clinical investigations.pdf.txt | Page 1 of 16 1
MDCG 2020-10/1
Safety reporting in clinical investigations
of medical devices under the
Regulation (EU) 2017/745
May 2020
This document has been endorsed by the Medical Device Coordination Group (MDCG) established by Article 103 of Regulation (EU)
2017/745. The MDCG is... |
08 MDCG 2020-8 Guidance on PMCF Evaluation Report Template.pdf.txt | Medical Device
Medical Device Coordination Group Document MDCG 2020-8
1
MDCG 2020-8
Post-market clinical follow-up (PMCF) Evaluation Report Template
A guide for manufacturers and notified bodies
April 2020
This document has been endorsed by the Medical D... |
07 MDCG 2020-7 Guidance on PMCF Plan Template.pdf.txt | Medical Device
Medical Device Coordination Group Document MDCG 2020-7
1
MDCG 2020-7
Post-market clinical follow-up (PMCF) Plan Template
A guide for manufacturers and notified bodies
April 2020
This document has been endorsed by the Medical Device Coordin... |
06 MDCG 2020-6 Guidance on Sufficient Clinical Evidence for Legacy Devices.pdf.txt | Medical Device
Medical Device Coordination Group Document MDCG 2020-6
MDCG 2020-6
Regulation (EU) 2017/745: Clinical evidence needed for
medical devices previously CE marked under
Directives 93/42/EEC or 90/385/EEC
A guide for manufacturers and notifie... |
mdcg_clinical_evaluationtemplate_en.pdf.txt | Medical Devices
Medical Devices Coordination Group Document MDCG 2020-13
0
MDCG 2020-13
Clinical evaluation assessment report template
July 2020
This document has been endorsed by the Medical Device Coordination Group (MDCG) estab... |
MDCG 2020-1.pdf.txt | Medical Device
Medical Device Coordination Group Document MDCG 2020-1
MDCG 2020-1
Guidance on Clinical Evaluation (MDR)
/ Performance Evaluation (IVDR) of
Medical Device Software
March 2020
This document has been endorsed by ... |
mdcg_2019_9_sscp_en.pdf.txt | Medical Device
Medical Device Coordination Group Document MDCG 2019-9
1(24)
MDCG 2019-9
Summary of safety and clinical performance
A guide for manufacturers and notified bodies
August 2019
This document has been endorsed by the Medical Device Coordina... |
emdn_eudamed_nomenclature_en.pdf.txt | Medical Devices January 2020
DG Health and Food Safety
Directorate Health systems, medical products and innovation
Unit Medical Devices
Page 1 of 1
The European Medical Device Nomenclature (EMDN)
The European Medical Device Nomenclature (EMDN) will be the nomenclature of use by
manufac... |
FAQ_MDR_180117_V1.0-1.pdf.txt | Page 1 of 13
CAMD Transition Sub Group
FAQ – MDR Transitional provisions
Disclaimer :
The information presented in this document is for the purpose of general information only and is not intended to represent legal advice to any individual
or entity. It reflects the outcome of discussions within the Transitio... |
ivd_mfr_stepbystep.pdf.txt | MEDICAL DEVICES CHANGE OF LEGISLATION
Internal market,
Industry,
Entrepreneurship
and SMEs1STEP INTENTION / ACTION
Pre-assessmentBrief management to ensure a clear understanding of the importance and
business implications of the IVDR
Consider organisational challenges: management awareness, staffing capability... |
scheer_o_015.pdf.txt | Final Version
Guidelines on the benefit -risk assessment of the presence of phthalates in certain
medical devices
Scientific Committee on Health, Environmental and Emerging Risks
SCHEER
GUIDELINES
on the benefit -risk assessment of the presence of
phthalates in certain medical devices
c... |
md_transitional-provisions-art-3-and-4_en.pdf.txt | Medical Device
Medical Device Coordination Group Document MDCG 2020 -2 rev.1
MDCG 2020 -2 rev. 1
Class I Transitional provisions under Article
120 (3 and 4) – (MDR)
March 2020
July 2020 rev.1
This doc... |
09 MDCG 2020-9 Regulatory Requirements for Ventilators and Reated Accessories.pdf.txt | Medical Device
Medical Device Coordination Group Document MDCG 2020-9
MDCG 2020-9
REGULATORY REQUIREMENTS
FOR VENTILATORS AND
RELATED ACCESSORIES
April 2020
This document has been endorsed by the Medical Device Coordination Group
(MDC... |
Mdr.Html.txt | L_2017117EN.01000101.xml
5.5.2017
EN
Official Journal of the European Union
L 117/1
REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 5 April 2017
on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regula... |
Guidance-on-Article-15-MDR-IVDR-Person-responsible-for-Regulatory-Compliance.pdf.txt | This document has been endorsed by the Medical Device Coordination Group (MDCG)
established by Article 103 of Regulation (EU) 2017/745. The MDCG is composed of
representatives of all Member States and it is chaired by a representative of the European
Commi ssion.
