EU Regulation|Directive 98/79/EC of the European Parliament and Council|In-Vitro Medical Device|L-1

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EU Regulation|Directive 98/79/EC of the European Parliament and Council|In-Vitro Medical Device|L-1@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 The IVDD was superseded by Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) on May 26, 2022.

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 harmoized 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!
Article-1 Scope & Definition
This Directive shall apply to in vitro diagnostic medical devices
and their accessories. For the purposes of this Directive, accessories
shall be treated as in vitro diagnostic medical devices in their own
right. Both in vitro diagnostic medical devices and accessories shall
hereinafter be termed devices


in vitro diagnostic medical device’ means any medical device
which is a reagent, reagent product, calibrator, control material,
kit, instrument, apparatus, equipment, or system, whether used
alone or in combination, intended by the manufacturer to be
used in vitro for the examination of specimens, including blood
and tissue donations, derived from the human body, solely or
principally for the purpose of providing information:
— concerning a physiological or pathological state, or
— concerning a congenital abnormality, or
— to determine the safety and compatibility with potential recipients,
or
— to monitor therapeutic measures.

Article2-Placing on the market and putting into service
Member States shall take all necessary steps to ensure that devices may
be placed on the market and/or put into service only if they comply with
the requirements laid down in this Directive when duly supplied and
properly installed, maintained and used in accordance with their
intended purpose

Article 3 Essential requirements
Devices must meet the essential requirements set out in Annex I which
apply to them, taking account of the intended purpose of the devices
concerned.

Article 4 Free Movement
Member States shall not create any obstacle to the placing on the
market or the putting into service within their territory of devices
bearing the CE marking provided for in Article 16 if these devices
have undergone conformity assessment in accordance with Article 9.

Member States may require the information to be supplied
pursuant to Annex I, part B, section 8 to be in their

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

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