Slide background
Slide background

Raccolta Linee guida MEDDEV Dispositivi medici

ID 2047 | | Visite: 16960 | Guide Nuovo ApproccioPermalink: https://www.certifico.com/id/2047



Raccolta Linee guida MEDDEV Dispositivi medici

Update October 2018 (10.10.2018)

Allegate tutte le Guide ufficiali sui i Dispositivi medici in accordo con la Direttiva 93/42/CEE e il nuovo Regolamento (UE) 2017/745

Direttiva 93/42/CEE del Consiglio del 14 giugno 1993 concernente i dispositivi medici(*)

(*) Direttiva abrogata e sostituita dal Regolamento (UE) 2017/745 | Si applica dal 20 Maggio 2020

New regulations

Guidance documents to assist stakeholders in implementing the Medical Devices Regulations.

1. MDCG Documents

MDCG endorsed documents

Reference

Title

Publication date

MDCG 2018-1

Draft guidance on basic UDI-DI and changes to UDI-DI

March 2018

MDCG 2018-2

Future EU medical device nomenclature – Description of requirements

March 2018

MDCG 2018-3

Guidance on UDI for systems and procedure packs

October 2018

MDCG 2018-4

Annex: UDI database Definitions/Descriptions and formats of the UDI core elements for systems or procedure packs October 2018
MDCG 2018-5

UDI Assignment to Medical Device Software

October 2018
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

October 2018
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-Vitro Diagnostic Medical Device Regulation (EU) 2017/746 (IVDR))

October 2018

 

Designation of notified bodies under the new Regulations on medical devices

Notified BODIES Designation of notified bodies under the new Regulations on medical devices
  1. Best practice guidance on designation and notification of conformity assessment bodies (NBOG BPG 2017-1)
  2. Best practice guidance on the information required for conformity assessment bodies' personnel involved in conformity assessment activities (NBOG BPG 2017-2)
  3. Application form to be submitted by a conformity assessment body when applying for designation as notified body under the medical devices Regulation (MDR) (NBOG F 2017-1)
  4. Application form to be submitted by a conformity assessment body when applying for designation as notified body under the in vitro diagnostic devices Regulation (IVDR) (NBOG F 2017-2)
  5. Applied-for scope of designation and notification of a conformity assessment body – Regulation (EU) 2017/745 (MDR) (NBOG F 2017-3)
  6. Applied-for scope of designation and notification of a conformity assessment body – Regulation (EU) 2017/746 (IVDR) (NBOG F 2017-4)
  7. Preliminary assessment review template (MDR) (NBOG F 2017-5)
  8. Preliminary assessment review template (IVDR) (NBOG F 2017-6)
  9. Review of qualification for the authorisation of personnel (MDR) (NBOG F 2017-7)
  10. Review of qualification for the authorisation of personnel (IVDR) (NBOG F 2017-8)

Other documents

Reference

Title

Publication date

UDIWG 2018-1

UDI database. Definitions, descriptions and formats of the UDI core elements

March 2018

UDIWG 2018-2

The architecture of the UDI database - Basic UDI-DI and UDI-DI attributes for medical devices and in-vitro diagnostic medical devices

March 2018

 

Current legislation

Guidance documents to assist stakeholders in implementing directives related to medical devices.

2. MEDDEVs Guidances

The MEDDEVs promote a common approach to be followed by manufacturers and Notified Bodies that are involved in conformity assessment procedures.

- The MEDDEVs are drafted by authorities charged with safeguarding public health. This is in accordance with the relevant annexes of the Directives;
- MEDDEVs are carefully drafted through a consultation process with all interested parties and are subject to a regular updating process;
- These documents have particular reference codes and are endorsed at the Medical Devices Expert Group (MDEG) plenary meetings;
- The guidelines are not legally binding. However, due to the participation of the aforementioned interested parties and the experts from competent authorities, it is expected that the guidelines be followed, ensuring the uniform application of relevant Directive provisions.

Disclaimer: Please note that the amendments introduced by Directive 2007/47/EC or previous amending directives have not yet been incorporated into all MEDDEVs.

