Referenties
MDR Unannounced Audit Questionnaire
pdf0.15
Medical Device Questionnaire
pdf0.6
Medical Device Regulation (EU) 2017/745 Annex IX or XI Part A
pdf0.32
Medical Device Regulation (EU) 2017/745 Annex IX Section 4 and 5
pdf0.22
Medical Device Regulation (EU) 2017/745 Annex IX Section 5 Specific Procedures
pdf0.2
Medical Device Regulation (EU) 2017/745 Article 16
pdf0.27
Medical Device Regulation (EU) 2017/745 Article 117
pdf0.28
Medical Device Regulation (EU) 2017/745 Voluntary Change of Notified Body
pdf0.28
Medical Device Regulation (MDR) Conformity Assessment Explained
pdf0.3
Medical Device Regulation (MDR) Readiness Checklist
pdf0.35
Medical Device Regulation (MDR) Technical Documentation Request Form
pdf0.39
Medical Devices Notification of Changes, Regulatory Action, Consultancy or Services Rendered
pdf0.24
Medical Devices Pre-Audit Client Questionnaire
pdf0.62
Notified Body Managers' Declaration of Interest
pdf1.85
SGS MDR Transition Plan Template
pdf0.18
Product Medical Device Questionnaire
pdf0.78
Public Prices
pdf0.14
Relevant Subcontractors and Suppliers List
pdf0.67
Transition Guidance for SGS Customers
pdf0.42
Externe documenten
EUDAMED - Actor Registration Factsheet
pdf1.31
Factsheet for Manufacturers of In Vitro Diagnostic Medical Devices
pdf0.34
Factsheet for Manufacturers of Medical Devices
pdf0.32
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
Guidance for Actor Registration Module in EUDAMED (V1 -Sept. 2020)
pdf2.81
Implementation for Medical Devices Regulation (Focus on Manufacturer’s obligations)
pdf0.6
Implementation Model for In-Vitro Diagnostic Medical Devices Regulation
pdf0.1
Implementation Model for Medical Devices Regulation
pdf0.1
MDR IVDR Infographic
pdf0.54
Transition Timelines from the Directives to the Regulations
pdf0.53