The new IVD Regulation was published on 5 May 2017 and becomes applicable on 25 May 2022; five years after entering into force. The IVDR significantly differs from the outgoing IVDD, with new requirements aiming to provide a robust, transparent and sustainable regulatory framework for in vitro diagnostic medical devices.
Due to constant scientific and technological progress, the IVDD was deemed no longer ‘fit for purpose’. Substantial changes in the interpretation and application of the rules emerged, undermining the objectives of the Directive.
The revision is being introduced as a regulation instead of a directive as it is the most appropriate legal instrument to impose clear and detailed rules for member states that are implemented at the same time throughout the EEA.
Scope of regulated IVD products
The Regulation clarifies and expands upon the scope of regulated IVD devices to include:
- Tests providing detail about the predisposition of a medical condition or disease
- Tests providing information to predict treatment response to medicines
- Medical software as included in the definition of IVDs.
Classification and conformity assessment
The IVDR introduces a new risk-rule classification system based on the Global Harmonization Task Force (GHTF) rules for classification, considering patient impact for the first time. The new classification system divides IVD devices into four Risk Classes:
- A - lowest risk
- B, C and D - highest risk.
By using seven classification rules, devices will fall into one of the four classes to dictate Notified Body involvement. The conformity assessment procedure for Class A devices will be the sole responsibility of the manufacturer; Class B, C and D devices are characterised by increasing risk levels, so each requires increased Notified Body involvement.
The new classification rules will have an impact on manufacturers of IVDs as it requires some form of Notified Body involvement for about 80% of IVD devices on the market compared with about 15% under the IVDD.
- Under the IVDD, about 80% of IVD’s on the EU market are self-declared, where the manufacturer takes sole responsibility for meeting the directive requirements
- Under the IVDR, 80% of IVDs require some form of conformity assessment delivered by a Notified Body
This means the majority of IVD manufacturers, who have never had to engage with a Notified Body, will be required to have both their Quality Management Systems (QMS) and technical documentation audited for the first time.
Identification and traceability
Manufacturers must fit devices with a Unique Device Identification (UDI). Additionally, manufacturers of high-risk Class C and D devices must provide a publicly-available safety and performance summary, including the key elements of supporting clinical performance.
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
An electronic portal will be introduced through which manufacturers can report serious incidents, safety corrective actions, field safety notices and periodic summary reports.
The position of Notified Bodies in relation to manufacturers will be significantly strengthened. Notified Bodies will have the right and duty to perform unannounced factory inspections as well as physical or laboratory tests on devices.
The regulation 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 needed to complete comprehensive assessments.
Timeline for introduction and transition
The new Regulation was published on 5 May 2017 and entered into force on 25 May 2017. The IVDR becomes applicable five years after entering into force.
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