The forthcoming In-Vitro Diagnostic (IVD) Device Regulation is approaching the final stages of the review process before becoming law and is the proposed revision to the existing IVD Directive, 98/79/EC.
The IVD Regulation is significantly different to the current IVD Directive, including changed classification rules and requirements for conformity assessment. It is intended to strengthen the current approval system for in-vitro diagnostics, making substantial changes to the existing IVD Directive (98/79/EC) legislation, first introduced in 1998.
Introduction to the IVD Regulation
Due to constant scientific and technological progress, the IVD Directive, 98/79/EC is no longer ‘fit for purpose’. Substantial divergences in the interpretation and application of the rules have emerged overtime, thus undermining the main objectives of the Directive.
The proposed revision, published by the European Commission aims to provide a robust, transparent and sustainable regulatory framework for in-vitro diagnostic medical devices.
The revision is being introduced as a Regulation instead of a Directive. A Regulation has been determined to be the most appropriate legal instrument, because it imposes clear and detailed rules which do not give room for divergent transposition by member states. Moreover, a Regulation ensures that legal requirements are implemented at the same time throughout the Union.
The proposed Regulation introduces a new risk-rule classification system based on the Global Harmonization Task Force (GHTF) classification rules.
This change to the classification system will have an impact on all manufacturers of IVDs. The majority of IVDs are currently self-certify, but once the Regulation comes into effect, most will require the services of a notified body to classify their devices.
Under the existing directive approximately 80% of IVD’s on the market in the EU are self-declared devices where the manufacturer has sole responsibility for meeting the requirements of the directive. Under the new regulation 80% of IVD’s will require some form of conformity assessment by a notified body.
Scope of Regulated IVD Products
The Regulation clarifies and expands the scope of regulated IVD devices to include:
- Tests providing information about the predisposition of a medical condition or disease
- Tests providing information to predict treatment response or reactions
- Medical software, which is explicitly mentioned in the definition of IVDs
- Devices manufactured and used within a health institution.
Classification and conformity assessment
In the new classification system, IVD devices will be divided into four Classes of risk: A (lowest risk), B, C and D (highest risk). By using the seven classification rules, devices will be divided into one of the four classes that will dictate notified body involvement.
The conformity assessment procedure for lowest-risk Class A devices will be the sole responsibility of the manufacturer, except when they are intended for self-testing, near-patient testing, or are sold sterile. In these cases, a notified body is required to verify the design,or sterilisation process. Class B, C, and D devices are characterised by increasing risk levels and will all require notified body involvement. 15
Person responsible for regulatory compliance
It will be a requirement that manufacturers have available within their organisation at least one responsible person accountable for regulatory compliance who possesses expert knowledge in the field of in-vitro diagnostic medical devices.
Identification and traceability
Manufacturers must fi t their devices with a Unique Device Identification (UDI). The proposed Regulation gives full details of the information that has to be accessed through the UDI.
Additionally, manufacturers of high-risk devices are to make publicly available a summary of safety and performance with key elements of the supporting clinical data.
Performance evaluation report
To demonstrate conformity with the general safety and performance requirements, a performance evaluation report, proportionate to the risk Class, is required.
Vigilance and market surveillance
The EU Commission proposes to set up and manage an electronic system to collate and process reports by manufacturers on serious incidents, field safety corrective actions, field safety notices and periodic summary reports. Manufacturers of devices classified in Class C or D will also have to report any statistically significant increase in the frequency or severity of incidents that are not individually serious incidents, but which have an impact on the risk-benefit analysis.
The position of notified bodies in relation to manufacturers will be significantly strengthened. They will have a right and duty to carryout unannounced factory inspections and to conduct physical or laboratory tests on devices. The proposal also requires rotation of the notified body’s personnel involved in the assessment of IVDs at appropriate intervals to strike a reasonable balance between the knowledge and experience required to carry out thorough assessments.
Timetable for introduction and transition
The new Regulation will become applicable five years after its entry into force, to take into account the significant changes to the classification system for IVDs and to the conformity assessment procedures. This may be one year after its entry into force. The expected publication date is early 2016.
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