What will the new EU regulations mean for in vitro diagnostics?
In 2022 the long-running IVDD will be replaced by another system called IVDR, thus inaugurating a new era for the regulations of InV. Manufacturers aiming for European market access to receive the CE label will face more stringent, more thorough considerations.
The IVDR is expected to replace the IVDD by 25 May 2022 and be adopted by all European Union member states. The IVDR presents an enormous change to IVD Industry because, e.g., in terms of its change in documentation and quality management system.
Why is this change so important for IVD manufacturers?
The directive on the IVDR Directive was compiled for a comparatively young industry that failed to have a large scope or scale-up. With industry evolution, this directive is no longer effective.
The new directive also addresses challenges posed by the directive, including the introduction of a rules-based classification system for products, a new based classification system, and replacing the list-based method.
This makes the Regulation practical by allowing it to remain relevant to the growing innovation industry. Furthermore, it means a much longer number of IVD manufacturers require that a notified certify their products because the classification rule applies to all IVDs instead of using an exclusive list of specific products.
IVDR – In Vitro Diagnostic Medical Devices Regulation (EU)
Regulation (EU) 2017/746 – also known as the Regulation on Diagnostic In Vitro Medical Devices (IVDR regulation)- took effect on 25 May 2017. The transition period is five years. The proposed regulation will take effect from May 26, 2022, onwards.
When compared to IVDD, the industry faces major challenges. These provisions have been revised. The regulatory department will scrutinize the respective documents more thoroughly.
The ‘new EU regulation’ measures the validity of scientific, medical, and psychopharmacologic methods in three areas: scientific validity. Under IVDR, scientific validity has been introduced.
Analytical performance defines the Ability of the device to detect and analyze a particular analyte, while clinical performance defines the Device’s ability to yield results that correlate.
Collaboration, analysis, and evaluation of data need to perform in an assessment report. The most significant separation between IVDD and IVDR, in this case, is the fact that in the current set of regulations, the conduct of one of the articles is not explicitly necessary.
The analysis of performance but articles 56 provides in the proposed contexts.
What happens after conformity establishment?
EuropeDAMED aims to develop a system focused on the IVD’s life cycle. For IVD, the manufacturer will refer to great dangers to that body of notification and submit regular updates.
Severe incidents that require repairs or replacements are also responsible for the manufacturer. If they find it significant, the report must address any member states in the EU concerned directly.
A compliance certificate has been valid for five years; therefore, the system will restart all 5 years from now. However, the regulation requires that each IVF drug passes through periodic updates of the IVD certification process that started five years after their certified certification.
One of the requirements regarding safety in IVDR is risk management. Manufacturers will state measures that will eliminate or decrease the risks associated with using that equipment.
” A further requirement would include a description of where they have put into a practice safeguarding against noncomplicated hazards, and providing information to users on previously unexplained residual risks. “
It requires that the benefit of such a drug should outweigh any known and foreseeable risks resulting from their normal usage. Nevertheless, the evidence will remain accepted, which could reduce the number of unnecessary and time-consuming studies.
IVDR Part II – Your Technical Documentation and Performance Evaluation
In the previous article, we have discussed some of the significant changes to be considered in the EU IVDR. Like increased regulatory oversight, expanded clinical evidence requirements, more critical requirements for IVD manufacturers, and intensified supervision of Notified Bodies.
This article furthers down the new vocabulary of IVDR devices. Stressing the components of Technical documentation and performance evaluation that are paramount to conformity.
What changes does the IVDR make to diagnostic compliance?
These devices must now be input in EUDAMED (European Databank on Medical Devices). This new standard also includes new rules to regulate the use of standard nomenclature, improve post-After PIP scandal, and expose the problems with self-certification. Still, another important change has become requirements for the use of contact bodies oversight on compliance for far more equipment.
Before implementing NBs, they must ensure compliance with their products. Only the lowest-risk classification (class A) doesn’t store NB intervention. The producers have to implement systems for the protection of transparency.
EU IVDR – Expanded Product Scope
Understanding the new vocabulary, knowing use, and indications of use in the scope of the IVDR are crucial first steps in achieving compliance.
Self-testing devices previously for use in the “home environment” have been redefined as “to be used by laypersons.”
A test done by a patient will examine self-testing, regardless of the location. Now, self-testing devices and near-patient testing devices require to undergo a premarket approval approach.
Single-use devices willfully used during a single procedure that was part of the MDD have been introduced in the IVDR.
This information must be mentioned on the label, in the Instructions for Use (IFU), and the registration information for the IVD’s UDI. This affects user information and the 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, suppose the device is a single, non-reusable product, not intended to be used alone, except in the given combination. In that case, the combination product is regulated under the medicinal product’s framework.
Also, if the medical device and the medicinal product are not physically related to each other, the device will be CE marked.
The kit specifies a set of components packaged together and intended to perform a specific examination or part. 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
Following the IVDR, critical components of Technical Documentation that play quite a significant role in the conformity route are:
- 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 of what the device is, its intended use, and technical specifications.
The technical documentation 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 identifying risks such as foreseeable product misuse and mitigation.
There is a preference for design changes to eliminate hazards as far as possible (Design control) critical Following state of the art and 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 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 including an essential requirement to demonstrate
- Labeling 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 represents a three-step process:
- Planning the evaluation,
- Collecting the clinical evidence based on data that shows the scientific validity and the analytical and clinical performance,
- 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 must continuously review the PER to ensure it reflects the state of art. Following 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 that needs to review; and how it should be defined within a Quality Management System (QMS).
The Post Market Performance Follow-up (PMPF) is an essential 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 following the IVDR. For example, this could result in Class I medical device consisting of a Class D IVD that must obtain certification from an 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 demanding requirements. This will undoubtedly result in a tremendous amount of work if there is no development of appropriate procedures.
In the coming years, the evolution of the IVDR will change expectations and lead to an inevitable rework of the technical documentation and quality management system.
Firstly, Manufacturers must recognize the complexity & detail of the IVDR, which will, in turn, require more resources to maintain and implement. Lastly, work preemptively to achieve compliance.