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In Vitro Diagnostic Medical Device Regulation (IVDR)

In vitro diagnostic medical devices – IVDR 2017/746 | TÜV Rheinland

Application date of EU IVDR 2017/746

The new regulation on In Vitro Diagnostic Medical Device IVDR 2017/746 EU regulation came into force on 26 May 2017 to replace 98/79/EC (IVDD). A period of five years, until 26 May 2022, has been granted to allow manufacturers of currently CE marked in vitro diagnostic products the time to transition to the revised IVDR requirements. View the official EU regulation document here

Approach IVDR compliance with confidence

Important changes to the current CE IVD regulation | TÜV Rheinland
Important changes from IVDD to the new IVDR

Respected manufacturers of in vitro diagnostic devices value certification as a way to demonstrate their commitment to the highest standards of quality, meet European market requirements and adorn the CE marking.

Manufacturers are facing new requirements under IVDR 2017/746 issued by the European Commission (CE), which include more stringent mandates such as increased accountability, transparency, detailed documentation and regular filings to the new EUDAMED database.

The most significant change is the new product classification system, and the requirement that manufacturers of IVD devices (Class A exempted) must consult a Notified Body for approval.

Successful transition to IVDR compliance requires manufacturers to prepare for reliable documentation of performance, high safety standards and effective risk management, in addition to conducting comprehensive product inspections while on (and prior to entering) the EU markets.

We provide comprehensive services for your initial or transitionary compliance with the new In Vitro Diagnostic Devices Regulation. Our full range of medical testing and certification services enables us to offer you a tailored service suited to your products and needs.

Our application for designation under regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) is pending, and expected to be approved by December 2020.

CONTACT US TO LEARN MORE ABOUT THE SPECIFICS AND TIMING OF IVDR 2017/746, AND HOW IT AFFECTS YOUR BUSINESS.

Preparatory recommendations for the IVDR compliance process

Pre-compliance checks (general recommendation):

  • Classify products
  • Establish working groups to setup UDI numeration strategy
  • Perform gap analysis
  • Close gaps in QMS (special focus on post-market surveillance & risk management)
  • Close gaps in technical documentation (special focus on performance evaluation & clinical evidence)
  • Coordinate with the Notified Body

Our services include auditing, assessment, testing, inspection, and issuance of regulatory documentation. We inform you on issues related to transition deadlines relevant to certification and addressing issues related to maintaining uninterrupted compliance status and European market access for your devices.

Gain access to European markets with IVDR compliant products

Securing your product compliance with the new EU regulation is mandatory for CE marking and entry into European markets. CE mark certificates are issued based on a successful conformity assessment, and shows your commitment to excellence and fulfillment of European market requirements to authorities and customers.

The CE mark on your in vitro diagnostic device can also increase your competitiveness on the global market beyond EU nations. Our customers enjoy a single-source provider experience from around the world, and have access our network of highly qualified medical device experts sitting locally in major markets.

Your globally recognized and trusted IVDR partner

Our global network of regulatory experts excel in conducting assessments according to the new IVDR requirements. Our reputation for excellence reflects our near 150 years of experience serving a diverse range of industries and customers.

We pride ourselves in delivering high-quality tailored services from a single source to save you time, money and provide the evaluations you need to succeed in the competitive international medical device market.

Complete the IVDR compliance process and maximize market access opportunities with confidence through a single source provider.

FAQ’s on IVDR

Questions and Answers on the new European In Vitro Diagnostic Medical Devices Regulation (MDR 2017/746)

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When does IVDR go into effect?

IVD manufacturers marketing devices in Europe have until 26 May 2022 to comply with IVDR requirements. Additional transitional provisions including extended timelines are defined for specific cases.

How long can products with IVDD 98/79/EC certificates be sold?

In some cases, in vitro diagnostic products already certified by a Notified Body (NB) under IVDD may be sold until May 2024, so long as no significant changes are made to the device, the IVDD certificate is still valid and the device remains subject to regular NB surveillance.

What makes the IVDR 2017/746 different from the previous IVDD 98/79/EC regulation?

EU IVDR 2017/746 implements significant changes including:

  • A life cycle approach requiring effective manufacturer quality management systems to ensure more thorough and transparent maintenance accompanied by living documentation to prove post-market performance.
  • New classification criteria using a rule-based system categorizing products into four risk classes, ranging from Class A (lowest risk) to Class D (highest risk).

Notified Body review mandating products in Class A-Sterile and Class B or higher to be approved for CE marking by a separate authorized entity or Notified Body overseen by a competent authority to eliminate individual interpretation of the requirements.

How are IVD products classified according to IVDR?

The IVDR uses a risk-based classification system with classes ranging from A (the lowest risk) to D (the highest risk). Under IVDR requirements, a Notified Body must inspect Class A-Sterile as well as Classes B, C, and D products.

Does IVDR allow me to self-certify my devices?

With the exception of devices sold in a sterile state, most Class A devices can be self-certified. Class B, C, and D devices require conformity assessments to be performed by an IVDR designated Notified Body.

What is EUDAMED?

EUDAMED is a monitored central database in which manufacturers, operators, products, vigilance reporting and performance studies are registered. It is a mandatory component in accordance with the new IVDR requirements.

What is unique device identification (UDI)?

IVDR mandates manufacturers to implement a globally accepted EU device identification and coding standard (UDI system). The UDI identifies a specific medical device on the market and is used when registering a product into the EUDAMED database.

What is the Basic UDI-DI?

The Basic UDI-DI is the access code for device-related information (the Basic UDI is part of the registered UDI). Referenced on technical documentation, the Declaration of Conformity and the Notified Body of Certification, the Basic UDI-DI identifies devices with the same intended purpose, risk class, essential design and manufacturing characteristics.

What is living documentation?

Living documentation consists of continually updated reports which validate the quality and safety of the in vitro diagnostic medical device. Such documentation includes performance evaluation and risk management as well as post-market surveillance (PMS), or periodic safety update reports (PSUR).

Why is performance evaluation important under the new IVDR?

The IVDR certification obligates continuous performance evaluations to provide sufficient clinical evidence and documented proof, that a device is safe and will deliver the intended clinical benefits.

What is post-market surveillance?

Data collected from post-market surveillance (PMS) and performance follow-up (PMPF) is consistently reported to monitor risk management, performance standards and practices. Under IVDR, manufacturers are required to submit documentation such as the Post-Market Surveillance plan (PMS) and corresponding reports, in addition to periodic safety update reports (PSUR).

More information on IVDR

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

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