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Raccolta Linee guida MEDDEV Dispositivi medici

ID 2047 | | Visite: 99523 | Guide Nuovo ApproccioPermalink: https://www.certifico.com/id/2047

Raccolta Linee guida MEDDEV Dispositivi medici / Update Febbraio 2024

ID 2047 | Update Rev. 34.0 2023 (26.02.2024)

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

Download 0. Raccolta linee guida MEDDEV e MDCG Indice 26.02.2024

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New Rev. 34.0 del 26 Febbraio 2024:

- MDCG 2024-2 Procedures for the updates of the EMDN February 2024
- MDCG 2024-1-4 DSVG 04 on Breast implants 4 January 2024
- MDCG 2024-1-3 DSVG 03 on Cardiac implantable electronic devices (CIEDs) January 2024
- MDCG 2024-1-2 DSVG 02 on Coronary stents January 2024
- MDCG 2024-1-1 DSVG 01 on Cardiac ablation January 2024
- MDCG 2024-1 Device Specific Vigilance Guidance (DSVG) Template January 2024
- MDCG 2023-7 Guidance on exemptions from the requirements to perform clinical investigations pursuant to Article 61(4)-(6) MDR and on ‘sufficient levels of access’ to data needed to justify claims of equivalence December 2023
- MDCG 2023-6 Guidance on demonstration of equivalence for Annex XVI products - A guide for manufacturers and notified bodies December 2023
- MDCG 2023-5 Guidance on qualification and classification of Annex XVI products - A guide for manufacturers and notified bodies December 2023
- MDCG 2022-11 - Rev.1 MDCG Position Paper: Notice to manufacturers to ensure timely compliance with MDR and IVDR requirements November 2023
- MDCG 2021-27 - Rev.1 Questions and Answers on Articles 13 & 14 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746 December 2023
- MDCG 2021-6 - Rev.1 Regulation (EU) 2017/745 – Questions & Answers regarding clinical investigation December 2023
- MDCG 2019-7 - Rev.1 Guidance on article 15 of the medical device regulation (MDR) and in vitro diagnostic device regulation (IVDR) on a ‘person responsible for regulatory compliance’ (PRRC) December 2023
________

Regolamento (UE) 2017/745 concernente i dispositivi medici (si applica dal 20 Maggio 2021)

In calce all'articolo pdf "List of Guidance MEDDEVs e MDCG Rev. 33.0 Update 28.09.2023" riservato Abbonati

