Compliance Expert Insights on IVDR: Understanding the Impact

June 28, 2023
In-Vitro diagnostics

With the new In Vitro Diagnostic Medical Device Regulation (IVDR) in place, IVD manufacturers are now subject to much more stringent regulatory requirements and processes, especially when compared to the previous In Vitro Diagnostic Medical Device Directive (IVDD). These new regulations first became effective in 2017 to address key issues identified with the previous regulations.

One key aspect that stands out in the new IVDR is the enhanced conformity assessment with notified bodies. Moreover, medical devices that have been previously certified under the IVDD must also undergo the process again under the new regulations, in accordance with a timeline depending on the classification of the device. On the other hand, new IVD devices must fully comply with the IVDR before they can be brought to the market.

The new regulations also require companies to present clinical data and evidence, which is one of the most challenging aspects of the new and updated process. Companies are also required to compile comprehensive documentation, which is where most companies and manufacturers tend to fall short.

Navigate the challenges of IVDR with our expert guidance

With the greater challenges brought about by the new regulations, companies are in a prime position to benefit from the expert guidance of IVD and medical device consultants. Key2Compliance can help you from the initial stages, up to planning your post-market activities and maintaining regulatory compliance.

Susanne Grimsby, Senior Consultant of Regulatory Affairs, is one of the experts who uses her knowledge and expertise in regulatory affairs and quality assurance (QA/RA) for IVD devices and medical devices. With over 30 years of experience in the Life Science industry and 9 years of experience in the medical device industry, Susanne has an extensive background in working with small- and mid-sized medical device and IVD companies, working on the implementation and maintenance of quality management systems and preparation of technical documentation. She is also used to take part in product development, guiding the regulatory framework and leading activities such as risk management among others towards the CE-marking.

Working alongside Susanne is Emily Malmberg, an experienced consultant in Clinical Development. Emily has over 18 years of experience in life science research, with a PhD in Biomedicine from Gothenburg University, Sweden/Mayo Clinic, Scottsdale AZ, USA, and an MSc in Biomedicine from Lund University in Sweden. Emily has extensive experience in the IVD industry, having worked as a Clinical Affairs Specialist responsible for collecting and documenting performance data for IVDR compliance.

Understanding the IVDR certification process

Having a clearer picture of the whole certification process can provide IVD companies and manufacturers with a better understanding of what steps need to be fulfilled to meet certification. Following and executing these steps accordingly is key to seamlessly meeting regulatory compliance.

Generally, the first step is identifying the qualification and the classification of the device. Before proceeding with the certification process, medical device companies must first identify under what classification their device falls, or if their device is even classified as an IVD device.

According to Susanne, while most IVD companies are already aware of the classifications, many are still struggling in interpreting them. “Most of the IVD companies are aware of the new classifications, but a lot are having difficulties in understanding the classifications and the rules that should be applied,” says Susanne. She also states that this is one of the biggest challenges of the new regulations.

The next step is the preparation of technical documentation, which must be prepared or updated according to IVDR Annex II – Technical Documentation. Emily emphasized that the new regulations require a much higher degree of clinical data. “One of the main things that is new about the IVDR is the much higher requirement for clinical evidence and data on your device,” she says.

Many companies do not have the clinical evidence required by the IVDR.”

With the IVDR requiring more clinical data and clinical evidence from companies, Emily states that many of these companies are struggling to meet these requirements for their device. “Many companies do not have the clinical evidence required by the IVDR.” In this regard, Emily states that they perform a gap analysis to identify the clinical evidence that needs to be added to meet the requirements of the IVDR. “If there are gaps, we can inform the client and help them produce the clinical data that they need,” says Emily.

Following this step is the establishment of a quality management system (QMS), which must be prepared or updated according to IVDR Annex IX, Chapter I – QMS. Going back to steps 1 and 2, if your medical device falls under class B, C, or D, then the technical documentation of your device must be submitted to a notified body for conformity assessment and your QMS and eventual manufacturing facility will be audited.

Once all requirements are met, the notified body will issue a CE-certificate that confirms the compliance of your device with the IVDR. Your device can then be placed on the EU market. Afterward, the compliance of your device must still be maintained through continuous monitoring and assessment of its safety and performance.

“It is best not to delay and not to wait too long to start the process.”

Emily Malmberg stressed the importance of not waiting for too long before having your device certified, and that it would be best to set the regulatory strategy and the clinical strategy at the same time. Lead times of conformity assessment by a notified body can be long and the effort to demonstrate compliance tedious. Given the rigid requirements under the new IVDR, the process potentially can be time-consuming. Companies whose devices were certified under the previous IVDD that now need to acquire certification under the new IVDR should carefully investigate the requirements that are applicable for their particular classification and the timeline they have to adhere to not to risk having their certifications revoked. “If you believe that you have gaps in your technical documentation, it is best not to delay and not to wait too long to start the process” says Emily.

Partner with Key2Compliance and take control of your IVD company’s IVDR compliance. Our expert team will guide you through the complex regulatory landscape, ensuring you understand the impact of IVDR and navigate the certification process with confidence. From identifying device qualifications to gathering clinical evidence and establishing a robust quality management system, we provide tailored strategies and gap analyses to meet IVDR requirements. Start the process without delay, as lead times for conformity assessment can be long. Key2Compliance enables you to achieve regulatory compliance in the IVD industry – Rely on us!

Would you like to find out more about how Key2Compliance can help IVD manufacturers stay ahead of the competition and maintain their market position? Click here and get information about key changes, timelines, and how to ensure compliance with the new IVDR requirements.