In Vitro Diagnostic Medical Device Regulation (IVDR)

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.

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.

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.

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.

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.

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.

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.

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.

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).

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.

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).

Documents required for conducting the assessment procedure (e.g. technical documentation) must be submitted in either German or English. An arrangement is needed prior to commencing the certification process, for customers to submit the documents in another official language of the European Union.