Linee guida MEDDEV MDCG Dispositivi medici | Aprile 2020
Update Rev. 19.0 April 2020 (26.04.2020)
Allegate tutte le Linee guida ufficiali sui Dispositivi medici in accordo con la Direttiva 93/42/CEE e il nuovo Regolamento (UE) 2017/745.
New Rev. 19.0 Aprile 2020:
- MDCG 2020-5 Clinical Evaluation - Equivalence
- 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
- MDCG 2020-7 Post-market clinical follow-up (PMCF) Plan Template
- MDCG 2020-8 Post-market clinical follow-up (PMCF) Evaluation Report Template
Direttiva 93/42/CEE del Consiglio del 14 giugno 1993 concernente i dispositivi medici(*)
(*) Direttiva sostituita dal Regolamento (UE) 2017/745
New regulations
Guidance documents to assist stakeholders in implementing the Medical Devices Regulations.
1. MDCG documents
Current legislation
Guidance documents to assist stakeholders in implementing directives related to medical devices.
...
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.
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Reference
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Title
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Publication date
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| 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 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 |
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 |
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 |
March 2020 |
| 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 |
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MDCG 2019-4
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Timelines for registration of device data elements in EUDAMED
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April 2019
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MDCG 2019-3
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Interpretation of Article 54(2)b Rev.1
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April 2020
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MDCG 2019-2
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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
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Febraury 2019
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MDCG 2019-1
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MDCG guiding principles for issuing entities rules on Basic UDI-DI
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January 2019
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MDCG 2018-1 V3
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Guidance on BASIC UDI-DI and changes to UDI-DI
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March 2020
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MDCG 2018-2
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Future EU medical device nomenclature – Description of requirements
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March 2018
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MDCG 2018-3
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Guidance on UDI for systems and procedure packs
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October 2018
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MDCG 2018-4
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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
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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
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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))
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October 2018 |
| MDCG 2018-8 |
Guidance on content of the certificates, voluntary certificate transfers
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November 2018 |
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