New regulations

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

1. MDCG Documents

MDCG endorsed documents

Reference Title Publication date

MDCG 2024-2  Procedures for the updates of the EMDN February 2024
MDCG 2024-1-4  DSVG 04 on Breast implants 4 January 2024
MDCG 2024-1-3  DSVG 03 on Cardiac implantable electronic devices (CIEDs) January 2024
MDCG 2024-1-2  DSVG 02 on Coronary stents January 2024
MDCG 2024-1-1  DSVG 01 on Cardiac ablation January 2024
MDCG 2024-1  Device Specific Vigilance Guidance (DSVG) Template January 2024
MDCG 2023-7 Guidance on exemptions from the requirements to perform clinical investigations pursuant to Article 61(4)-(6) MDR and on ‘sufficient levels of access’ to data needed to justify claims of equivalence  December 2023
MDCG 2023-6  Guidance on demonstration of equivalence for Annex XVI products - A guide for manufacturers and notified bodies  December 2023
MDCG 2023-5  Guidance on qualification and classification of Annex XVI products - A guide for manufacturers and notified bodies  December 2023
MDCG 2022-11 - Rev.1  MDCG Position Paper: Notice to manufacturers to ensure timely compliance with MDR and IVDR requirements November 2023
MDCG 2021-27 - Rev.1  Questions and Answers on Articles 13 & 14 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746  December 2023
MDCG 2021-6 - Rev.1  Regulation (EU) 2017/745 – Questions & Answers regarding clinical investigation  December 2023
MDCG 2019-7 - Rev.1  Guidance on article 15 of the medical device regulation (MDR) and in vitro diagnostic device regulation (IVDR) on a ‘person responsible for regulatory compliance’ (PRRC)  December 2023
MDCG 2023-3 Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 on medical devices February 2023
MDCG 2023-2
MDR form List of Standard
List of Standard Fees January 2023
MDCG 2023-2
IVDR form List of Standard 
List of Standard Fees January 2023
MDCG 2023-2 List of Standard Fees  January 2023
MDCG 2023-1  Guidance on the health institution exemption under Article 5(5) of Regulation (EU) 2017/745 and Regulation (EU) 2017/746 January 2023
MDCG 2022- 21 Guidance on Periodic Safety Update Report (PSUR) according to Regulation (EU) 2017/745  December 2022
MDCG 2022- 20 Substantial modification of performance study under Regulation (EU) 2017/746  December 2022
MDCG 2022-19 Performance study application/notification documents under Regulation (EU) 2017/746  December 2022
Q&A Rev. 1 Q&A on practical aspects related to the implementation of Regulation (EU) 2023/607 - Extension of the MDR transitional period and removal of the “sell off” periods July 2023
MDCG 2022-18 ADD.1 MDCG Position Paper on the application of Article 97 MDR to legacy devices for which the MDD or AIMDD certificate expires before the issuance of a MDR certificate - Addendum 1 June 2023
MDCG 2022-18 MDCG Position Paper on the application of Article 97 MDR to legacy devices for which the MDD or AIMDD certificate expires before the issuance of a MDR certificate  December 2022
MDCG 2022-17 MDCG position paper on "hybrid audits"  December 2022
MDCG 2022-16 Guidance on Authorised Representatives Regulation (EU) 2017/745 and Regulation (EU) 2017/746  October 2022
MDCG 2022-15 Guidance on appropriate surveillance regarding the transitional provisions under Article 110 of the IVDR with regard to devices covered by certificates according to the IVDD  September 2022
MDCG 2022-14 Transition to the MDR and IVDR - Notified body capacity and availability of medical devices and IVDs  August 2022
MDCG 2022-13 Designation, re-assessment and notification of conformity assessment bodies and notified bodies August 2022
MDCG 2022-12 Guidance on harmonised administrative practices and alternative technical solutions until Eudamed is fully functional (for Regulation (EU) 2017/746 on in vitro diagnostic medical devices) July 2022
MDCG 2022-11 MDCG Position Paper: Notice to manufacturers to ensure timely compliance with MDR requirements May 2022
MDCG 2022-10 Q&A on the interface between Regulation (EU) 536/2014 on clinical trials for medicinal products for human use (CTR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) May 2022
MDCG 2022-9 Summary of safety and performance template May 2022
MDCG 2022-8 Regulation (EU) 2017/746 - application of IVDR requirements to ‘legacy devices’ and to devices placed on the market prior to 26 May 2022 in accordance with Directive 98/79/EC May 2022
MDCG 2022-7 Q&A on the Unique Device Identification system under Regulation (EU) 2017/745 and Regulation (EU) May 2022
MDCG 2022-6 Guidance on significant changes regarding the transitional provision under Article 110(3) of the IVDR May 2022
MDCG 2022-5 Guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical May 2022
