Raccolta Linee guida MEDDEV Dispositivi medici
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Raccolta Linee guida MEDDEV Dispositivi medici
Update Rev. 22.0 Luglio (07.07.2020)
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. 22.0 del 07 Luglio 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
- Manufacturer Incident Report - MIR Version 7.2.1
- MIR and FSCA xml files (FSCA Report - Incident Report) Version 7.2.1
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 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 | 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 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 Ⅰ. MEDDEV 2.12/1 rev.8 – Latest Version Forms Additional Guidance Regarding the Vigilance System as outlined in MEDDEV 2.12-1 rev. 8 Active PDF forms 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 EU Vigilance Pilot on Trending – Additional MIR Form Ⅱ. Device Specific Vigilance 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 | Oggetto | Autore |
| 22.0 | 07 Luglio 2020 |
MDCG 2020-12 |
Certifico Srl |
| 21.0 | 28 Maggio 2020 |
MDCG 2020-11 |
Certifico Srl |
| 20.0 | 29 Aprile 2020 |
MDCG 2020-9 |
Certifico Srl |
| 19.0 | 26 Aprile 2020 |
MDCG 2020-5 |
Certifico Srl |
| 18.0 | 09 Aprile 2020 |
MDCG 2019-3 |
Certifico Srl |
| 17.0 | 18 Marzo 2020 |
MDCG 2020-3 |
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 |
Certifico Srl |
| 13.0 | 30 Novembre 2019 |
Qualification and classification of software 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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