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2024.07.30_COM_Draft_QA_document_on_practical_aspects_related_to_the_implementation_of_the_obligations_outlined_in_Article_10a_MDR_and_IVDR_.pdf
- 1 - Draft August 2024 PEXTENSION OF THE MDR 1 2 3 4 5 THE INFORMATION OBLIGATION IN CASE OF INTERRUPTION OR 6 DISCONTINUTION OF SUPPLY OF CERTAIN MEDICAL DEVICES AND IN 7
01.12.2025 Datei PD
2024.08.12_HELSINKI_SUMMARY_Redacted_-_CA_Enquiry_-_Microabrasion_Dental_Stain_Removers__002_.pdf
1 SUMMARY OF ENQUIRY TO MEDICAL DEVICE COMPETENT AUTHORITIES Helsinki Procedure 2021 Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR) Confidential between Member States
01.12.2025 Datei PD
2024.08_ABHS_N_773_Snapshot.pdf
ABHS N 773 SNAPSHOT Medical Devices – List of European Standards intended to be cited in the Official Journal of the European Union (OJEU) under the Directives: • on Medical De
01.12.2025 Datei PD
2024.08.01_REPORTING_FEEDBACK_FORM_Playground_3.9.docx
Reporting Feedback on EUDAMED Playground, v3.9.0 July 2024 REPORTING FEEDBACK FORM This is a Reporting Feedback Form provided to EUDAMED Stakeholders and CAs to report their testing following the la
01.12.2025 Datei PD
2024_06_14_RefE_Gesundes_Herz_Gesetz_GHG.pdf
Bearbeitungsstand: 14.06.2024 13:06 Referentenentwurf des Bundesministeriums für Gesundheit Entwurf eines Gesetzes zur Stärkung der Herzgesundheit (Gesundes- Herz-Gesetz – GHG) A. Problem
01.12.2025 Datei PD
2024.09.12_COM_Draft_Q_A_document_on_practical_aspects_related_to_the_implementation_of_the_obligations_outlined_in_Article_10a_MDR-IVDR__V3.pdf
- 1 - Draft September 2024 PEXTENSION OF THE MDR 1 2 3 4 5 THE INFORMATION OBLIGATION IN CASE OF INTERRUPTION OR 6 DISCONTINUTION OF SUPPLY OF CERTAIN MEDICAL DEVICES AND I
01.12.2025 Datei PD
2024.09.03_COM_Draft_Guidance_on_Master_UDI-DI_for_contact_lenses_v1_v3.1_tc.pdf
MDCG 2024-XX Guidance on the implementation of the Master UDI-DI solution for contact lenses XX 2024 Draft 3.1_Rev. 30-8-2024 This document has been endorsed
01.12.2025 Datei PD
2024.09.03_COM_Draft_Guidance_on_Master_UDI-DI_for_contact_lenses_v3.1_clean.pdf
MDCG 2024-XX Guidance on the implementation of the Master UDI-DI solution for contact lenses XX 2024 Draft 3.1_Rev. 30-8-2024 This document has been endorsed
01.12.2025 Datei PD
2024.09.11_Team-NB-PositionPaper-IVD-Transfer-Agreement.pdf
The European Association of Medical devices Notified Bodies Team-NB Position Paper TEAM-NB Team-NB-PositionPaper-IVD-Transfer-Agreement-20240911.docx Page 1/12 Editor : T
01.12.2025 Datei PD
2024.09.18_COM_Revision_5_MDCG_2019-6_-_part_B_structured_dialogue_reworked_For_consultation_with_stakeholders.pdf
1 First set of updated/additional questions proposed for 1 Revision n.5 of MDCG 2019-6 – Part B (Structured dialogue) 2 3 Revision table 4 MDCG 2019-6 revision 5 changes I.5. Previous
01.12.2025 Datei PD
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