EU IVDR: Ensure compliance with technical documentation, notified body processes and transition periods

In Vitro Diagnostic (IVD) medical devices play an essential role in healthcare, enabling early disease detection and diagnosis that lead to more effective treatments, better patient outcomes and in addition improve management of chronic, infectious and various other health conditions.

The requirements for IVD medical devices in the European Union (EU) have undergone significant changes with the introduction of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVD regulation, IVDR), which came into force on May 26, 2022. Manufacturers shall ensure the conformity of IVD medical devices being placed on the EU market in accordance with the applicable requirements of the IVDR.

Recognising the challenges posed by the introduction of IVDR, transition periods have been introduced to allow manufacturers and other stakeholders time to adapt. These transition periods are designed to offer a grace period during which devices that were previously compliance under the old directive can continue to be placed on the market, allowing manufacturers additional time to ensure their devices comply to the updated regulatory standards. The latest IVDR amendment that updated the transition timelines was published in July 2024.

A notified body is often needed in the IVDR conformity process to ensure that IVD medical devices meet the tightened safety, performance and quality requirements set by the IVDR, ensuring patient safety and a good performance of the device. Most IVD devices must undergo a third-party assessment by a notified body to verify that they comply with the regulation. Only manufacturers of non-sterile Class A devices are able to self-certify their products, which means that about 80–90% of the IVD medical devices will require CE certification by a notified body.

Depending on the classification of the device and the conformity assessment route chosen, the notified body evaluates the manufacturer’s technical documentation, including design, performance, and safety and clinical data, to confirm that the device is in compliance with the regulatory requirements.

Understanding the technical documentation requirements, how long the notified body conformity processes take, and the necessary transition periods of the IVDR is important for compliance and market success. This post will look at these key factors in detail.

Technical Document requirements under the IVDR

One of the most significant changes with the IVDR is the enlarged technical documentation requirements for IVD medical devices. These documents are now more detailed and comprehensive, providing a clear demonstration of the device’s safety, performance and compliance with the regulatory requirements and standards. The technical documentation requirements are described in Annex II and post-market surveillance requirements in Annex III of the IVDR.

Technical documentation shall include the following key sections:

• Device Description and specification, including variants and accessories: descriptions of the device and its components, intended purpose and users, classification and Basic-UDI-DI.
• Information to be supplied by the manufacturer: label(s) and instructions of use.
• Design and manufacturing information: information on the design stages including critical ingredients, analytical technology, system description, and algorithm details. Manufacturing information and identification of all sites.
• General safety and performance requirements: demonstration of conformity with each applicable requirement in Annex I with reference to the used methods, i.e. harmonised standards, common specifications, or other solutions applied.
• Benefit-risk analysis and risk management: A risk management file demonstrating how risks related to the device are identified, assessed and mitigated according to the ISO 14971 standard. A benefit-risk analysis for evaluating if the device’s benefits outweigh the potential risks to patients, users, and the environment.
• Device Verification and Validation: The clinical evidence of the device in the form of performance evaluation that includes the information on analytical and clinical performance and scientific validity, as well as stability and other relevant verification and validation information.
• Post-Market Surveillance: an active and systematic process for monitoring and assessing the performance and safety data of an IVD device after it has been placed on the market, to ensure continued compliance and identify any issues or risks.

Manufacturers must maintain up-to-date and comprehensive technical documentation that is available for review by regulatory authorities throughout the lifecycle of the device.

In addition to the technical documentation, manufacturers must maintain documentation related to a quality management system in accordance with the IVDR Article 10(8).

Notified body processes timeline under the IVDR

The transition from Directive 98/79/EC on in vitro diagnostic medical devices (IVD Directive, IVDD) to the IVDR introduces several challenges, particularly in relation to the notified body assessment process. With a more comprehensive risk classification system and tightened requirements, more devices need to be certified by a notified body and the timeline for obtaining certification has increased.

A notified body is a third-party entity that has been accredited to assess the conformity of manufacturers and devices with applicable EU regulations. Notified bodies have had to go through a new designation and notification process under the IVDR. As a result, there are currently only 12 notified bodies designated under the IVDR in the beginning of the year 2025. A smaller number of notified bodies means that those designated under the IVDR will have limited capacity to handle new conformity assessment applications.

Not all notified bodies are designated for specific types of IVD devices. The IVDR and implementing regulation (EU) 2017/2185 outline various device-related codes that specify the areas each notified body is authorised to assess, indicating which device categories they can handle. When applying for conformity assessment including relevant technical documentation and quality management system information, manufacturers must also assign the appropriate codes to their IVD device, and the notified body will verify the accuracy of these codes.

Typical reasons for refused applications are for example wrong classification of device, wrong conformity assessment procedure or that application is not complete. Depending on the conformity assessment route of the device, the time the process takes varies. The certification process can take 13-18 months or more due to the tightened requirements and limited time and capacity of notified bodies.

In terms of the successful processing of IVDR applications, one of the critical factors in the process is the quality and structure of the technical documentation submitted for evaluation. The most frequent causes of delays in Technical Documentation assessments are:

• incomplete documentation – missing required information from the manufacturer
• poor structure of the documentation – hard-to-follow documentation that complicates verification of regulatory compliance
• incorrect references – general references instead of specific sources. Thus, it is critical to plan and initiate the IVDR certification process as early as possible to avoid unnecessary delays of the process.

Transition periods under the IVDR: what manufacturers need to know

Currently, we are over 30 months into the IVDR after the original Date of Application (26 May 2022) and adapting is still on-going. The IVDR includes transitional provisions for devices already on the market under the IVDD (legacy devices). To be able to utilise the transition periods, certain conditions have to be met:

• the legacy devices continue to comply with the IVDD,
• there are no significant changes in the design and intended purpose,
• the devices do not present an unacceptable risk to the health or safety of patients, users or other persons, or to other aspects of the protection of public health,
• no later than 26 May 2025, the manufacturer has put in place a quality management system in accordance with Article 10(8),
• a formal application with a notified body has been lodged within risk-class dependent timelines, the notified body and the manufacturer have signed a written agreement within risk-class dependent timelines

The timeline for the transition period is described briefly in the below figure. For more details, please take a look at our previous blog:
What to know about medical device and IVD class changes and transition periods?

Key IVDR changes to fulfil

The transition to the new IVDR regulatory framework presents both challenges and opportunities for IVD medical device manufacturers. Manufacturers must initiate their conformity assessment procedures well in advance to avoid delays, ensuring they meet the requirements of the IVDR.

Despite the transition period, the manufacturers should remember that the requirements relating to post-market surveillance, market surveillance, vigilance, registration of economic operators and devices, and obligations in case of interruption or discontinuation of supply of certain devices apply to legacy devices already during the transition period.

If your organisation needs extra hands to fulfil the IVDR requirements, do not hesitate to contact Medfiles IVD experts.

See also:

• How to gather clinical evidence for IVD performance evaluation under EU IVDR?
• What to know about medical device and IVD class changes and transition periods?