The document is not a European Commission document ... |
md_mfr_stepbystep.pdf.txt | Implementation Model for
Medical Devices
Regulation
Step by Step Guide
MEDICAL DEVICES CHANGE OF LEGISLATION
1STEP INTENTION / ACTION
Pre-assessmentBrief management to ensure a clear understanding of the importance and
business implications of the MDR
Consider organisational challenges: management awareness,
... |
MDCG 2019-8 v2 Implant guidance Card.pdf.txt | Medical Device
Medical Device Coordination Group Document MDCG 2019-8 v2
MDCG 2019-8 v2
Guidance document
Implant Card relating to the application
of Article 18 Regulation (EU) 2017/745
of the European Pa rliament and of the ... |
md_guidance-manufacturers_en.pdf.txt | Medical Device
Medical Device Coordination Group Document MDCG 2019 -15 rev1
MDCG 2019 -15 rev.1
GUIDANCE NOTES FOR MANUFACTURERS
OF CLASS I MEDICAL DEVICES
December 2019
July 2020 rev.1
This document has been endors... |
mdcg_2019_3_rev1_cecp_en.pdf.txt | Medical Devices
Medical Device Coordination Group Document MDCG 201 9-3 Rev.1
Page 1 of 4
MDCG 2019 -3 Rev. 1
Interpretation of Article 54(2)b
April 2020
This document has been endorsed by the Medical Device Coordination Group
(MDCG) established by Art... |
mdcg_2019_11_guidance_qualification_classification_software.pdf.txt | Medical Device
Medical Device Coordination Group Document MDCG 2019-11
MDCG 2019-11
Guidance on Qualification and Classification
of Software in Regulation (EU) 2017/745 – MDR
and Regulation (EU) 2017/746 – IVDR
October 2019
... |
md_mfr_factsheet.pdf.txt | Factsheet for
Manufacturers
of Medical Devices
What you need to know!MEDICAL DEVICES CHANGE OF LEGISLATION
This Factsheet is aimed at manufacturers of medical devices.
