IVDR Part II – Your Technical Documentation and Performance Evaluation
In the previous article we had discussed some of the major changes to be considered in the EU IVDR; namely increased regulatory oversight, expanded clinical evidence requirements, greater requirements for IVD manufacturers and intensified supervision of Notified Bodies.
This article drills further down into the new nomenclature of IVDR devices, stressing the components of Technical documentation, and performance evaluation that are paramount to conformity.
EU IVDR – Expanded Product Scope
An understanding of the new nomenclature, intended use and indications of use included in the scope of the IVDR are crucial first steps to achieving compliance.
Self-testing devices which were previously defined for use in the “home environment”, have been redefined as “to be used by laypersons”; such that a test done by a patient will be considered self-testing, regardless of the location. Now, self-testing devices and near- patient, testing devices will be required to undergo a premarket approval approach.
The concept of single use devices intended to be used during a single procedure, which were part of the MDD, have been introduced in the IVDR as well. Since this information must be mentioned on the label, in the Instructions for Use (IFU), and in the registration information for the IVD’s UDI, this affects user information and registration of the device.
Companion diagnostics, which are essential for the safe and effective use of a medicinal product, must abide by the general safety and performance requirements of the MDR. However, in case the device is marketed as a single, non-reusable product, not intended to be used alone, except in the given combination, the combination product is regulated under the medicinal products framework. Also, in the event that the medical device and the medicinal product are not physically combined, the device will need to be CE marked.
Kit has been defined as a set of components packaged together and intended to be used to perform a specific examination or a part thereof. This definition will help determine borderline cases where devices work together in an IVD procedure.
Stressing the importance of Technical Documentation on the path to Conformity
In accordance with the IVDR, the key components of Technical Documentation which are expected to play quite a significant role in the conformity route are as follows:
- Device Description and Specification
- Information Design and Manufacturing
- General Safety and Performance Requirements (GSPR)
- Benefit-Risk Analysis and Risk Management
- Product Verification and Validation
Full disclosure on Medical Device Design, Production and Quality Testing
Beginning with an explanation on what the device is, its intended use and technical specifications, the technical documentation also covers more complex information such as design and manufacturing details allowing readers to understand the intricacies of production, assembly, final product testing and packaging.
Higher Emphasis on Risk Management Strategy
The IVDR is quite similar to ISO 14971:2012 in that it lays greater emphasis on identification of risks such as foreseeable product misuse and mitigation. There is a preference for design changes to eliminate risks, as far as possible (Design control) and to include proper communication of any residual risks to the user through the IFU, . The benefit/risk ratio here implies the control of risks such that the benefits that outweigh any remaining risk. The IVDR recommends that Risk Management should align with the Performance Evaluation.
Maintaining Continuity on Performance Evaluation Reports (PER)
In contrast to the IVDD, the IVDR aims to bring a paradigm change by the inclusion of an essential requirement to demonstrate performance, labelling requirements, and the requirement for the Technical Documentation to contain adequate performance evaluation data. The IVDR clarifies that the objective of Performance evaluation is to provide “clinical evidence” that supports the manufacturer’s intended use, and not merely the analytical performance claims.
Verification & validation are fundamental requirements for the conformity of any IVD device. In the pre-market phase, Performance evaluation is described as a three-step process: (1) planning the evaluation, (2) collecting the clinical evidence based on data that shows the scientific validity andthe analytical and clinical performance, (3) assessing and reporting on the data which has been collected resulting in the PER. Performance evaluation is now a lifecycle activity, with updates from scientific or medical practice and subsequent reassessments.
Strong Post-Market Performance Follow-up (PMPF) Plan
In this phase, the manufacturer is required to continuously review the PER to ensure it reflects the state of the art. In accordance with the IVDR, every manufacturer must have a PMPF Plan, and produce a PMPF Evaluation Report. The IVDR details the new PMPF requirements, including the dependency on the type and classification of the device being reviewed and how it should be defined within a Quality Management System (QMS).
The Post Market Performance Follow-up (PMPF) is an important element of Post Market Surveillance (PMS). Other aspects such as Risk Management, Corrective and Preventive Actions (CAPA), Safety Monitoring should all be linked through the Post Market Surveillance (PMS) plan with the PER. The post-market data will be only as effective as the continuous process for locating, aggregating and analyzing it.
Did you know?
- Although medical devices or components integrated into the medical device will need to comply with the MDR, an IVD component in the medical device must be certified in accordance with the IVDR. For example, this could result in a Class I medical device consisting of a Class D IVD that must obtain certification from a NB.
- It is up to the Member states to restrict the distribution of certain IVDs to specific groups of professionals, for example some Member States may limit the use of Class D IVDs to healthcare professionals only.
The IVDR will bring about an enormous change to the IVD industry due to the arduous requirements which will undoubtedly result in a huge amount of work if appropriate procedures are not developed. The evolution of the IVDR in the coming years will change expectations and lead to an inevitable rework of the technical documentation and quality management system. Manufacturers first need to recognize the complexity & detail of the IVDR, which will in turn require more resources to maintain as well as implement, and then work preemptively to achieve compliance.