Deutscher Bundestag Drucksache 20/11561
20. Wahlperiode 29.05.2024
Gesetzentwurf
der Bundesregierung
Entwurf eines Medizinforschungsgesetzes
A. Problem und Ziel
Arzneimittel und Medizinprodukte
08.12.2025
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PD
Medical Devices
Medical Device Coordination Group Document MDCG 2020-16 rev.2
Guidance on Classification Rules for in-vitro Diagnostic Medical Devices for Regulation (EU) 201
08.12.2025
Datei
PD
1
EUROPEAN COMMISSION
DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY
Medical Products and Innovation
Medical Devices
MDR - language requirements for manufacturers Rev. 1 (March 2
08.12.2025
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PD
Work Programme of MDCG Borderline and Classification subgroup 2023
Last update: 21 November 2023
This document sets out the work program of the MDCG B&C Working Group for 2023. There are a number of
08.12.2025
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PD
Medical Device Coordination Group Document MDCG 2024-12
applicable for M
08.12.2025
Datei
PD
EN EN
EUROPEAN
COMMISSION
Brussels, 6.1.2023
COM(2023) 10 final
2023/0005 (COD)
Proposal for a
REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
amending Regulatio
08.12.2025
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PD
Medical Devices
Medical Device Coordination Group Document MDCG 2019-07 Rev 1
Page 1 of 10
MDCG 2019-07 Rev.1
Guidance on Article 15 of the medical device
regulation (MDR) a
08.12.2025
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PD
European
Commission
Q&A on practical aspects related to the implementation of Regulation (EU)
2023/607 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards
the transitional provisio
08.12.2025
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PD
1
Ongoing guidance development and deliverables of MDCG Subgroups – March 2023*
*This is not an exhaustive list of ongoing work performed by MDCG Subgroups
Scope Group Deliverables
Consult
08.12.2025
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PD
(Letter to be printed on the NB Letterhead); It is recommended that a relevant watermark be applied to the letter and the letter issued in a secure pdf format to reduce the risk of falsification/tampe
08.12.2025
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PD