For a general overview of the impact of the In-Vitro Medical
Devices Regulation (IVDR) on manufacturers see the Factsheet
for manufacturers of... |
cnd_general_principles_en.pdf.txt | Medical Devices January 2020
DG Health and Food Safety
Directorate Health systems, medical products and innovation
Unit Medical Devices
Page 1 of 13
The CND Nomenclature
‘Classificazione Nazionale Dispositivi medici’
Table of Contents
1. Background and General Principles ............... |
mdcg_2019_2_gui_udi_dev_en.pdf.txt | Medical Devices
Medical Devices Coordination Group Document MDCG 201 9-2
Page 1 of 3
MDCG 201 9-2
Guidance on application of UDI rules to
device -part of products referred to in Article
1(8), 1(9) and 1(10) of Regulation 745/2017
February 2019
... |
mdcg_2018_4_udi_core_spp_en.pdf.txt | Medical Devices
Medical Devices Coordination Group Document MDCG 2018 -4
Page 1 of 3
MDCG 2018 -4
Annex: UDI database
Definitions/Descriptions and formats
of the UDI core elements for systems
or procedure packs
October 2018
This document has been endor... |
faq_udi_en.pdf.txt | Introduction to the new
UDI system and the
obligations of operators
The existing regulatory framework on medical
devices dates back to the 1990s and consists of
three Directives. Two new Regulations (Regulation
(EU) 745/2017 on medical devices and Regulation
(EU) 746/2017 on In Vitro diagnostic medical devices)... |
mdcg_2019_1_budi_rules_ie_en.pdf.txt | Medical Devices
Medical Devices Coordination Group Document MDCG 2019 -1
Page 1 of 2
MDCG 201 9-1
MDCG guiding principles for issuing entities
rules on Basic UDI -DI
January 2019
This document has been endorsed by the Medical Device Coordination G... |
MDCG 2018-1 v3 Guidance on basic UDI-DI and changes to UDI-DI.pdf.txt | 1
Medical Device
Medical Device Coordination Group Document MDCG 2018-1 v3
MDCG 2018-1 v3
Guidance on BASIC UDI-DI
and changes to UDI-DI
March 2020
This document has been endorsed b y the Medical Device Coordinat ion Group (MDCG) established... |
mdcg_2018_5_software_en.pdf.txt | Medical Devices
Medical Devices Coordination Group Document MDCG 2018 -5
Page 1 of 3
MDCG 2018 -5
UDI Assignment to Medical Device Software
October 2018
This document has been endorsed by the Medical Device Coordination Group
(MDCG) established by Article 1... |
mdcg_2018_7_languages_en.pdf.txt | Medical Devices
Medical Devices Coordination Group Document MDCG 2018 -7
Page 1 of 3
MDCG 2018 -7
Provisional considerations regarding language
issues associated with the UDI database
(Annex VI, Part A Section 2 and Part B of the
Medical Device Regulation (EU) 2017/745 (MDR)
and the In... |
mdcg_2018_6_art16_en.pdf.txt | Medical Devices
Medical Devices Coordination Group Document MDCG 2018 -6
Page 1 of 2
MDCG 2018 -6
Clarifications of UDI related responsibilities in
relation to Article 16 of the Medical Device
Regulation (EU) 2017/745 and the
In-Vitro Diagnostic Medical Device
Regulation (EU) 2017/746... |
mdcg_2018_2_nomenclature_en.pdf.txt | This document has been endorsed by the Medical Device Coordination Group (MDCG)
established by Article 103 of Regulation (EU) 2017/745. The MDCG is composed of
representatives of all Member States and it is chaired by a representative of the European
Commi ssion.
The document is not a European Commission documen... |
12 MDCG 2020-12 Guidance on transitional provisions for consultations of authorities on devices.pdf.txt | Medical Device
Medical Device Coordination Group Document MDCG 2020-12
Page 1 of 6
MDCG 2020-12
Guidance on transition al provisions for
consultations of authorities on devices
incorporating a substance which may be
considered a med... |
mdcg_2018_8_crf_transfer_en.pdf.txt | Medical Devices
Medical Devices Coordination Group Document MDCG 2018 -8
Page 1 of 2
MDCG 2018 -8
Guidance on c ontent of the certificates,
voluntary certificate transfers
November 2018
This document has been endorsed by the Medical Device Coord... |
mdcg_2019_14_MDR_codes.pdf.txt | 1
Medical Device
Medical Device Coordination Group Document MDCG 2019-14
MDCG 2019-14
Explanatory note on MDR codes
December 2019
This document has been endorsed by the Medical Device Coordination Group
(MDCG) established by Article 103 o... |
