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
21.05.2024
Datei
PD
Preliminary re-assessment review template[footnoteRef:1] - MDR (Regulation (EU) 2017/745) [1: This form will be used to document the DA’s review of the NB’s documentation for re-assessment. This docu
21.05.2024
Datei
PD
Preliminary re-assessment review template[footnoteRef:1] - IVDR (Regulation (EU) 2017/746) [1: This form will be used to document the DA’s review of the NB’s documentation for re-assessment. This doc
21.05.2024
Datei
PD
Attachment to the letter of the Ministry of Health of Ukraine
Name Need
Medicines (Ліки)
Means for parenteral nutrition, solution of amino acids bottles 15 000
Alteplase 2 000
Albumin
21.05.2024
Datei
PD
Coverage of designation codes
by MDR/IVDR notified bodies
January 2023
Summary MDR codes coverage
More than 80% of codes are covered by more than 20/36
NBs
Just 5 codes are covered by less
21.05.2024
Datei
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
21.05.2024
Datei
PD
1
Overview of CAB/NBs at each stage of the designation process
(7 February 2023)
63
57
52
46 43
38 38 38 37 37
19
17
15
13
12
10 10 10 10 8
0
10
20
30
40
50
60
70
80
90
Application
21.05.2024
Datei
PD
Safe and Sustainable by Design
chemicals and materials
Application of the SSbD
framework to case studies
DRAFT FOR CONSULTATION
Caldeira, C., Garmendia Aguirre, I., Tosches, D.,
Farcal, R.,
21.05.2024
Datei
PD
EN EN
EUROPEAN
COMMISSION
Brussels, XXX
SANTE/12523/2015 CIS
(POOL/E2/2015/12523/12523-EN
CIS.docx)
[…](2022) XXX draft
COMMISSION REGULATION (EU) …/…
of XXX
repealing a
21.05.2024
Datei
PD
G
Berlin
Friedrichstraße 134
D-10117 Berlin
T. 030 | 308 75 96 - 0
Bonn
Ubierstraße 71 – 73
D-53173 Bonn
T. 0228 | 957 45 - 0 E-Mail: bah@bah-bonn.de
Stellungnahme
21.05.2024
Datei
PD