MDCG 2022-4 rev.1 Guidance on appropriate surveillance regarding the transitional provisions under Article 120 of the MDR with regard to devices covered by certificates according to the MDD or the AIMDD  December 2022
MDCG 2022-4 Guidance on appropriate surveillance regarding the transitional provisions under Article 120 of the MDR February 2022
MDCG 2022-3 Verification of manufactured class D IVDs by notified bodies  February 2022
MDCG 2022-2 Guidance on general principles of clinical evidence for In Vitro Diagnostic medical devices (IVDs) January 2022
MDCG 2022-1 Notice to 3rd country manufacturers of SARS-CoV-2 in vitro diagnostic medical devices January 2022
MDCG 2021-28 Substantial modification of clinical investigation under Medical Device Regulation December 2021
MDCG 2021-27 Questions and Answers on Articles 13 & 14 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746 December 2021
MDCG 2021-26 Questions and Answers on repackaging & relabelling activities under Article 16 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746 October 2021
MDCG 2021-25 Regulation (EU) 2017/745 - application of MDR requirements to ‘legacy devices’ and to devices placed on the market prior to 26 May 2021 in accordance with Directives 90/385/EEC or 93/42/EEC October 2021
MDCG 2021-24 Guidance on classification of medical devices October 2021
Helsinki Procedure Helsinki Procedure for borderline and classification under MDR & IVDR September 2021
MDCG 2021-23 Guidance for notified bodies, distributors and importers onClarification on “first certification for that type of device” and corresponding procedures to be followed by notified bodies, in context of the consultation of the expert panel referred to in Article 48(6) of Regulation (EU) 2017/746 August 2021
MDCG 2021-22 Clarification on “first certification for that type of device” and corresponding procedures to be followed by notified bodies, in context of the consultation of the expert panel referred to in Article 48(6) of Regulation (EU) 2017/746 August 2021
MDCG 2021-21 Guidance on performance evaluation of SARS-CoV-2 in vitro diagnostic medical devices August 2021
MDCG 2021-20 Instructions for generating CIV-ID for MDR Clinical Investigations July 2021
MDCG 2021-19 Guidance note integration of the UDI within an organisation’s quality management system July 2021
MDCG 2021-18 Applied-for scope of designation and notification of a conformity assessment body – Regulation (EU) 2017/746 (IVDR) July 2021
MDCG 2021-17 Applied-for scope of designation and notification of a conformity assessment body – Regulation (EU) 2017/745 (MDR) July 2021
MDCG 2021-16 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) July 2021
MDCG 2021-15 Application form to be submitted by a conformity assessment body when applying for designation as notified body under the medical devices regulation (MDR) July 2021
MDCG 2021-14 Explanatory note on IVDR codes July 2021
MDCG 2021-13 rev. 1.0 Questions and answers on obligations and related rules for the registration in EUDAMED of actors other than manufacturers, authorised representatives and importers subject to the obligations of Article 31 MDR and Article 28 IVDR July 2021
MDCG 2021-12 FAQ on the European Medical Device Nomenclature (EMDN) May 2021
MDCG 2021-11 Guidance on Implant Card – Device types May 2021
MDCG 2021-10 The status of Appendixes E-I of IMDRF N48 under the EU regulatory framework for medical devices May 2021
MDCG 2021-9 MDCG Position Paper on the Implementation of UDI requirements for contact lenses, spectacle frames, spectacle lenses & ready readers May 2021
MDCG 2021-8 Clinical investigation application/notification documents May 2021
MDCG 2021-7 Notice to manufacturers and authorised representatives on the impact of genetic variants on SARS-COV-2 in vitro diagnostic medical devices May 2021
MDCG 2021-6 Regulation (EU) 2017/745 – Questions & Answers regarding clinical investigation  May 2021
MDCG 2021-5 Guidance on standardisation for medical devices April 2021
MDCG 2021-4 Application of transitional provisions for certification of class D in vitro diagnostic medical devices according to Regulation (EU) 2017/746 April 2021
MDCG 2021-3 Questions and Answers on Custom-Made Devices March 2021
MDCG 2021-2 Guidance on state of the art of COVID-19 rapid antibody tests March 2021
MDCG 2021-1 Guidance on harmonised administrative practices and alternative technical solutions until EUDAMED is fully functional Febraury 2021
MDCG 2020-18 MDCG Position Paper on UDI assignment for Spectacle lenses & Ready readers December 2020
MDCG 2020-17 Questions and Answers related to MDCG 2020-4:
“Guidance on temporary extraordinary measures related to medical device notified body audits during COVID-19 quarantine orders and travel restrictions”
December 2020