List of Guidance MEDDEVs

See below a complete list of all Guidance Meddevs, including links to further information:

2.12 Market surveillance 

MEDDEV 2.12/1 rev.8
Guidelines on a Medical Devices Vigilance System
January 2013

Ⅰ. MEDDEV 2.12/1 rev.8 – Latest Version Forms
MEDDEV 2.12/1 rev. 7 MIR and FSCA are still valid

Active PDF forms 
How to use FSCA and MIR forms
Manufacturer Incident Report - MIR
Field Safety Corrective Action - FSCA
MIR and FSCA xml files (FSCA Report - Incident Report)

Other forms and templates 
Field Safety Notice Template
Trend Report
Periodic Summary Report

EU Vigilance Pilot on Trending – Additional MIR Form
EU Vigilance Pilot MIR form
EU Vigilance Pilot MIR Step-by-Step Guide
EU Vigilance Pilot Toolkit for Users

Ⅱ. Device Specific Vigilance Guidance

DSVG Template
DSVG 00 Introduction to Device Specific Vigilance Guidance
DSVG 01 Cardiac Ablation Vigilance Reporting Guidance
DSVG 02 Coronary Stents Vigilance Reporting Guidance

 Title
2.1 Scope, field of application, definition              MEDDEV 2.1/1 Definitions of “medical devices”, “accessory” and “manufacturer”
April 1994
MEDDEV 2.1/2 rev.2 Field of application of directive “active implantable medical devices”
April 1994
MEDDEV 2.1/2.1 Field of application of directive “active implantable medical devices”
February 1998
MEDDEV 2.1/3 rev.3 Borderline products, drug-delivery products and medical devices incorporating,as integral part, an ancillary medicinal substance or an ancillary human blood derivative 
December 2009
MEDDEV 2.1/4 Interface with other directives – Medical devices/directive89/336/EEC relating to electromagnetic compatibility and directive 89/686/EEC relating to personal protective equipment
March 1994 
For the relation between the MDD and directive 89/686/EEC concerning personal protective equipment, please see the Commission services interpretative document of 21 August 2009
MEDDEV 2.1/5 Medical devices with a measuring function
June 1998
MEDDEV 2.1/6 Qualification and Classification of stand alone software
July 2016
2.2 Essential requirements  MEDDEV 2.2/1 rev.1 EMC requirements
February 1998
MEDDEV 2.2/3 rev.3 “Use by”-date
June 1998
MEDDEV 2.2/4 Conformity assessment of In Vitro Fertilisation (IVF) and Assisted Reproduction Technologies (ART) products
January 2012
2.4 Classification MD MEDDEV 2.4/1 rev.9 Classification of medical devices                                                                               
June 2010
2.5 Conformity
assessment
procedure              
General rules
Quality assurance. GHTF/SG4/N83:2010 - GHTF/SG4/N84:2010
Regulatory auditing of quality systems of medical device manufacturers
(See document in the GHTF-Global Harmonization Task Force)
MEDDEV 2.5/3 rev.2 Subcontracting quality systems related
June 1998
MEDDEV 2.5/5 rev.3 Translation procedure
February 1998
MEDDEV 2.5/6 rev.1 Homogenous batches (verification of manufacturers' products)
February 1998
Conformity assessment for particular groups of products
MEDDEV 2.5/7 rev.1 Conformity assessment of breast implants
July 1998
MEDDEV 2.5/9 rev.1 Evaluation of medical devices incorporating products containing natural rubber latex
February 2004
MEDDEV 2.5/10 Guideline for Authorised Representatives
January 2012
2.7
Clinical investigation, clinical evaluation    
MEDDEV 2.7/1 rev.4 Clinical evaluation: Guide for manufacturers and notified bodies
June 2016 
Appendix 1: Clinical evaluation on coronary stents
December 2008
MEDDEV 2.7/2 rev. 2 Guidelines for Competent Authorities for making a validation/assessment of a clinical investigation application under directives 90/385/EEC and 93/42/EC
September 2015
MEDDEV 2.7/3 rev. 3 Clinical investigations: serious adverse reporting under directives 90/385/EEC and 93/42/EC - SAE reporting form
May 2015
The new SAE reporting form will be taken in use 1 September 2016 at the latest.
MEDDEV 2.7/4 Guidelines on Clinical investigations: a guide for manufacturers and notified bodies
December 2010
2.10 Notified bodies              MEDDEV 2.10/2 rev.1 Designation and monitoring of Notified Bodies within the framework of EC Directives on Medical devices
Annex 1, Annex 2, Annex 3, Annex 4
April 2001
2.12 Market surveillance 

MEDDEV 2.12/1 rev.8
Guidelines on a Medical Devices Vigilance System
January 2013

Ⅰ. MEDDEV 2.12/1 rev.8 – Latest Version Forms
MEDDEV 2.12/1 rev. 7 MIR and FSCA are still valid

Active PDF forms 
How to use FSCA and MIR forms
Manufacturer Incident Report - MIR
Field Safety Corrective Action - FSCA
MIR and FSCA xml files (FSCA Report - Incident Report)

Please note: Some browser plugins are not compatible with PDF forms. If you have problems opening these forms, please save them to your computer and open them from there.

