In less than 430 days, the In Vitro Diagnostic Regulation will fully replace the EU’s current Directive on in vitro diagnostic medical devices (IVDD 98/79/EC). Are you prepared for the transition?
What is In Vitro Diagnostic Regulation (IVDR)?
The IVDR is the new regulatory basis for in vitro diagnostic medical devices on the European market. With a wider scope and more rigorous requirements, the IVDR will impact the entire supply chain. The IVDR was introduced on May 26, 2017, allowing for a five-year transition period for manufacturers selling IVD medical devices into European markets. Many manufacturers must perform additional clinical and performance studies in order to comply with IVDR requirements, since grandfathering is no longer possible. Starting May 26, 2022, new devices will have to meet the requirements of the IVDR in order to be placed in the European market—devices cannot legally be sold without the IVDR certification after this date.
What are the changes from the IVDD?
The transition from a directive to a regulation aims to establish a broader scope of protection and more efficient implementation of the rules on IVDs. Access to the European market will be stricter for IVDs, as will the requirements for manufacturers, importers, distributors, and notified bodies. In addition, the IVDR will tighten restrictions for Research Use Only (RUO) products. Many current IVD products on the market are identified as RUO, meaning that the IVD cannot be used to for any clinical applications, such as a component in a Lab Developed Test (LDT). This regulatory change will hold manufacturers responsible for proper use of RUOs, rather than the user. The goal of the regulation is to advance protection of public health as well as patient safety.
Under the regulation, IVDs will retain all existing IVDD requirements and add new ones, including:
- new classification into four risk classes
- a more precise description of the analytical and clinical performance of IVDs
- requirements for manufacturers to establish and demonstrate effective quality management systems (QMS)
- stricter requirements for the conduct of clinical trials
- more precise execution and planning of post-market monitoring and reporting
- introduction of unique device identifiers (UDIs) for better traceability of IVDs
- more transparency for patients
What are the benefits from this transition?
- Some of the intended benefits of IVDR include:
higher standards of quality, safety, and reliability of IVDs
- clearer definitions of what an IVD is and how they are classified, surveilled, and regulated
- improved oversight and traceability across the supply chain and throughout the device lifecycle
- better ability to accommodate new technologies and scientific advances
- facilitation of global trade through the promotion of more convergent regulations
The IVDD lacked broad scope and scalability and ultimately has become outdated. The new regulation addresses many of these issues, and it will more successfully be able to remain relevant in a changing industry. While this is a step in the right direction, there’s a limited amount of time left to transition to these new requirements, and many IVD manufacturers still have a lot of work ahead of them. MEDIcept is prepared to assist any companies that are crunched to meet this approaching deadline. Please contact us for more details on transition and compliance.
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MEDIcept is an international consulting firm offering a full portfolio of services to the medical device and IVD industry. For over 25 years, our unique consulting practice and multidisciplinary team of former FDA, Notified Body, and industry experts have assisted hundreds of companies of all sizes with innovative, compliant, trusted, and cost-effective Regulatory, Quality, Clinical, and Engineering solutions.
For additional information, please contact Susan Reilly at SReilly@MEDIcept.com.