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IVDR: New EU Regulations for In-Vitro Diagnostic Medical Devices

Services according to the new EU in-vitro diagnostic medical device regulation IVDR | TÜV Rheinland

Application for designation under the Regulation for In-vitro Diagnostics (IVDR) 2017/746

TUV Rheinland Medical

Notified Bodies are allowed to apply first-time since November 26, 2017 for designation under the Regulation for In-vitro Diagnostics (IVDR) 2017/746. We are glad to inform you, that our application is already filed and covers a comparable scope as currently maintained by us.

Enabling compliance with the new EU IVDR (EU) 2017/746

The new EU regulations for in-vitro diagnostics came into force on May 25, 2017. This regulation will replace the directive on in-vitro diagnostic medical devices (IVDD 98/79/EC). The application date of the new IVDR is May 26, 2022. The new rules stipulate more rigorous and comprehensive requirements for CE marking of medical devices in Europe. During the transition period, IVD manufacturers must plan, prepare and implement strategies for compliance, as this regulation is a prerequisite for access to European markets.

With our experience and solid status as a Notified Body under current legislation governing IVDs, we are perfectly positioned to support you in the transition to the new regulation. For over 40 years we have stood for safety and quality in the testing and assessment of medical devices. As an internationally acting Notified Body and certification body, we are renowned experts for global market access. Based on the commitment, expertise and experience of our dedicated staff, we can offer the latest one-stop solutions for you.

Customer Survey for the conversion of your certificates

xlsx Customer survey IVDR 56 KB Download

CE mark for IVD enables your market access to Europe and increases your competitiveness on the global market

Having your in-vitro diagnostic device assessed for compliance with the new EU regulation is mandatory for CE marking and market access within Europe. We issue CE-certificates based on a successful conformity assessment, consolidating and improving your market position. The CE mark indicates to authorities and customers that you are committed to high-quality products and have met the European requirements.

IVD certification and comprehensive IVD services

Important changes of IVDR from the current regulation IVDD

Currently, our services focus on the transition period and the timeline for compliance with IVDR 2017/746. Our experts can assist you in meeting deadlines and addressing all issues relevant to maintaining access for your medical devices to European markets.

We concentrate on supporting you through the transition from IVDD to IVDR. At this stage, we can inform you about the requirements of the IVDR by attending our conferences and seminars which will enable you:

  • to see how your business model and portfolio is affected by the IVDR
  • to establish a transition plan
  • to carry out a gap analysis of products affected
  • to update your quality management system (QMS)

Furthermore, we support IVD manufacturers with additional services such as ISO 13485 certification, MDSAP (Medical Device Single Audit Program) and product testing.

Your ideal partner for medical device regulation

As the leading provider of testing and certification services in the world, we have been assisting our clients with their products for over 140 years, and as one of the biggest Notified Bodies in Europe we represent stability, reliability and the highest quality of service.

Our global network of experts has extensive knowledge and experience in IVD/medical device and QMS certification. With our capacity, reputation, experience, and one-stop-shopping services, we are the partners to trust for customers in the medical device industry.

Contact us to get started.

More information on IVDR

pdf Brochure: Product testing and certification for medical devices 3 MB Download

Related Topics

Our Test Marks for Products

Worldwide Market Access

IVDR Informationen in Deutsch

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