MDCG IRÁNYELVEK
MDCG 2021-
- MDCG 2021-1 – Guidance on harmonised administrative practices and alternative technical solutions until EUDAMED is fully functional
- 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 according to Regulation (EU) 2017/746
- 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 the impact of genetic variants on SARS-COV-2 in vitro diagnostic medical devices
- MDCG 2021-8 – Clinical investigation application/notification documents
- MDCG 2021-9 – MDCG Position Paper on the Implementation of UDI requirements for contact lenses, spectacle frames, spectacle lenses & ready readers
- 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 of actors other than manufacturers, authorised representatives and importers subject to the obligations of Article 31 MDR and Article 28 IVDR
- MDCG 2021-14 – Explanatory note on IVDR codes
- MDCG 2021-15 – Application form to be submitted by a conformity assessment body when applying for designation as notified body under Regulation (EU) 2017/745 on medical devices (MDR)
- MDCG 2021-16 – Application form to be submitted by a conformity assessment body when applying for designation as notified body under Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR)
- MDCG 2021- 17 – Applied-for scope of designation and notification of a conformity assessment body – Regulation (EU) 2017/745 (MDR)
- MDCG 2021- 18 – Applied-for scope of designation and notification of a conformity assessment body – 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 2021-26 – Q and A on repacking & relabelling activities under Article 16 of Regulation (EU) 2017/745 and (EU) 2017/746
MDCG 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 with regard to devices covered by certificates according to MDD or AIMDD
- MDCG 2020-4 – Guidance on temporary extraordinary measures related to medical device Notified Body audits during COVID-19 quarantine orders and travel restrictions
- MDCG 2020-5 – Clinical Evaluation – Equivalence. 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
- 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 – 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 (EU) 920/2013
- 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
- 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 carried out under the Medical Devices Regulation (MDR)/In Vitro Diagnostic medical devices Regulation (IVDR)
- 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 2020-16 – Guidance on 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 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 745/2017
- 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 – Questions and answers: Requirements relating to notified bodies
- 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)
- 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
- MDCG 2019-9 – Summary of safety and clinical performance. A guide for manufacturers and notified bodies
- MDCG 2019-10 – Application of transitional provisions concerning validity of certificates issued in accordance to Directives 90/385/EEC and 93/42/EEC
- MDCG 2019-11 – Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR
- MDCG 2019-12 – pending…
- 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 2019-14 – 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
Kötelező érvényű dokumentumok:
- 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