QA requirements for notified bodies V2 01102019.pdf.txt | Medical Devices
Medical Device Coordination Group Document MDCG 2019-6 v2
(01/10/2019)
Page 1 of 14
MDCG 2019-6 v2
Questions and answers:
Requirements relating to notified bodies
Version 2 - October 2019
This document has been endorsed by the Medical Device Coordination Gro... |
mdcg_2020_4_nb_audits_covid-19_en.pdf.txt | Medical Device
Medical Device Coordination Group Document MDCG 20 20-4
Page 1 of 6
MDCG 20 20-4
Guidance on temporary extraordinary
measures related to medical device Notified
Body audits during COVID -19 quarantine orders
and travel restrictions
April 2020
... |
Guidance on significant changes & annexes.pdf.txt | 1
Medical Device
Medical Device Coordination Group Document MDCG 2020 - 3
MDCG 2020 -3
Guidance on significant changes regarding
the transitional provision under Article 120
of the MDR with regard to devices covered
by certificates according to MDD or AIMDD ... |
md_application-transitional-provisions-certificates_en.pdf.txt | Medical Device
Medical Device Coordination Group Document MDCG 201 9-10 rev.1
Page 1 of 2
MDCG 201 9-10 rev. 1
Application of transitional provisions concerning
validity of certificates issued in accordance to
Directives 90/385/EEC and 93/42/EEC
October 2019 ... |
md_2020-14-guidance-mdsap_en.pdf.txt | 1
Medical Devices
Medical Device Coordination Group Document MDCG 2020-14
MDCG 2020-14
Guidance for notified bodies on the use of
MDSAP audit reports in the context of
surveillance audits carried out under the
Medical Devices Regulation (MDR)/ In Vitro
Diag... |
mdcg_2019_13_sampling_MDR_IVDR.pdf.txt | 1
Medical Device
Medical Device Coordination Group Document MDCG 2019 -13
MDCG 2019 -13
Guidance on sampling of MDR Class IIa / Class IIb
and IVDR Class B / Class C devices
for the assessment of the technical documentation
... |
11 MDCG 2020-11 Guidance on the renewal of designation and monitoring of notified bodies under Directives 90385EEC and 9342EEC.pdf.txt | Medical Device
Medical Device Coordination Group Document MDCG 2020-11
1
MDCG 2020-11
Guidance on the renewal of designation and
monitoring of notified bodies under Directives
90/385/EEC and 93/42/EEC to be performed in
accordance with Commission Impleme... |
mdcg_2019_5_legacy_devices_registration_eudamed_en.pdf.txt | Medical Device
Medical Device Coordination Group Document MDCG 201 9-5
Page 1 of 4
MDCG 201 9-5
Registration of legacy devices in EUDAMED
April 2019
This document has been endorsed by the Medical Device Coordination Group
(MDCG) established by Article... |
mdcg_2019_4_devices_registration_eudamed_en.pdf.txt | Medical Device
Medical Device Coordination Group Document MDCG 201 9-4
Page 1 of 2
MDCG 201 9-4
Timelines for registration of device
data elements in EUDAMED
April 2019
This document has been endorsed by the Medical Device Coordination Group
(MDCG... |
2020-15-position-paper-actor-registration-module_en.pdf.txt | Medical Devices
Medical Device Coordination Group Document MDCG 2020-15
MDCG 2020-15
MDCG Position Paper on the use of the
EUDAMED actor registration module and
of the Single Registration Number (SRN)
in the Member States
August 2020
T... |
05 MDCG 2020-5 Guidance on Clinical Evaluation - Equivalence.pdf.txt | Medical Device
Medical Device Coordination Group Document MDCG 2020-5
MDCG 2020-5
Clinical Evaluation - Equivalence
A guide for manufacturers and notified bodies
April 2020
This document has been endorsed by the Medical Device Coordination Group (MDCG)
establi... |
10-1 MDCG 2020-10-1 Guidance on safety reporting in clinical investigations.pdf.txt | Page 1 of 16 1
MDCG 2020-10/1
Safety reporting in clinical investigations
of medical devices under the
Regulation (EU) 2017/745
May 2020
This document has been endorsed by the Medical Device Coordination Group (MDCG) established by Article 103 of Regulation (EU)
2017/745. The MDCG is... |
08 MDCG 2020-8 Guidance on PMCF Evaluation Report Template.pdf.txt | Medical Device
Medical Device Coordination Group Document MDCG 2020-8
1
MDCG 2020-8
Post-market clinical follow-up (PMCF) Evaluation Report Template
A guide for manufacturers and notified bodies
April 2020
This document has been endorsed by the Medical D... |
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