Changes as a result of the EU regulation on in vitro diagnostic medical devices
In connection with the application of the regulation on in vitro diagnostic medical devices (IVD) on 26 May 2022, a number of new and amended requirements have been introduced for IVDs to be placed on the European market. Read about the ensuing overall changes here.
In line with the constant innovation, the development of technology and the complexity of new IVDs launched, the safety of available IVDs needs to be strengthened further. This is achieved through the new Regulation (EU) 2017/746 on in vitro diagnostic medical devices (the IVD regulation), which increases the requirements for clinical evidence, market surveillance and conformity assessments involving notified bodies.
New requirements and changes to existing requirements of Directive 98/79/EEC meet the need for enhancing patient safety whilst creating an internationally recognised regulatory framework. As the IVD regulation is directly applicable, it does not need to be implemented in national law, which reduces the risk of inconsistent interpretation by the EU markets.
Primary changes in IVD requirements after 26 May 2022
The new regulation introduces a risk-based classification system, according to which devices are classified in four risk classes depending on the intended purpose of the device and the risks associated with using the device. All new IVDs placed on the market must therefore be classified as either risk class A, B, C or D. As a consequence of the new classification rules, some IVDs previously classified as 'general IVDs' will in future be classified as medium or high-risk devices (risk classes B, C and D). Find guidance on classification here.
Conformity assessment procedures
The risk classification governs which conformity assessment procedure the manufacturer can choose, and after 26 May 2022, IVDs belonging to a risk class higher than A must be certified by a notified body in order to receive a CE marking and be placed on the market. This will increase the number of IVDs to be certified by a notified body.
Stricter documentation requirements
The stricter documentation requirements involve a clinical evaluation and a performance evaluation, which in combination must demonstrate that the clinical benefits and safety of the device outweigh any risks of using the device and that the performance of the device meets the intended purpose.
Stricter market surveillance requirements
Market surveillance requirements will be tightened after 26 May 2022, which implies that manufacturers must actively and systematically gather, record and analyse relevant data on the quality, performance and safety of an IVD throughout its entire lifetime. In addition, manufacturers must proactively collect and evaluate performance and scientific data from the use of IVDs.
Article 5(5) exemption, also referred to as 'in-house IVDs'
IVDs manufactured and used only within health institutions are exempt from the requirements of the IVD regulation provided that the devices meet the relevant safety and performance requirements set out in Annex I to the IVD regulation and all the requirements set out in article 5(5) of the regulation.
Additional to the above requirements, new requirements are also introduced for importers and distributors, companion diagnostics, Eudamed, etc.
To address any capacity challenges of the notified bodies, the Commission has decided to introduce a number of transitional provisions under the IVD regulation.
The above extension of the transitional provisions set out in Article 110 of the IVD regulation is meant to ensure that patients continue to have access to safe and effective IVDs.