MDCG 2020-16 Rev.2

Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746   Febraury 2023 
MDCG 2020-16 Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746 November 2020
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
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 Diagnostic medical devices Regulation (IVDR) August 2020
MDCG 2020-13 Clinical evaluation assessment report template July 2020
MDCG 2020-12 Guidance on transitional provisions for consultations of authorities on devices incorporating a substance which may be  considered a medicinal product and which  has action ancillary to that of the device,  as well as on devices manufactured using TSE susceptible animal tissues June 2020
MDCG 2020-11 Safety reporting in clinical investigations of medical devices under the Regulation (EU) 2017/745 May 2020
MDCG 2020-10-2 Clinical Investigation Summary Safety Report Form v1.0 May 2020
MDCG 2020-10-1 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 Implementing Regulation (EU) 2020/666 amending Commission Implementing Regulation May 2020
MDCG 2020-9 Regulatory requirements for ventilators and related accessories April 2020
MDCG 2020-8 Post-market clinical follow-up (PMCF) Evaluation Report Template April 2020
MDCG 2020-7 Post-market clinical follow-up (PMCF) Plan Template April 2020
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  April 2020
MDCG 2020-5 Clinical Evaluation - Equivalence  April 2020
MDCG 2020-4 Guidance on temporary extraordinary measures related to medical device Notified Body audits during COVID-19 quarantine orders and travel restrictions April 2020
MDCG 2020-3 Rev.1 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 September 2023
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 March 2020
MDCG 2020-2 Class I Transitional provisions under Article 120 (3 and 4) – (MDR) March 2020
MDCG 2020-1 Guidance on Clinical Evaluation (MDR) / Performance Evaluation (IVDR) of Medical Device Software  March 2020
MDCG 2019-16 Guidance on Cybersecurity for medical devices December 2019
MDCG 2019-15 Guidance notes for manufacturers of class I medical devices December 2019
MDCG 2019-14 Explanatory note on MDR codes December 2019
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 December 2019
MDCG 2019-12 Designating authority's final assessment form: Key information (EN) October 2019
MDCG 2019-11

Qualification and classification of software - Regulation (EU) 2017/745 and Regulation (EU) 2017/746

October 2019
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 v2

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

March 2020
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 v3 Questions and answers: Requirements relating to notified bodies October 2021
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 Rev.1 April 2020
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 v3 Guidance on BASIC UDI-DI and changes to UDI-DI March 2020
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 Version 7.2.1
Field Safety Corrective Action - FSCA
MIR and FSCA xml files (FSCA Report - Incident Report) Version 7.2.1

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
34.0 26.02.2024

MDCG 2024-2 Procedures for the updates of the EMDN February 2024
MDCG 2024-1-4 DSVG 04 on Breast implants 4 January 2024
MDCG 2024-1-3 DSVG 03 on Cardiac implantable electronic devices (CIEDs) January 2024
MDCG 2024-1-2 DSVG 02 on Coronary stents January 2024
MDCG 2024-1-1 DSVG 01 on Cardiac ablation January 2024
MDCG 2024-1 Device Specific Vigilance Guidance (DSVG) Template January 2024
MDCG 2023-7 Guidance on exemptions from the requirements to perform clinical investigations pursuant to Article 61(4)-(6) MDR and on ‘sufficient levels of access’ to data needed to justify claims of equivalence December 2023
MDCG 2023-6 Guidance on demonstration of equivalence for Annex XVI products - A guide for manufacturers and notified bodies December 2023
MDCG 2023-5 Guidance on qualification and classification of Annex XVI products - A guide for manufacturers and notified bodies December 2023
MDCG 2022-11 - Rev.1 MDCG Position Paper: Notice to manufacturers to ensure timely compliance with MDR and IVDR requirements November 2023
MDCG 2021-27 - Rev.1 Questions and Answers on Articles 13 & 14 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746 December 2023
MDCG 2021-6 - Rev.1 Regulation (EU) 2017/745 – Questions & Answers regarding clinical investigation December 2023
MDCG 2019-7 - Rev.1 Guidance on article 15 of the medical device regulation (MDR) and in vitro diagnostic device regulation (IVDR) on a ‘person responsible for regulatory compliance’ (PRRC) December 2023

Certifico Srl 
33.0 28.09.2023

- MDCG 2023-3 Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 on medical devices Febraury 2023
- Q&A Rev. 1 Q&A on practical aspects related to the implementation of Regulation (EU) 2023/607 - Extension of the MDR transitional period and removal of the “sell off” periods July 2023
- MDCG 2022-18 ADD.1 MDCG Position Paper on the application of Article 97 MDR to legacy devices for which the MDD or AIMDD certificate expires before the issuance of a MDR certificate - Addendum 1 June 2023
- MDCG 2020-16 Rev.2 Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746 Febraury 2023
- MDCG 2020-3 Rev.1 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 September 2023

