European In Vitro Diagnostic Medical Device Regulation (EU-IVDR) has been saved
European In Vitro Diagnostic Medical Device Regulation (EU-IVDR)
A significant upgrade of the regulatory framework
The EU-IVDR came into effect as of May 2022 and has replaced the In Vitro Diagnostics Medical Device Directive 98/790/EC (IVDD), laying the basis for safe IVDs market entry and maintenance. However, the process of obtaining CE marking for IVDs can be long and complex.
In Vitro Diagnostic (IVD) Medical devices are tests used to monitor the health status of a human being.
IVDs are governed In Europe under the European in Vitro Diagnostic Medical Device Regulation 2017/746 (EU-IVDR).
The EU-IVDR came into effect as of 26 May 2022 and has replaced the in Vitro Diagnostics Medical Device Directive 98/790/EC (IVDD).
The presence of the CE-mark makes the device eligible to be sold in the EU market and guarantees that the applicable legal requirements are met and that the IVD is safe for use and performs as intended.
Compared to the directive, the EU-IVDR demands:
- Greater transparency
- Enhanced harmonization and standardization
- More regularity scrutiny
- Increase in obligations and oversight of economic operators and notified bodies
- More stringent criteria for clinical evidence and performance evaluation
- Heightened traceability across supply chain through Unique Device Identification (UDI)
In addition, stricter requirements are being introduced that affect many functions and activities of an organisation, especially those related to:
- Cyber safety and Privacy
- Quality Management System (QMS)
- EUDAMED and Unique Device Identification (UDI)
- Clinical evidence, performance evaluation and performance studies
- Technical documentation
- Economic operators and the Person Responsible for Regulatory Compliance (PRRC)
- Post market surveillance (PMS) & Vigilance
- Classification, Conformity Assessment and Consultation
How to qualify and classify an in Vitro Diagnostic?
According to the EU-IVDR, In Vitro Diagnostic medical device means “any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, piece of equipment, software or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body ”.
Examples of IVD medical devices are pregnancy tests, urine test strips, HIV or COVID 19 tests. All in Vitro Diagnostic medical devices shall comply with the general safety and performance requirements laid down in the EU-IVDR. Compliance should be demonstrated by the application of (harmonized) standards and common specifications.
In Vitro Diagnostics are classified into 4 classes by taking into account the intended purpose of the device and its inherent risks.
- Class A: low individual risk and low public health risk
- Class B: moderate individual risk and/or low public health risk
- Class C: high individual risk and/or moderate public health risk
- Class D: high individual risk and high public health risk
The risk classification system has been established following seven classification rules described in ANNEX VIII of the EU-IVDR. The manufacturer is responsible for applying the right risk class to its In Vitro Diagnostic medical device, and to provide a justification for the classification rule(s) applied. Wrong classifications that result in a deviated conformity assessment route may cause delays in the regulatory planning, product development and in the final market authorization.
Manufacturers are allowed to self-certify Class A non-sterile IVD devices. Class A sterile, Class B, C and D IVD devices require certification by a Notified Body. The higher the risk class of the device, the more regulatory scrutiny and stricter regulatory requirements apply for conformity assessment of that device.
The entire certification process could take up to 18-24 months, or even longer depending on the risk class, the status and maturity of the technical documentation and QMS, and the availability of a Notified Body. This means that manufacturers should start early with preparing for EU-IVDR and act within proper timing to allow a smooth transition to the EU-IVDR.