Other forms and templates 
Field Safety Notice Template)
Trend Report
Periodic Summary Report

EU Vigilance Pilot on Trending – Additional MIR Form
EU Vigilance Pilot MIR form
EU Vigilance Pilot MIR Step-by-Step Guide
EU Vigilance Pilot Toolkit for Users

Ⅱ. Device Specific Vigilance Guidance
DSVG Template
DSVG 00 Introduction to Device Specific Vigilance Guidance
DSVG 01 Cardiac Ablation Vigilance Reporting Guidance
DSVG 02 Coronary Stents Vigilance Reporting Guidance

MEDDEV 2.12/2 rev.2 Post Market Clinical Follow-up studies
January 2012
2.13 Transitional period  MEDDEV 2.13 rev.1 Commission communication on the application of transitional provision of Directive 93/42/EEC relating to medical devices (OJ 98/C 242/05)
August 1998
As regards the transitional regime of Directive 2007/47/EC see the 
Interpretative Document of the Commission's services of 5 June 2009
2.14 IVD     MEDDEV 2.14/1 rev.2 Borderline and Classification issues. A guide for manufacturers and notified bodies
January 2012
MEDDEV 2.14/2 rev.1 Research Use Only products
February 2004
MEDDEV 2.14/3 rev.1 Supply of Instructions For Use (IFU) and other information for In-vitro Diagnostic (IVD)Medical Devices
January 2007
Form for the registration of manufacturers and devices In Vitro Diagnostic Medical DeviceDirective, Article 10
January 2007
MEDDEV 2.14/4 CE marking of blood based in vitro diagnostic medical devices for vCJD based on detection of abnormal PrP
January 2012
2.15
Other guidances 
MEDDEV 2.15 rev.3 Committees/Working Groups contributing to the implementation of the Medical Device Directives
December 2008

Matrice Revisioni Certifico:

Rev. Data Oggetoo Autore
4.0 Ottobre 2018 MDCG Documents Certifico Srl
3.0 Agosto 2018 MDCG Documents Certifico Srl
2.0 Agosto 2016 MEDDEV 2.1/6
MEDDEV 2.7/1 rev.4
DSVG Template
DSVG 00 
DSVG 01
DSVG 02
Certifico Srl
1.0 Novembre 2015   Certifico Srl

