MDCG guidelines 2019-22
MDCG guidelines 2022
- MDCG 2022-1 – Notice to third country manufacturers of SARS-CoV-2 in vitro diagnostic medical devices
- MDCG 2022-2 – Guidance on general principles of clinical evidence for In Vitro Diagnostic medical devices (IVD)
- MDCG 2022-3 – Verification of manufactured class D IVDs by notified bodies
- MDCG 2022-4 – Guidance on appropriate surveillance with regard to devices covered by MDD or AIMDD certificates
- MDCG 2022-5 – Guidance on borderline between medical devices and medicinal products (Regulation (EU) 2017/745)
- MDCG 2022-6 – Guidance on significant changes regarding the transitional provision under Article 110(3) of the IVDR
- MDCG 2022-7- Questions and Answers on the Unique Device Identification
- MDCG 2022-8- Regulation (EU) 2017/746 – application of IVDR requirements to ‘legacy devices’
- MDCG 2022-9- Summary of safety and performance Template
- MDCG 2022-10- Q&A on the interface between Regulation (EU) 536/2014 on clinical trials…
- MDCG 2022-11- Notice to Manufacturers
- MDCG 2022-12- Harmonised admin practices and alternative technical solutions until Eudamed functional (IVDR)
- MDCG 2022-13- Designation, reassessment of CAB and NB
- MDCG 2022-14- Position Paper on Transition to the MDR and IVDR
MDCG guidelines 2021
- MDCG 2021-1 – Guidance on harmonised administrative practices and alternative technical solutions…
- MDCG 2021-2 – Guidance on state of the art of COVID-19 rapid antibody tests
- MDCG 2021-3 – Questions and Answers on Custom-Made Devices
- MDCG 2021-4 – Application of transitional provisions for certification of class D in vitro diagnostic medical devices
- MDCG 2021-5 – Guidance on standardisation for medical devices
- MDCG 2021-6 – Regulation (EU) 2017/745 – Questions & Answers regarding clinical investigation
- MDCG 2021-7 – Notice to manufacturers and authorised representatives on SARS-COV-2 in vitro diagnostic devices
- MDCG 2021-8 – Clinical investigation application/notification documents
- MDCG 2021-9 – MDCG Implementation of UDI requirements for contact lenses, spectacle frames, spectacle lenses…
- MDCG 2021-10 – The status of Appendixes E-I of IMDRF N48 under the EU regulatory framework for medical devices
- MDCG 2021-11 – Guidance on Implant Card – ‘Device types’
- MDCG 2021-12 – FAQ on the European Medical Device Nomenclature (EMDN)
- MDCG 2021-13 – Questions and answers on obligations and related rules for the registration in EUDAMED…
- MDCG 2021-14 – Explanatory note on IVDR codes
- MDCG 2021-15 – Application form to be submitted by a CAB under Regulation (EU) 2017/745 (MDR)
- MDCG 2021-16 – Application form to be submitted by a CAB under Regulation (EU) 2017/746 (IVDR)
- MDCG 2021- 17 – Applied-for scope of designation and notification of a CAB under Regulation (EU) 2017/745 (MDR)
- MDCG 2021- 18 – Applied-for scope of designation and notification of a CAB under Regulation (EU) 2017/746 (IVDR)
- MDCG 2021-19 – Guidance note integration of the UDI within an organisation’s quality management system
- MDCG 2021-20 – Instructions for generating CIV-ID for MDR Clinical Investigations
- MDCG 2021-21 – Guidance on performance evaluation of SARS-CoV-2 in vitro diagnostic medical devices
- MDCG 2021-22 – Clarification on “first certification for that type of device” – Article 48(6) of Regulation (EU) 2017/746
- MDCG 2021-23 – Guidance for NBs, distributors and importers on certification – Article 16(4) of MDR and IVDR
- MDCG 2021-24 – Guidance on classification of medical devices
- MDCG 2021-25 – MDR requirements to ‘legacy devices’ and to devices placed on the market prior to 26/05/2021
- MDCG 2021-26 – Q and A on repacking & relabelling under Article 16 of Regulation (EU) 2017/745 and (EU) 2017/746
- MDCG 2021-27- Questions and Answers on Articles 13 & 14 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746
