EU IVDR Application Countdown

Are you ready for the May 2022 deadline?

IVDR Brochure

Starting in May 2022, Europe’s In Vitro Diagnostic Devices Regulation 2017/746 (IVDR) will apply to the world’s second-largest medical device market. This new Regulation will make significant changes to how IVD manufacturers acquire CE Marking and maintain market access in Europe, including a completely revised classification system that will involve Notified Body intervention for many formerly self-certifying devices. The IVD manufacturers must begin planning their regulatory transition strategy to comply with new regulations coming on May 2022. For those manufacturers that need certification by a Notified Body, they need to create a plan well in advance to have enough time for transition period. Bear in mind that consultants, in-house professionals, and Notified Bodies will all get busier as deadline approach.

The obligations of the different actors and their relations compel Manufacturer to have the following:

Risk Management System
Quality Management System (Article 10)
Must Conduct Performance Evaluations (PE) for all Classes
Technical documentation (Annex II) and Technical Documentation on PMS
Declaration of Conformity
Application of Unique Device Identifier [Article 113 (e)]

Manufacturers are responsible and liable for defective devices and must allow access to information for parties to claim compensation.

Every manufacturer shall have a designated Person Responsible for Regulatory Compliance (PRRC) as per Article 15.

Manufacturers outside the EU/EEA shall have an appropriate contract with an authorised representative based inside the EU/ EEA.

Compared to the IVDD, the IVDR places more emphasis on the life-cycle management and continuous evaluation of products. The IVDR requires manufacturers to show that they have an effective quality management system and full assessment of their Quality System by Notified Body and conduct Post Market Surveillance (PMS) activities.

Application of Unique Device Identifiers (UDI) is a requirement under IVDR. The timelines to apply UDI for:

Class D is 26 May 2023.
Class B and C is 26 May 2025
Class A 26 May 2027.

How We Help You

Performing a comprehensive IVDR gap analysis and QMS development and Implementation

Our most senior consultants will perform a systematic, independent gap analysis to assess the areas of your documentation, procedures, and processes

Usability Engineering (UE) Practice

The shift to a lifecycle approach to certification shows that post-market surveillance (PMS) and post-market performance follow-up (PMPF) reports will receive more attention.

As Your Authorized Representative

Do you want to sell your medical device or in vitro diagnostic (IVD) device in Europe and need CE certification?