Collegati



MDCG 2018 -7.pdfAbbonati Marcatura CE4
MDCG 2018 -6.pdfAbbonati Marcatura CE1
List of Giudance MEDDEVs e MDCG Update Ottobre 2018.pdfAbbonati Marcatura CE9
MDCG 2018-5.pdfAbbonati Marcatura CE0
MDCG 2018-4.pdfAbbonati Marcatura CE0
MDCG 2018-3.pdfAbbonati Marcatura CE0
List of Giudance MEDDEVs e MDCG Update Agosto 2018.pdfAbbonati Marcatura CE12
MDCG 2018 1 draft guidance on basic udi_endocx.pdfAbbonati Marcatura CE3
MDCG 018_2_nomenclature_en.pdfAbbonati Marcatura CE2
01_NBOG_BPG_2017_1_rev 3.pdfAbbonati Marcatura CE2
02_NBOG_BPG_2017_2_rev1.pdfAbbonati Marcatura CE1
03_NBOG_F_2017_1_MDR_rev3.docxAbbonati Marcatura CE1
04_NBOG_F_2017_2_IVDR_rev3.docxAbbonati Marcatura CE1
05_NBOG_F_2017_3_MDR rev2.docxAbbonati Marcatura CE1
06_NBOG_F_2017_4_IVDR rev2.docxAbbonati Marcatura CE1
07_NBOG_F_2017_5_MDR_rev1.docxAbbonati Marcatura CE1
08_NBOG_F_2017_6_IVDR_rev1.docxAbbonati Marcatura CE2
09_NBOG_F_2017_7_MDR_rev1.docAbbonati Marcatura CE1
10_NBOG_F_2017_8_IVDR_rev1.docAbbonati Marcatura CE1
UDIWG 2018_1_guidance_core_elements_en.pdfAbbonati Marcatura CE0
UDIWG 2018_2_architecture_udidb_en.pdfAbbonati Marcatura CE0
55 2_15_3___12-2008_en.pdfAbbonati Marcatura CE205
54 2_14_4_ol_en.pdfAbbonati Marcatura CE196
53 ivd_notification_form_en.pdfAbbonati Marcatura CE254
52 2_14_3_rev1_ifu_final_en.pdfAbbonati Marcatura CE198
51 2_14_2_research_only_product_en.pdfAbbonati Marcatura CE202
50 2_14_1_rev2_ol_en.pdfAbbonati Marcatura CE212
49 transitionalperiod_2007-47-ec_guidance_final_en.pdfAbbonati Marcatura CE181
48 C242_5 del 01_08_1998 IT.pdfAbbonati Marcatura CE194
47 2_12_2_ol_en.pdfAbbonati Marcatura CE347
46 dsvg02_coronary_stents_en.pdfAbbonati Marcatura CE312
45 dsvg01_cardiac_ablation_en.pdfAbbonati Marcatura CE270
44 dsvg_00_en.pdfAbbonati Marcatura CE302
43 dsvg_template_en.pdfAbbonati Marcatura CE192
42 eu_pilot_toolkit_components_list_en.pdfAbbonati Marcatura CE182
41 guide_mir_pilot_en.pdfAbbonati Marcatura CE195
40 mir_pilot2_en.pdfAbbonati Marcatura CE189
39 form_2_12_1_rev7_psr_en.pdfAbbonati Marcatura CE490
38 form_2_12_1_rev7_trend_en.pdfAbbonati Marcatura CE209
37 2_12_1_fsn_en.pdfAbbonati Marcatura CE251
36 incident Report V2.26en.pdfAbbonati Marcatura CE195
35 FSCA Report V2.7en.pdfAbbonati Marcatura CE212
34 2_12_1-fsca_en.pdfAbbonati Marcatura CE235
33 2_12_1-mir_en.pdfAbbonati Marcatura CE271
32 mir_fsca_use_en.pdfAbbonati Marcatura CE216
31 2_ 12-1_rev8_en.pdfAbbonati Marcatura CE703
30 2_10-2annex4_04-2001_en.pdfAbbonati Marcatura CE191
29 2_10-2annex3_04-2001_en.pdfAbbonati Marcatura CE179
28 2_10-2annex2_04-2001_en.pdfAbbonati Marcatura CE186
27 2_10-2annex1_04-2001_en.pdfAbbonati Marcatura CE169
26 2_10_2date04_2001_en.pdfAbbonati Marcatura CE191
25 2_7_4_en.pdfAbbonati Marcatura CE258
24 sae_reporting_form_en.pdfAbbonati Marcatura CE246
23_0 2_7_1_rev_3_2015_en.pdfAbbonati Marcatura CE253
23 2_7_2_rev2_en.pdfAbbonati Marcatura CE215
22 cetf_en.pdfAbbonati Marcatura CE225
21 2_7_1_rev4_en.pdfAbbonati Marcatura CE405
20 2_5_10_ol_en.pdfAbbonati Marcatura CE194
19 2_5_9rev_latex_en.pdfAbbonati Marcatura CE192
18 2_5-7____07-1998_en.pdfAbbonati Marcatura CE174
17 2_5-6____02-1998_en.pdfAbbonati Marcatura CE185
16 2_5-5____02-1998_en.pdfAbbonati Marcatura CE187
15 2_5-3____06-1998_en.pdfAbbonati Marcatura CE184
14 ghtf-sg4-n84-2010-guidelines-for-auditing-qms-part-5-control-of-suppliers-100827.pdfAbbonati Marcatura CE214
13 ghtf-sg4-n83-2010-guidelines-for-auditing-qms-part-4-multiple-sites-100827.pdfAbbonati Marcatura CE217
12 2_4_1_rev_9_classification_en.pdfAbbonati Marcatura CE412
11 2_2_4_ol_en.pdfAbbonati Marcatura CE237
10 2_2-3___06-1998_en.pdfAbbonati Marcatura CE204
09 2_2-1____02-1998_en.pdfAbbonati Marcatura CE198
08 2_1_6_072016_en.pdfAbbonati Marcatura CE368
07 2_1_5____06-1998_en.pdfAbbonati Marcatura CE199
06 interpretative_ppe_2009_en.pdfAbbonati Marcatura CE192
05 2_1_4____03-1994_en.pdfAbbonati Marcatura CE243
04 2_1_3_rev_3-12_2009_en.pdfAbbonati Marcatura CE254
03 2_1_2-1__02-1998_en.pdfAbbonati Marcatura CE203
02 2_1-2___04-1994_en.pdfAbbonati Marcatura CE215
01 2_1-1___04-1994_en.pdfAbbonati Marcatura CE276
List of Giudance MEDDEVs Update Agosto 2016.pdfAbbonati Marcatura CE118
List of Giudance MEDDEVs Update Novembre 2015.pdfAbbonati Marcatura CE220

Tags: Marcatura CE Direttiva Dispositivi medici Abbonati Marcatura CE

Ultime Guide UE

Guide UE più lette