- MDCG 2021-28- Substantial modification of clinical investigation under Medical Device Regulation
MDCG guidelines 2020
- MDCG 2020-1 – Guidance on Clinical Evaluation (MDR) / Performance Evaluation (IVDR) of Medical Device Software
- MDCG 2020-2 – Class I Transitional provisions under Article 120 (3 and 4) – (MDR)
- MDCG 2020-3 –Guidance on significant changes regarding the transitional provision under Article 120 of the MDR…
- MDCG 2020-4 – Guidance on temporary extraordinary measures related to medical device NB audits during COVID-19 quarantine orders and travel restrictions
- MDCG 2020-5 – Clinical Evaluation – Equivalence. A guide for manufacturers and notified bodies
- MDCG 2020-6 –Clinical evidence needed for medical devices 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
- MDCG 2020-9 – REGULATORY REQUIREMENTS FOR VENTILATORS AND RELATED ACCESSORIES
- MDCG 2020-10 – Safety reporting in clinical investigations of medical devices under the Regulation (EU) 2017/745
- MDCG 2020-11 – Renewal of designation and monitoring of NBs under Directives 90/385/EEC and 93/42/EEC…
- MDCG 2020-12 – Guidance on transitional provisions for consultations of authorities…
- MDCG 2020-13 – Clinical evaluation assessment report template
- MDCG 2020-14 – Guidance for notified bodies on the use of MDSAP audit reports in the context of surveillance audits
- MDCG 2020-15 – Position Paper on the use of the EUDAMED actor registration module and of the SRN
- MDCG 2020-16 – Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746
- MDCG 2020-17 – Questions and Answers related to MDCG 2020-4
- MDCG 2020-18 – MDCG Position Paper on UDI assignment for Spectacle lenses & Ready readers
MDCG guidelines 2019
- 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 (EU) 2017/745
- MDCG 2019-3 – Interpretation of Article 54(2)b
- MDCG 2019-4 – Timelines for registration of device data elements in EUDAMED
- MDCG 2019-5 – Registration of legacy devices in EUDAMED
- MDCG 2019-6 -rev3– Questions and answers: Requirements relating to notified bodies
- MDCG 2019-7 – Guidance on Article 15 of the MDR and IVDR regarding a ‘person responsible for regulatory compliance’ (PRRC)
- MDCG 2019-8 – rev2 – Implant Card relating to the application of Article 18 Regulation (EU) 2017/745
- MDCG 2019-9 – Summary of safety and clinical performance. A guide for manufacturers and notified bodies
- MDCG 2019-10 – Transitional provisions concerning validity of certificates ( Directives 90/385/EEC and 93/42/EEC)
- MDCG 2019-11 – Guidance on Qualification and Classification of Software in MDR and IVDR
- MDCG 2019-12 – Designating authority’s final assessment form: key information
- MDCG 2019-13 – Guidance on sampling of MDR Class IIa / Class IIb and IVDR Class B / Class C devices…
- MDCG 2019-14 – Explanatory note on MDR codes
- MDCG 2019-15 – GUIDANCE NOTES FOR MANUFACTURERS OF CLASS I MEDICAL DEVICES
- MDCG 2019-16 – rev1 – Guidance on Cybersecurity for medical devices
Mandatory documents:
- IAF MD 1: 2018 IAF Kötelező dokumentum a több telephelyű szervezet által üzemeltetett irányítási rendszer ellenőrzésére és tanúsítására
- IAF MD 2: 2017 IAF kötelező dokumentum az irányítási rendszerek akkreditált tanúsításának átadására
- IAF MD 4: 2018 IAF Kötelező dokumentum az információs és kommunikációs technológia (IKT) felhasználására könyvvizsgálati / értékelési célokra
- IAF MD 8: 2020 Az ISO / IEC 17011: 2017 alkalmazása az orvosi eszközök minőségirányítási rendszereinek területén (ISO 13485)
- IAF MD 10: 2013 IAF kötelező dokumentum az ISO / IEC 17021: 2011 szerinti tanúsító testület kompetenciamenedzsmentjének értékelésére
- IAF MD 12: 2016 Több országban tevékenykedő megfelelőségértékelő testületek akkreditációs értékelése
- IAF MD 17: 2019 Tanúi tevékenységek az irányítási rendszerek tanúsító testületeinek akkreditációjára