Certifico Srl 
32.0 24.01.2023 - MDCG 2023-2 MDR form List of Standard Fees January 2023
- MDCG 2023-2 IVDR form List of Standard Fees January 2023
- MDCG 2023-2 List of Standard Fees January 2023
- MDCG 2023-1 Guidance on the health institution exemption under Article 5(5) of Regulation (EU) 2017/745 and Regulation (EU) 2017/746 January 2023
- MDCG 2022-21 Guidance on Periodic Safety Update Report (PSUR) according to Regulation (EU) 2017/745 December 2022
- MDCG 2022-20 Substantial modification of performance study under Regulation (EU) 2017/746 December 2022
- MDCG 2022-19 Performance study application/notification documents under Regulation (EU) 2017/746 December 2022
- MDCG 2022-18 MDCG Position Paper on the application of Article 97 MDR to legacy devices for which the MDD or AIMDD certificate expires before the issuance of a MDR certificate December 2022
- MDCG 2022-17 MDCG position paper on "hybrid audits" December 2022
- MDCG 2022-16 Guidance on Authorised Representatives Regulation (EU) 2017/745 and Regulation (EU) 2017/746 October 2022
- MDCG 2022-15 Guidance on appropriate surveillance regarding the transitional provisions under Article 110 of the IVDR with regard to devices covered by certificates according to the IVDD September 2022
- MDCG 2022-14 Transition to the MDR and IVDR - Notified body capacity and availability of medical devices and IVDs August 2022
- MDCG 2022-4 rev.1 Guidance on appropriate surveillance regarding the transitional provisions under Article 120 of the MDR with regard to devices covered by certificates according to the MDD or the AIMDD December 2022
Certifico Srl
31.0 07.09.2022  MDCG 2022-13 Designation, re-assessment and notification of conformity assessment bodies and notified bodies
MDCG 2022-12 Guidance on harmonised administrative practices and alternative technical solutions until Eudamed is fully functional (for Regulation (EU) 2017/746 on in vitro diagnostic medical devices)
Certifico Srl
30.0  06.07.2022 MDCG 2022-11 MDCG Position Paper: Notice to manufacturers to ensure timely compliance with MDR requirements 
MDCG 2022-10 Q&A on the interface between Regulation (EU) 536/2014 on clinical trials for medicinal products for human use (CTR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR)          
MDCG 2022-9 Summary of safety and performance template        
MDCG 2022-8 Regulation (EU) 2017/746 - application of IVDR requirements to ‘legacy devices’ and to devices placed on the market prior to 26 May 2022 in accordance with Directive 98/79/EC   
MDCG 2022-7 Q&A on the Unique Device Identification system under Regulation (EU) 2017/745 and Regulation (EU)
MDCG 2022-6 Guidance on significant changes regarding the transitional provision under Article 110(3) of the IVDR
Certifico Srl
29.0 20.05.2022

MDCG 2022 - 5 Guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical

Certifico Srl
28.0 23.03.2022

MDCG 2022-4 Guidance on appropriate surveillance regarding the transitional provisions under Article 120 of the MDR
MDCG 2022-3 Verification of manufactured class D IVDs by notified bodies

Certifico Srl
27.0 01.02.2022

MDCG 2022-2 Guidance on general principles of clinical evidence for In Vitro Diagnostic medical devices (IVDs)
MDCG 2022-1 Notice to 3rd country manufacturers of SARS-CoV-2 in vitro diagnostic medical devices
MDCG 2021-28 Substantial modification of clinical investigation under Medical Device Regulation
MDCG 2021-27 Questions and Answers on Articles 13 & 14 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746

