The new In vitro Diagnostics Regulation (IVDR) radically changes requirements for In Vitro Diagnostic Devices (IVD) and represents a major challenge for all parties involved.

PlantVision has an experienced multidisciplinary team, covering a broad range of resources, expertise, and services, who can provide customers with continuous support over the implementation and transition period to IVDR.

IVDR timeline

26 May 2017

IVDR came into force

26 May 2022

Full application of organizational requirements, vigilance, PMS and Eudamed registration, as well as product requirements for Class A and new devices

26 May 2025

Full application of product requirements class D

26 May 2026

Full application of product requirements class C

26 May 2027

Full application of product requirements class B and sterile class A

Legacy devices of class B, C or D may be sold by distributors until one year after application of the IVDR product requirements. IVDD CE-marked class A devices that have been placed on the market before 26 May 2022 may be sold by distributors until 26 May 2025.

Support for transitioning from IVDD to IVDR

Compared to the IVDD, the IVDR has introduced new requirements for all types of IVD products, for quality management systems of manufacturers, for all organizations within the supply chain, and even for hospital laboratories.

Many manufacturers will find themselves confronted with significant gaps in their product documentations and quality management systems, as well as that they will face inspection by a notified body for the first time. Distributors and importers might find themselves in a need of a quality management system, and hospital laboratories will need to identify their so called in-house IVD’s for determining gaps in the documentation for those.

Regardless of your role within the IVD industry, PlantVision can help you on your IVDR journey.

In addition to the services listed below, we offer specific support for companies transitioning to IVDR. For starters, we can help your organization to gain a good understanding of the new regulation and its requirements. This can be achieved through introductory workshops, where we help you to identify your company’s specific needs. Alternatively, you can look out for our PlantVision Academy » courses.

We can also help you to efficiently define your transition plan by carrying out a thorough IVDR gap analysis, providing a detailed follow-up report with recommendations for what actions should be taken. Our consultants have broad industry experience, as well as in-depth knowledge about IVD’s. We can help with risk, quality and regulatory management.

Through both strategy and resources we can help smooth the path to a CE marked product – from requirements, development, documentation and tests, to contacts with Notified bodies and market access.

You can also ensure continuous support through our Compliance Partner service, which provides fast and efficient access to experienced consultants.

Ewa Kloskowska
Ewa KloskowskaHead of Unit, Medtech and IVD
Tel: +46 (0)73-092 01 34

Contact me to find out how we can support your organization, or to arrange an IVDR workshop where we help you identify the specific challenges facing your organization. Please include your contact information in your email (name, job title, company, tel nr, etc.).

How can we support you?

Compliance
Partner

  • Get regulatory support when YOU need it
  • Gain access to a diverse team of regulatory experts
  • Get help with regulatory quesitons or regulatory tasks
  • We provide long-term partnerships that adapt to your needs

Quality Management System

  • Bring your QMS in line with EN ISO13485 and/or FDA requirements
  • We can help you design a new QMS, conduct QMS audits, or carry out QMS gap analyses against IVDR
  • We offer both defined QMS projects and QMS consultants

Technical Documentation

  • Update or create new documentation according to IVDR
  • We provide gap analyses, action lists, documentation planning and report writing
  • We offer customized project packages, as well as project leaders and extra resource consultants

Performance Evaluation

We can provide verification & validation leads as well as support resources for…

  • Compiling PE plans and reports
  • Systematic literature reviews and writing of scientific validity reports
  • Planning and performing analytical performance studies
  • Evaluation of clinical data and planning scope of clinical studies