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Raccolta Linee guida MEDDEV Dispositivi medici

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Raccolta Linee guida MEDDEV Dispositivi medici

Update Rev. 12.0 Ottobre 2019 (08.10.2019)

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

New Rev. 12.0 Ottobre 2019:

- MDCG 2019-10 Application of transitional provisions concerning validity of certificates issued in accordance to Directives 90/385/EEC and 93/42/EEC

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 2019-10

Application of transitional provisions concerning validity of certificates issued in accordance to Directives 90/385/EEC and 93/42/EEC

October 2019
MDCG 2019-9

 

MDCG 2019-9 Summary of safety and clinical performance A guide for manufacturers and notified bodies

September 2019
MDCG 2019-8

Medical Devices: Guidance document Implant Card relating to the application of Article 18 Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices

July 2019
MDCG 2019-7 Guidance on Article 15 of the Medical Device Regulation (MDR) and in vitro Diagnostic Device Regulation (IVDR) regarding a ‘person responsible for regulatory compliance’ (PRRC) June 2019
MDCG 2019-6 Questions and answers: Requirements relating to notified bodies June 2019
MDCG 2019-5 Registration of legacy devices in EUDAMED April 2019

MDCG 2019-4

Timelines for registration of device data elements in EUDAMED

April 2019

MDCG 2019-3

Interpretation of Article 54(2)b

March 2019

MDCG 2019-2

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

Febraury 2019

MDCG 2019-1

MDCG guiding principles for issuing entities rules on Basic UDI-DI

January 2019

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Draft guidance on basic UDI-DI and changes to UDI-DI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
MDCG 2018-8

Guidance on content of the certificates, voluntary certificate transfers

November 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

Additional Guidance Regarding the Vigilance System as outlined in MEDDEV 2.12-1 rev. 8
July 2019

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
DSVG 03 - Cardiac Implantable Electronic Devices (CIED) - Guidance on the vigilance system for CE-marked medical devices
DSVG 04 - Breast Implants - Guidance on the vigilance system for CE-marked medical devices

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 Oggetto Autore
12.0 08 Ottobre 2019 MDCG 2019-10 Application of transitional provisions concerning validity of certificates issued in accordance to Directives 90/385/EEC and 93/42/EEC Certifico Srl
11.0 27 Settembre 2019 MDCG 2019-9 Summary of safety and clinical performance
A guide for manufacturers and notified bodies
DSVG 03 - Cardiac Implantable Electronic Devices (CIED) 
Guidance vigilance system for CE-marked medical devices
DSVG 04 - Breast Implants
Guidance vigilance system for CE-marked medical devices
Certifico Srl
10.0 12 Luglio MDCG Documents
Additional Guidance Regarding
the Vigilance System MEDDEV 2.12-1 rev. 8
Certifico Srl
9.0 16 Aprile 2019 MDCG Documents Certifico Srl
8.0 22 Marzo 2019 MDCG Documents Certifico Srl
7.0 19 Febbraio 2019 MDCG Documents Certifico Srl
6.0 Febbraio 2019 MDCG Documents Certifico Srl
5.0 Gennaio 2019 MDCG Documents Certifico Srl
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

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MDCG 2019_10_application_transitional_provisions_certificates.pdfAbbonati Marcatura CE2
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53 ivd_notification_form_en.pdfAbbonati Marcatura CE257
52 2_14_3_rev1_ifu_final_en.pdfAbbonati Marcatura CE201
51 2_14_2_research_only_product_en.pdfAbbonati Marcatura CE205
50 2_14_1_rev2_ol_en.pdfAbbonati Marcatura CE215
49 transitionalperiod_2007-47-ec_guidance_final_en.pdfAbbonati Marcatura CE184
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41 guide_mir_pilot_en.pdfAbbonati Marcatura CE198
40 mir_pilot2_en.pdfAbbonati Marcatura CE191
39 form_2_12_1_rev7_psr_en.pdfAbbonati Marcatura CE493
38 form_2_12_1_rev7_trend_en.pdfAbbonati Marcatura CE212
37 2_12_1_fsn_en.pdfAbbonati Marcatura CE253
36 incident Report V2.26en.pdfAbbonati Marcatura CE197
35 FSCA Report V2.7en.pdfAbbonati Marcatura CE215
34 2_12_1-fsca_en.pdfAbbonati Marcatura CE238
33 2_12_1-mir_en.pdfAbbonati Marcatura CE274
32 mir_fsca_use_en.pdfAbbonati Marcatura CE218
31 2_ 12-1_rev8_en.pdfAbbonati Marcatura CE706
30 2_10-2annex4_04-2001_en.pdfAbbonati Marcatura CE194
29 2_10-2annex3_04-2001_en.pdfAbbonati Marcatura CE182
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