Certifico Srl
26.0 15.11.2021

MDCG 2021-26 - Questions and Answers on repackaging & relabelling activities under Article 16 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746
MDCG 2021-25 - Regulation (EU) 2017/745 - application of MDR requirements to ‘legacy devices’ and to devices placed on the market prior to 26 May 2021 in accordance with Directives 90/385/EEC or 93/42/EEC
MDCG 2019-6 v3 - Questions and answers: Requirements relating to notified bodies

Certifico Srl
25.0 16.10.2021

MDCG 2021-24 Guidance on classification of medical devices October 2021
Helsinki Procedure Helsinki Procedure for borderline and classification under MDR & IVDR September 2021

Certifico Srl
24.0 10 Settembre 2021

MDCG 2021-6 Regulation (EU) 2017/745 – Questions & Answers regarding clinical investigation April 2021
MDCG 2021-7 Notice to manufacturers and authorised representatives on the impact of genetic variants on SARS-COV-2 in vitro diagnostic medical devices May 2021
MDCG 2021-08 Clinical investigation application/notification documents May 2021
MDCG 2021-09 MDCG Position Paper on the Implementation of UDI requirements for contact lenses, spectacle frames, spectacle lenses & ready readers May 2021
MDCG 2021-10 - The status of Appendixes E-I of IMDRF N48 under the EU regulatory framework for medical devices May 2021
MDCG 2021-11 Guidance on Implant Card – Device types May 2021
MDCG 2021-12 FAQ on the European Medical Device Nomenclature (EMDN) June 2021
MDCG 2021-13 Rev. 1 Questions and answers on obligations and related rules for the registration in EUDAMED of actors other than manufacturers, authorised representatives and importers subject to the obligations of Article 31 MDR and Article 28 IVDR July 2021
MDCG 2021-14 Explanatory note on IVDR codes July 2021
MDCG 2021-15 Application form to be submitted by a conformity assessment body when applying for designation as notified body under the medical devices regulation (MDR) July 2021
MDCG 2021-16 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) July 2021
MDCG 2021-17 Applied-for scope of designation and notification of a conformity assessment body – Regulation (EU) 2017/745 (MDR) July 2021
MDCG 2021-18 Applied-for scope of designation and notification of a conformity assessment body – Regulation (EU) 2017/746 (IVDR) July 2021
MDCG 2021-19 Guidance note integration of the UDI within an organisation’s quality management system July 2021
MDCG 2021-20 Instructions for generating CIV-ID for MDR Clinical Investigations July 2021
MDCG 2021-21 Guidance on performance evaluation of SARS-CoV-2 in vitro diagnostic medical devices August 2021
MDCG 2021-22 Clarification on “first certification for that type of device” and corresponding procedures to be followed by notified bodies, in context of the consultation of the expert panel referred to in Article 48(6) of Regulation (EU) 2017/746 August 2021
MDCG 2021-23 Guidance for notified bodies, distributors and importers onClarification on “first certification for that type of device” and corresponding procedures to be followed by notified bodies, in context of the consultation of the expert panel referred to in Article 48(6) of Regulation (EU) 2017/746 August 2021

Certifico Srl
23.0 22 Aprile 2021

MDCG 2021-5 Guidance on standardisation for medical devices 
MDCG 2021-4 Application of transitional provisions for certification of class D in vitro diagnostic medical devices according to Regulation (EU) 2017/746  

MDCG 2021-3 Questions and Answers on Custom-Made Devices           
MDCG 2021-2 Guidance on state of the art of COVID-19 rapid antibody tests     
MDCG 2021-1 Guidance on harmonised administrative practices and alternative technical solutions until EUDAMED is fully functional       
MDCG 2020-18 MDCG Position Paper on UDI assignment for Spectacle lenses & Ready readers
MDCG 2020-17 Questions and Answers related to MDCG 2020-4: “Guidance on temporary extraordinary measures related to medical device notified body audits during COVID-19 quarantine orders and travel restrictions”
MDCG 2020-16 Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746  
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
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 Diagnostic medical devices Regulation (IVDR)   
MDCG 2020-13 Clinical evaluation assessment report template

Certifico Srl
22.0 07 Luglio 2020

MDCG 2020-12
- Manufacturer Incident Report - MIR Version 7.2.1
- MIR and FSCA xml files (FSCA Report - Incident Report) Version 7.2.1

