References
Medical Device Regulation (EU) 2017/745 Voluntary Change of Notified Body
pdf0.28
Medical Device Regulation (EU) 2017/745 Annex IX Section 5 Specific Procedures
pdf0.3
Medical Device Regulation (EU) 2017/745 Annex IX Section 4 & 5
pdf0.29
Medical Device Regulation (EU) 2017/745 Annex IX and XI Part A
pdf0.47
MDR Conformity Assessment Process Explained
pdf0.47
Medical Device Questionnaire
pdf0.42
Notified Body Managers' Declaration of Interest
pdf0.09
SGS MDR Transition Plan Template
pdf0.18
Transition Guidance for SGS Customers
pdf0.42
SGS Post Market Clinical Follow Plan Template
pdf0.67
MDR Client Technical Documentation Submission Checklist
pdf0.84
Product Medical Device Questionnaire
pdf0.5
Public Prices
pdf0.15
External Documents
Implementation Model for Medical Devices Regulation
pdf0.1
Implementation for Medical Devices Regulation (Focus on Manufacturer’s obligations)
pdf0.6
Implementation Model for In-Vitro Diagnostic Medical Devices Regulation
pdf0.1
MDR IVDR Infographic
pdf0.54
Factsheet for Manufacturers of Medical Devices
pdf0.32
Factsheet for Manufacturers of In Vitro Diagnostic Medical Devices
pdf0.34
Factsheet - Medical Devices and in vitro Diagnostic Medical Devices (For Authorised Representatives, Importers and Distributors)
pdf0.32
Factsheet on Medical Devices and in vitro Diagnostic Medical Devices (For non-EU/EEA States)
pdf0.33
Transition Timelines from the Directives to the Regulations
pdf0.53
EUDAMED - Actor Registration Factsheet
pdf1.31
Guidance for Actor Registration Module in EUDAMED (V1 -Sept. 2020)
pdf2.81
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