TOPIC
Title
Author
MD Manufacturers
Factsheet for Manufacturers of Medical Devices
EC
Implementation Model for Medical Devices Regulation Step by Step Guide
MDCG 2019-15 GUIDANCE NOTES FOR MANUFACTURERS OF CLASS I MEDICAL DEVICES
IVD Manufacturers step by step
Implementation Model for In-Vitro Diagnostic Medical Devices Regulation Step by Step Guide
European Medical Device Nomenclature (EMDN)
The European Medical Device Nomenclature (EMDN) – the nomenclature of use in EUDAMED
The CND Nomenclature
UDI
Unique Device Identification (UDI) System – FAQs
MDCG 2018-1 v3 Guidance on BASIC UDI-DI and changes to UDI-DI
MDCG 2019-1 MDCG guiding principles for issuing entities rules on Basic UDI-DI
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
MDCG 2018-2 Future EU medical device nomenclature – Description of requirements
MDCG 2018-4 Annex: UDI database Definitions/Descriptions and formats of the UDI core elements for systems or procedure packs
MDCG 2018-5 UDI Assignment to Medical Device Software
MDCG 2018-6 Clarifications of UDI related responsibilities in relation to Article 16 of the Medical Device Regulation 2017/745 and the In-Vitro Diagnostic Medical Devices Regulation 2017/746
MDCG 2018-7 Provisional considerations regarding the language issues associated with the UDI database (Annex VI, Part A Section 2 and Part B of the Medical Devices Regulation 2017/745 and the In-Vitro Diagnostic Medical Device Regulation 2017/745
Guidance on UDI for systems and procedure packs – MDCG 2018-3 Rev.1
EUDAMED
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 2019-4 Timelines for registration of device data elements in EUDAMED
MDCG 2019-5 Registration of legacy devices in EUDAMED
ART 15 PRRC
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)
ART 18 Implant Card
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
ART 54
MDCG 2019-3 Interpretation of Article 54(2)b rev 1
ART 120 Transitional provisions
MDCG 2020-2 Class I Transitional provisions under Article 120 (3 and 4) – (MDR)
MDR FAQ
CAMD Transition Sub Group FAQ – MDR Transitional provisions
Notified Body
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 2020-12 Transitional provisions for consultations of authorities on devices incorporating a substance which may be considered a medicinal product […] as well as on devices manufactured using TSE susceptible animal tissues
MDCG 2020-11 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
MDCG 2020-4 Guidance on temporary extraordinary measures related to medical device Notified Body audits during COVID-19 quarantine orders and travel restrictions
MDCG 2020-3 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
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
MDCG 2019-12 Designating authority’s final assessment form: Key Information (EN)
MDCG 2019-10 Application of transitional provisions concerning validity of certificates issued in accordance to Directives 90/385/EEC and 93/42/EEC
MDCG 2019-6 v2 Questions and answers: Requirements relating to notified bodies
Guidance on Content of the certificates, voluntary certificate transfers
Cybersecurity
MDCG 2019-16 – Guidande on Cybersecurity for medical devices
Clinical Investigation and Evaluation
MDCG 2020-13 Clinical evaluation assessment report template
MDCG 2020-10/1 Safety reporting in clinical investigations of medical devices under the Regulation (EU) 2017/745
MDCG 2020-10/2 Clinical Investigation Summary Safety Report Form v1.0
MDCG 2020-8 Post-market clinical follow-up (PMCF) Evaluation Report Template. A guide for manufacturers and notified bodies
MDCG 2020-7 Post-market clinical follow-up (PMCF) Plan Template. A guide for manufacturers and notified bodies
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. A guide for manufacturers and notified bodies
MDCG 2020-5 Clinical Evaluation – Equivalence. A guide for manufacturers and notified bodies
MDCG 2020-1 Guidance on Clinical Evaluation (MDR) / Performance Evaluation (IVDR) of Medical Device Software
MDCG 2019-9 Summary of safety and clinical performance A guide for manufacturers and notified bodies – August 2019
Surveillance & Vigilance
Manufacturer incident report 2020
Software
Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR
Other documents
MDCG 2020-9 Regulatory Requirements for Ventilators and Related Accessories
Guidelines on the benefit-risk assessment of the presence of phthalates in certain medical devices covering phthalates which are carcinogenic, mutagenic, toxic to reproduction (CMR) or have endocrine-disrupting (ED) properties
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