IVDR compliance made simple – Expert guidance for your business

IVDR stands for In Vitro Diagnostic Regulation. It is a regulation in the European Union that sets the standards for in vitro diagnostic medical devices (IVDs). It was adopted in 2017 and became applicable in May 2022.

IVDR applies to all manufacturers of in vitro diagnostic medical devices who intend to place their products on the market in the European Union.

IVDR introduces several changes to the regulation of IVDs in the European Union. Some of the key changes include the introduction of stricter requirements for clinical evidence, The introduction of person responsible for regulatory compliance (PRRC), increasing requirements on post market surveillance (PMS), increasing requirements on quality management systems and the establishment of a unique device identification (UDI) system.

Manufacturers can comply with IVDR by ensuring that their IVDs meet the requirements set out in the regulation. This includes harder requirements on clinical data, having a Person responsible for regulatory compliance (PRRC), post market surveillance (PMS) system, implementing a quality management system, and registering their devices with the European database on medical devices (EUDAMED).

Some common challenges include identifying the correct classification for their IVD device, if applicable contracting with a notified body, ensuring their technical documentation meets IVDR requirements, updating their quality management system (QMS), and training staff on new regulations and processes. Additionally, the shortage of notified bodies has led to delays and increased competition for their services, making it even more important for companies to plan and prepare ahead of time.

A notified body is an organization designated by a European Union member state to assess the conformity of certain products with the relevant EU legislation, such as the IVD devices class B, C and D. They are responsible for performing conformity assessments, which involves reviewing technical documentation, conducting audits, and issuing certificates of conformity. You need a notified body, if you have a divice classified as B, C or D to certify your IVD device for CE marking and to sell it on the EU market.

You should choose a notified body that is designated for the type of IVD device you are manufacturing, as well as one that has experience in your specific field. You should also consider their availability, fees, and reputation. The European Commission maintains a list of designated notified bodies on the NANDO database, which you can use to find and compare potential candidates.

It depends on the device and the level of clinical evidence required for compliance. Some devices may require new investigations, while others may be able to use existing data. It is important to review the regulation and seek guidance from notified bodies or regulatory consultants.

Yes, for a limited time if you don’t do any significant changes. But all new IVD devices need to directly comply to IVDR directly.

IVDR may pose a significant challenge for small businesses and startups due to the increased requirements for clinical evidence, performance evaluation, and economic operators. However, there are resources available to help companies navigate the compliance process.

The clinical evidence requirements under the IVDR are more stringent than those under the IVDD, so you may need to generate additional clinical data to demonstrate compliance with the new regulations. However, you may be able to use some of the same data if it is still relevant and up-to-date, and if it meets the new requirements. You should consult with a notified body or regulatory expert to determine what evidence you will need for IVDR compliance.

The timeline for certification can vary depending on the device classification, the availability of notified bodies, and the complexity of the device. It is recommended that companies begin the process as soon as possible to avoid delays.

There are no general exemptions or exceptions to IVDR compliance, but some devices may fall under certain derogations. It is important to review the regulation carefully to determine if any derogations apply.

Non-compliance with IVDR can result in serious consequences for manufacturers. This includes the inability to place their products on the market in the European Union and could incur financial penalties.

The European Commission website provides comprehensive information about IVDR, including guidance documents, FAQs, and other resources. Additionally, manufacturers can consult with notified bodies and regulatory experts to ensure compliance with the regulation.

Analytical sensitivity, analytical specificity, trueness (bias), precision (repeatability and reproducibility), accuracy (resulting from trueness and precision), limits of detection and quantitation, measuring range, linearity, cut-off, including determination of appropriate criteria for specimen collection and handling and control of known relevant endogenous and exogenous interference, cross-reactions.

Yes if there are parts in direct, or indirect contact with the patient.

Yes, if the it contains substances in amounts that are classified as hazardous according to CLP or if the requirements of article 31.3 in the REACH regulation are met.