EU Regulation Medical Device | IVDD | Directive 98/79 EC | What is EU MDR 2017 | IVDR | Lecture-2

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EU Regulation Medical Device | IVDD | Directive 98/79 EC | What is EU MDR 2017 | IVDR | Lecture-2 @ivdmanufacturing7208




The In Vitro-Diagnostic Medical Devices Directive 98/79/EC (IVDD) offered multiple routes to compliance – depending on the specifications and intended purpose of use of your product. The IVDD was superseded by Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) on May 26, 2022.
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IVDD Compliance Process
Appoint your European Authorized Representative
→ Ask for our quotation!
Identify all EU Directives/Regulations applicable to your product (such as environmental regulations etc.)
→ We will assist!
Identify the applicable harmonized standards for your product
→ We will provide a list!
Check your device against the General Safety and Performance Requirements (annex I)
→ We will provide a checklist!
Select and perform the conformity assessment procedure applicable to your product
→ We will guide you through!
Prepare a Technical File and (if applicable) implement a Quality Management System
→ We will assist!
Select a Notified Body (if applicable) and sign your Declaration of Conformity
→ We will provide lists and forms!



List of Queries-
requirements of the European In Vitro Diagnostic Device Regulation (IVDR 2017/746) to obtain and maintain the CE mark for your product. Gain confidence with the IVD classification rules and the conformity assessment route


What is Directive 98/79/EC of the European Parliament and of the Council-IVDD" EU
What is IVDD
What is IVDR
Transition from IVDD to IVDR
Preparation for the In Vitro Diagnostic Regulation IVDR 2017/746
What Are The New EU IVDR Regulations & How Are They Different To IVDD?
Understanding the IN VITRO DIAGNOSTIC REGULATION (IVDR) Everything You Need to Know
What is the benefits of Directive 98/79/EC of the European Parliament and of the Council-IVDD" EU
Directive 98/79/EC of the European Parliament and of the Council-IVDD" EU kya hota hai ?
Directive 98/79/EC of the European Parliament and of the Council-IVDD" EU kya hai ?
Directive 98/79/EC of the European Parliament and of the Council-IVDD" EU kya hai?
Directive 98/79/EC of the European Parliament and of the Council-IVDD" EUGuidelines ?
Directive 98/79/EC of the European Parliament and of the Council-IVDD" EU Labelling Review
What is the EU Medical Devices Regulation (MDR)?
Why has the IVDD has changed?
What Are The New EU IVDR Regulations & How Are They Different To IVDD?#iso9001

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IVD MANUFACTURING
IVD
Manufacturing
QMS


#MDR2017
#production
#diagnostics
#Audit
#medicaldevice
#QMS
#IVDMANUFACTURING
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