The many changes to IVD regulations
There has been a comprehensive upgrade in European medical device legislation for in vitro diagnostics that reflects the technological advances that have been made since the industry’s previous regulations were introduced more than 20 years ago.
The new In Vitro Diagnostic Medical Device Regulation (IVDR) is not just a little update but widely increases the scope of compliance and is 4 times longer than the directive it replaces. Full compliance is required by 2022 and some of its key changes are highlighted here.
The IVDR has introduced new classification rules for IVDs according to risk, from the lowest in Class A through to the highest in Class D. The IVDR also defines more types of IVDs as higher risk, which is a significant change as anything above Class A requires review by independent certification organisations (Notified Bodies) to obtain the CE mark instead of via simple self-assessment.
It has been estimated that more than 80% of all IVDs will require conformity assessments by a Notified Body under the new IVDR, instead of the ~20% currently, and so an increased regulatory burden has been imposed on IVD developers, comprised of the creation and maintenance of an auditable Quality Management System (QMS) and the composition and update of multiple new documents.
More rigorous clinical evidence and documentation is required, and manufacturers are asked to conduct clinical performance studies to provide data related to the safety, performance, and also the ‘scientific validity’ of the device. The requirements for performance testing of in vitro diagnostic medical devices are more complex than for most medical devices as the results of the tests must demonstrate that the test is necessary for a medical decision to be made in the indication for which the device is intended.
Documents will also need to be updated based on increased requirements for the reporting of post-market surveillance data. New clinical investigation databases have also been introduced that will form part of a system allowing transparent access to the latest reports on medical devices for sale in Europe to everyone, from regulators, Notified Bodies, other medical device companies and directly to the end users, the healthcare providers and patients themselves.
In Vitro Diagnostic Medical Device Regulation: Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (Text with EEA relevance.) Available online (Accessed 04 February 2020)
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