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Raccolta Linee guida MEDDEV Dispositivi medici

ID 2047 | | Visite: 81447 | Guide Nuovo ApproccioPermalink: https://www.certifico.com/id/2047

Raccolta Linee guida MEDDEV Dispositivi medici / Update Marzo 2022

ID 2047 | Update Rev. 28.0 2022 (23.03.2022)

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. 28.0 del 23 Marzo 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

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 2021

In calce all'articolo pdf "List of Guidance MEDDEVs e MDCG Rev. 26.0 Update 15.11.2021" 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 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 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 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
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
for the assessment of the technical documentation

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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