Die MDCG (Medical Device Coordination Group) veröffentlicht regelmäßig sehr hilfreiche Dokumente, die Benannten Stellen, Behörden und Hersteller*innen helfen, die Anforderungen der MDR (Medical Device Regulation) richtig zu interpretieren.
Im Folgenden finden Sie eine Aufstellung der insgesamt 28 Guidance-Dokumente der MDCG des vergangenen Jahres.
Unsere Expert*innen empfehlen einen Blick in diese zu werfen:
- MDCG2021-28 Substantial modification of clinical investigation under Medical Device Regulation
- MDCG2021-27 Questions and Answers on Articles 13 & 14 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746
- MDCG2021-26 Questions and Answers on repackaging & relabelling activities under Article 16 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746
- MDCG2021-25 Regulation (EU) 2017/745 – application of MDR requirements to ‘legacy devices’ and to devices placed on the market prior to 26 May 2021 in accordance with Directives 90/385/EEC or 93/42/EEC
- MDCG2021-24 Guidance on classification of medical devices
- MDCG2021-23 Guidance for notified bodies, distributors and importers on certification activities in accordance with Article 16(4) of Regulation (EU) 2017/745 and Regulation (EU) 2017/746
- MDCG2021-22 Clarification on “first certification for that type of device” and corresponding procedures to be followed by notified bodies, in context of the consultation of the expert panel referred to in Article 48(6) of Regulation (EU) 2017/746
- MDCG2021-21 Guidance on performance evaluation of SARS-CoV-2 in vitro diagnostic medical devices
- MDCG2021-20 Instructions for generating CIV-ID for MDR Clinical Investigations
- MDCG2021-19 Guidance note integration of the UDI within an organisation’s quality management system
- MDCG2021-18 Applied-for scope of designation and notification of a conformity assessment body – Regulation (EU) 2017/746 (IVDR)
- MDCG2021-17 Applied-for scope of designation and notification of a conformity assessment body – Regulation (EU) 2017/745 (MDR)
- MDCG2021-16 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)
- MDCG2021-15 Application form to be submitted by a conformity assessment body when applying for designation as notified body under the MDR
- MDCG2021-14 Explanatory note on IVDR codes
- MDCG2021-13 Rev. 1 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
- MDCG2021-12 FAQ on the European Medical Device Nomenclature (EMDN)
- MDCG2021-11 Guidance on Implant Card – ‘Device types’
- MDCG2021-10 The status of Appendixes E-I of IMDRF N48 under the EU regulatory framework for medical devices
- MDCG2021-9 MDCG Position Paper on the Implementation of UDI requirements for contact lenses, spectacle frames, spectacle lenses & ready readers
- MDCG2021-8 Clinical investigation application/notification documents
- MDCG2021-7 Notice to manufacturers and authorised representatives on the impact of genetic variants on SARS-COV-2 in vitro diagnostic medical devices
- MDCG2021-6 Regulation (EU) 2017/745 – Questions & Answers regarding clinical investigation
- MDCG2021-5 Guidance on standardisation for medical devices
- MDCG2021-4 Application of transitional provisions for certification of class D in vitro diagnostic medical devices according to Regulation (EU) 2017/746
- MDCG2021-3 Questions and Answers on Custom-Made Devices & considerations on Adaptable medical devices and Patient-matched medical devices
- MDCG2021-2 Guidance on state of the art of COVID-19 rapid antibody tests
- MDCG2021-1 Rev. 1 Guidance on harmonised administrative practices and alternative technical solutions until EUDAMED is fully functional
Weitere Informationen finden Sie auf den Seiten der Europäischen Kommission.
Sprechen Sei uns an, wenn Sie Fragen zu den einzelnen Themen der MDCG haben oder Unterstützung in der Umsetzung benötigen. Wir helfen Ihnen gerne weiter!
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