Certifico Srl
21.0 28 Maggio 2020

MDCG 2020-11
MDCG 2020-10-2
MDCG 2020-10-1

Certifico Srl
20.0 29 Aprile 2020

MDCG 2020-9

Certifico Srl
19.0 26 Aprile 2020

MDCG 2020-5
MDCG 2020-6
MDCG 2020-7
MDCG 2020-8

Certifico Srl
18.0 09 Aprile 2020

MDCG 2019-3
MDCG 2020-4

Certifico Srl
17.0 18 Marzo 2020

MDCG 2020-3
MDCG 2020-2
MDCG 2020-1
MDCG 2019-8 v2
MDCG 2018-1 v3

Certifico Srl
16.0 08 Gennaio 2020

Guidance on Cybersecurity for medical devices

Certifico Srl
15.0 18 Dicembre 2019

Guidance notes for manufacturers of class I medical devices

Certifico Srl
14.0 11 Dicembre 2019

- MDCG 2019-14 Explanatory note on MDR codes
- MDCG 2019-13 Guidance on sampling of MDR Class IIa/ Class IIb 
and IVDR Class B / Class C devices
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Certifico Srl
13.0 30 Novembre 2019

Qualification and classification of software
Regulation (EU) 2017/745 and Regulation (EU) 2017/746

