How Does IVD Registration Process Change with New EU Regulations?


Manufacturing of in-vitro diagnostic devices (IVD) is set to change with new regulations set by the European Union (EU). According to the recent update in the EU Regulation 2017/746, medical device manufacturers are likely to face several changes in the IVD registration process. This major update brings forth more compliance to the regulatory framework for IVD manufacturers under the EU. Registration of IVDs is expected to become more modernized under this new European regulatory system.

What is IVD registration?

Before understanding how the new IVD registration process is changing, let’s explore the process before the EU regulatory update. In the field of In-vitro Diagnostics, medical device manufacturers need to follow a process for the commercialization of IVD devices. In most healthcare markets, including the EU medical device market, manufacturers are required to follow a registration framework to get necessary approvals from the regulators.

This IVD registration process primarily involves obtaining the European CE Marking certification for IVD products. To get this approval, IVD manufacturers demonstrate the compliance of their products with the In Vitro Diagnostics Directive IVDD 98/79/EEC during the registration process.

New Changes in IVD Registration

With the recent EU regulatory update, IVD registration is set to undergo several changes. From regulatory documentation improvements to IVDR product registration outside of EU and EEA, these changes are being addressed to all IVD manufacturers and economic operators around the world.

From early-2022, the EU will enforce new rules to redefine IVDs at pre-approval and post-approval stages of the registration. Here are some key changes in the IVD registration process:


  • Medical device manufacturers can include non-medical products such as epilation lasers and cosmetic products such as contact lenses in the IVD category. This helps the manufacturers to expand their product lines and register more products for regulatory approvals.
  • Genetic test kits are also covered in the new IVD registration process. These IVD tests can be registered under patient therapeutics during approvals.
  • New rules require IVD manufacturers to demonstrate clear and higher evidence during the experimental stage of the process. Their experimental IVD products need to pass various levels of safety through effective evidence before getting approved for widespread use.
  • These new changes also affect the production of existing IVD products. Hence, manufacturers are compelled to seek recertification of existing IVD products. This emerges as a key challenge for most medical device manufacturers. If an existing IVD product fails the registration process during recertification, it can entail economic losses through product recalls.

Why is this New IVD Registration Important?

The new changes in IVDR aim to address concerns such as end-user transparency and patient safety. IVD markets are likely to be influenced by these increased expectations for clinical evidence. Under strict scrutiny, manufacturers will need to maintain and provide more data to competent authorities and notified regulatory bodies. The traceability of these products throughout the supply chain is also crucial under the new changes in the IVD registration process. The EU is also stepping up its safety monitoring through different stages of quality control and assurance. Going forward, this will emerge as a new regulatory task for IVD manufacturers in the EU and outside.