Designating authority's final assessment form: Key information (EN)
Certifico Srl
12.0 08 Ottobre 2019 MDCG 2019-10 Application of transitional provisions
concerningvalidity 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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98 kB 330
Allegato riservato 45 dsvg01_cardiac_ablation_en.pdf
Device Specific Vigilance Guidance
98 kB 285
Allegato riservato 44 dsvg_00_en.pdf
Device Specific Vigilance Guidance
21 kB 321
Allegato riservato 43 dsvg_template_en.pdf
Device Specific Vigilance Guidance
24 kB 213
Allegato riservato 42 eu_pilot_toolkit_components_list_en.pdf
EU Vigilance Pilot on Trending – Additional MIR Form
24 kB 201
Allegato riservato 41 guide_mir_pilot_en.pdf
EU Vigilance Pilot on Trending – Additional MIR Form
244 kB 214
Allegato riservato 40 mir_pilot2_en.pdf
EU Vigilance Pilot on Trending – Additional MIR Form
609 kB 205
Allegato riservato 39 form_2_12_1_rev7_psr_en.pdf
Other forms and templates
80 kB 507
Allegato riservato 38 form_2_12_1_rev7_trend_en.pdf
Other forms and templates
79 kB 224
Allegato riservato 37 2_12_1_fsn_en.pdf
Other forms and templates
28 kB 267
Allegato riservato 36 incident Report V2.26en.pdf
Incident report V2.26 - Active PDF forms
190 kB 215
Allegato riservato 35 FSCA Report V2.7en.pdf
FSCA Report V2.7 - Active PDF forms
1041 kB 232
Allegato riservato 34 2_12_1-fsca_en.pdf
Active PDF forms
1378 kB 254
Allegato riservato 33 2_12_1-mir_en.pdf
Active PDF forms
970 kB 290
Allegato riservato 32 mir_fsca_use_en.pdf
Active PDF forms
13 kB 232
Allegato riservato 31 2_ 12-1_rev8_en.pdf
MEDDEV - January 2013
1249 kB 724
Allegato riservato 30 2_10-2annex4_04-2001_en.pdf
MEDDEV - April 2001
28 kB 210
Allegato riservato 29 2_10-2annex3_04-2001_en.pdf
MEDDEV - April 2001
19 kB 198
Allegato riservato 28 2_10-2annex2_04-2001_en.pdf
MEDDEV - April 2001
16 kB 207
Allegato riservato 27 2_10-2annex1_04-2001_en.pdf
MEDDEV - April 2001
121 kB 190
Allegato riservato 26 2_10_2date04_2001_en.pdf
MEDDEV - April 2001
108 kB 212
Allegato riservato 25 2_7_4_en.pdf
MEDDEV - December 2010
186 kB 285
Allegato riservato 24 sae_reporting_form_en.pdf
MEDDEV - May 2015
20 kB 265
Allegato riservato 23_0 2_7_1_rev_3_2015_en.pdf
MEDDEV - May 2015
383 kB 271
Allegato riservato 23 2_7_2_rev2_en.pdf
MEDDEV - September 2015
413 kB 237
Allegato riservato 22 cetf_en.pdf
MEDDEV - December 2008
99 kB 242
Allegato riservato 21 2_7_1_rev4_en.pdf
MEDDEV - June 2016
627 kB 426
Allegato riservato 20 2_5_10_ol_en.pdf
MEDDEV - January 2012
83 kB 211
Allegato riservato 19 2_5_9rev_latex_en.pdf
MEDDEV - February 2004
96 kB 210
Allegato riservato 18 2_5-7____07-1998_en.pdf
MEDDEV - July 1998
92 kB 193
Allegato riservato 17 2_5-6____02-1998_en.pdf
MEDDEV - February 1998
12 kB 203
Allegato riservato 16 2_5-5____02-1998_en.pdf
MEDDEV - February 1998
10 kB 203
Allegato riservato 15 2_5-3____06-1998_en.pdf
MEDDEV - June 1998
11 kB 199
Allegato riservato 14 ghtf-sg4-n84-2010-guidelines-for-auditing-qms-part-5-control-of-suppliers-100827.pdf
GHTF - Part. 5 August 2012
101 kB 228
Allegato riservato 13 ghtf-sg4-n83-2010-guidelines-for-auditing-qms-part-4-multiple-sites-100827.pdf
GHTF - Part. 4 August 2010
161 kB 232
Allegato riservato 12 2_4_1_rev_9_classification_en.pdf
MEDDEV - June 2010
760 kB 430
Allegato riservato 11 2_2_4_ol_en.pdf
MEDDEV - January 2012
39 kB 257
Allegato riservato 10 2_2-3___06-1998_en.pdf
MEDDEV - June 1998
19 kB 222
Allegato riservato 09 2_2-1____02-1998_en.pdf
MEDDEV - February 1998
19 kB 214
Allegato riservato 08 2_1_6_072016_en.pdf
MEDDEV - July 2016
516 kB 386
Allegato riservato 07 2_1_5____06-1998_en.pdf
MEDDEV - June 1998
13 kB 216
Allegato riservato 06 interpretative_ppe_2009_en.pdf
MEDDEV - August 2009
31 kB 210
Allegato riservato 05 2_1_4____03-1994_en.pdf
MEDDEV - March 1994
23 kB 258
Allegato riservato 04 2_1_3_rev_3-12_2009_en.pdf
MEDDEV - December 2009
183 kB 269
Allegato riservato 03 2_1_2-1__02-1998_en.pdf
MEDDEV - February 1998
15 kB 222
Allegato riservato 02 2_1-2___04-1994_en.pdf
MEDDEV - April 1994
17 kB 232
Allegato riservato 01 2_1-1___04-1994_en.pdf
MEDDEV - April 1994
21 kB 290
Allegato riservato List of Giudance MEDDEVs Update Agosto 2016.pdf
Certifico Srl - Agosto 2016
13324 kB 145
Allegato riservato List of Giudance MEDDEVs Update Novembre 2015.pdf
Certifico Srl - Novembre 2015
12986 kB 239
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Scarica questo file (0. Raccolta linee guida MEDDEV e MDCG Indice 26.02.2024.pdf)0. Raccolta linee guida MEDDEV e MDCG Indice 26.02.2024
Certifico Srl - Rev. 34.0 Febbraio 2024
IT242 kB179
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Certifico Srl - Rev. 33.0 2023
IT231 kB373
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Certifico Srl - Rev. 32.0 2023
IT225 kB516
Scarica questo file (0. Raccolta linee guida MEDDEV e MDCG Indice 07.09.2022.pdf)0. Raccolta linee guida MEDDEV e MDCG Indice 07.09.2022
Certifico Srl - Rev. 31.0 2022
IT217 kB187
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EN565 kB183

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